Dry Eye Syndromes
Conditions
Keywords
Dry eye
Brief summary
The purpose of the study is to evaluate dose-response, efficacy and safety of CP-690,550 eye drops in patients with dry eye disease.
Interventions
DRUGCP-690,550 Eye drops
Ophthalmic topical solution, low dose, dosed once/day, 8 weeks
DRUGCP-690,550 Eye drops-vehicle
Ophthalmic topical solution, vehicle, dosed once/day, 8 weeks
DRUGSodium Hyaluronate
Ophthalmic topical solution, dosed 6 times/day, 8 weeks
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjective symptoms of dry eye for at least 6 months * Signs of moderate to severe dry eye (corneal staining score and schirmer test without anesthesia)
Exclusion criteria
* Women who are nursing, pregnant or planning pregnancy during the study * Participation in other studies within 30 days of screening visit * Ocular disorders that may confound interpretation of study results
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Corneal Staining Scores for Study Eye From Baseline at Week 8 | Baseline, Week 8 | Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale:0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Demonstrating 100 Percent Clearing of Corneal Staining for Study Eye | Week 1, 2, 4 and 8 | Percentage of participants demonstrating corneal staining score = 0 which indicates no damage in corneal surface. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. |
| Changes in Conjunctival Staining Scores (Interpalpebral) for Study Eye From Baseline | Baseline, Week 1, 2, 4 and 8 | Based on the Oxford grading system, the bulbar conjunctiva of each eye was divided into 2 different zones (nasal and temporal). The nasal and temporal bulbar conjunctival zones were each graded independently using a 6-point scale (0 \[Absent\] to 5 \[Severe\]). Total score ranged from 0 (Absent) to 10 (severe), higher score=higher damage to eyes due to dryness. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change = scores at observation minus score at baseline. Negative change from baseline indicated improvement. |
| Changes in Tear Break Up Time (TBUT) for Study Eye From Baseline | Baseline, Week 1, 2, 4 and 8 | TBUT is the interval between the last complete blink and the first appearance of a dry spot, or disruption in the tear film. Using a stopwatch, the time between last complete blink and first appearance of dry spot was recorded. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: value at observation minus value at baseline. Positive change from baseline indicated improvement. |
| Changes in Schirmer Test Values Without Anesthesia for Study Eye From Baseline | Baseline, Week 1, 2, 4 and 8 | The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: value at observation minus value at baseline. Positive change from baseline indicated improvement. |
| Percentage of Participants Who Achieve ≥10 mm Schirmer Test Value Without Anesthesia for Study Eye | Week 1, 2, 4 and 8 | The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. |
| Number of Participants Who Increase of ≥10 mm From Baseline in Schirmer Test Value Without Anesthesia for Study Eye | Week 1, 2, 4 and 8 | The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. |
| Changes in the Ocular Comfort Index (OCI) Total Score From Baseline | Baseline, Week 1, 2, 4 and 8 | The OCI is a validated instrument developed to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point rating scale (0 \[Never\] to 6 \[Always\], or 0 \[Never had it\] to 6 \[Severe\]). Total score ranged from 0 (none) to 72 (severe symptoms). A higher score indicates more severe dry eye symptoms. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement. |
| Number of Participants Demonstrating at Least ≥3 Unit Decrease in Ocular Comfort Index (OCI) Total Score From Baseline | Week 1, 2, 4 and 8 | The OCI is a validated instrument developed to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point rating scale (0 \[Never\] to 6 \[Always\], or 0 \[Never had it\] to 6 \[Severe\]). Total score ranged from 0 (none) to 72 (severe symptoms). A higher score indicates more severe dry eye symptoms. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change = scores at observation minus score at baseline. Negative change from baseline indicated improvement. |
| Changes in the Ocular Surface Disease Index (OSDI) Total Score From Baseline | Baseline, Week 1, 2, 4 and 8 | The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 \[none of the time\] to 4 \[all of the time\]. The total OSDI score was then calculated on the basis of the following formula: OSDI=\[(sum of scores for all questions answered) × 100\]/\[(total number of questions answered) × 4\]. The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement. |
| Changes in Corneal Staining Scores for Study Eye From Baseline | Baseline, Week 1, 2 and 4 | Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale:0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement. |
| Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Vision-Related Function | Baseline, Week 1, 2, 4 and 8 | The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 \[none of the time\] to 4 \[all of the time\]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=\[(sum of scores for questions 4 to 9 answered) × 100\]/\[(total number of questions 4 to 9 answered) × 4\]. Thus, the OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement. |
| Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Environmental Triggers | Baseline, Week 1, 2, 4 and 8 | The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 \[none of the time\] to 4 \[all of the time\]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=\[(sum of scores for questions 10 to 12 answered) × 100\]/\[(total number of questions 10 to 12 answered) × 4\]. The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement. |
| Percentage of Participants Demonstrating ≥10 Unit Decrease in Ocular Surface Disease Index (OSDI) Total Score From Baseline | Week 1, 2, 4 and 8 | The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 \[none of the time\] to 4 \[all of the time\]. The total OSDI score was then calculated on the basis of the following formula: OSDI=\[(sum of scores for all questions answered) × 100\]/\[(total number of questions answered) × 4\]. The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. |
| Number of Participants Evaluable for Time to Achievement of 100% Clearing of Corneal Staining for Study Eye | Week 8 | Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale. The maximum possible staining score is 15, higher score indicated greater staining. 100% Clearing of Corneal Staining means corneal staining score = 0. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. |
| Number of Participants Evaluable for Time to Achievement of ≥10 mm Schirmer Wetting Score Without Anesthesia for Study Eye | Week 8 | The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. |
| Number of Participants Evaluable for Time to Achievement of ≥3 Unit Decrease in OCI Scores | Week 8 | The OCI is a validated instrument developed to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point rating scale (0 \[Never\] to 6 \[Always\], or 0 \[Never had it\] to 6 \[Severe\]). Negative change from baseline indicated improvement. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. |
| Number of Participants With Ocular Adverse Events (AEs)by Severity | 8 weeks | Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Ocular AEs are the events which are localized in the ocular region. Participants with multiple occurrences of an AE within a category were counted once within the category. |
| Number of Participants With Nonocular Adverse Events (AEs) by Severity | 8 weeks | Counts of participants who had treatment-emergent nonocular AEs, defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category. |
| Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | 8 weeks | Ocular tolerability was assessed for the 5 symptoms (burning sensation, blurred vision, ocular discomfort, pain, tearing), based on a 4-point severity scale (none, minor, moderate, and severe). Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. |
| Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Ocular Symptoms | Baseline, Week 1, 2, 4 and 8 | The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 \[the none of time\] to 4 \[all of the time\]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=\[(sum of scores for questions 1 to 3 answered) × 100\]/\[(total number of questions 1 to 3 answered) × 4\]. The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Tissue Inhibitor of Metalloproteinase 1 (TIMP-1) | Baseline, Week 4 and 8 | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. |
| Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Epidermal Growth Factor | Baseline, Week 4 and 8 | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. |
| Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Albumin | Baseline, Week 4 and 8 | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. |
| Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 5AC | Baseline, Week 4 and 8 | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. |
| Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Human Leukocyte Antigen-DR Antibody Bound Per Cell for Study Eye | Baseline, Week 4 and 8 | The average level of HLA-DR expression per cell was reported as HLA-DR antibody bound per cell (ABC). Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change = value at observation minus value at baseline. |
| Change in the Biomarker in Tear Fluid for Study Eye From Baseline - Mucin 16 Carbohydrate Antigen 125 | Baseline, Week 4 and 8 | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. |
| Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 1 | Baseline, Week 4 and 8 | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. |
| Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Lipocalin 1 | Baseline, Week 4 and 8 | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. |
| Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Total Protein | Baseline, Week 4 and 8 | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. |
| Number of Participants Evaluated for Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 4 | Week 4 and 8 | Number of analyzed with sufficient quantity for analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. |
| Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Percentage of Human Leukocyte Antigen (HLA)-DR Positive for Study Eye | Baseline, Week 4 and 8 | Percentage of conjunctival epithelial cells that were positive with HLA-DR expression was calculated as HLA-DR Positive. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. |
| Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Apolipoprotein C-3 | Baseline, Week 4 and 8 | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. |
| Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-18 | Baseline, Week 4 and 8 | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. |
| Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-6 | Baseline, Week 4 and 8 | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. |
| Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-7 | Baseline, Week 4 and 8 | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. |
| Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-8 | Baseline, Week 4 and 8 | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. |
| Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Monocyte Chemotactic Protein 1 | Baseline, Week 4 and 8 | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. |
| Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-12 P40/P35 Heterodimer (IL-12P70) | Baseline, Week 4 and 8 | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. |
| Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Beta | Baseline, Week 4 and 8 | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. |
| Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Receptor Antagonist | Baseline, Week 4 and 8 | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. |
| Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-23 | Baseline, Week 4 and 8 | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. |
| Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-3 | Baseline, Week 4 and 8 | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. |
| Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-9 | Baseline, Week 4 and 8 | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. |
| Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Vascular Endothelial Growth Factor | Baseline, Week 4 and 8 | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. |
| Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Alpha-1 Antitrypsin | Baseline, Week 4 and 8 | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. |
| Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-17A | Baseline, Week 4 and 8 | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. |
| Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-X-C Motif) Ligand 10 (CXCL10) (Alias Gamma-Interferon Inducible Protein 10: IP10) | Baseline, Week 4 and 8 | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. |
| Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-X-C Motif) Ligand 9 (CXCL9) (Alias Monokine Induced by Gamma Interferon: MIG) | Baseline, Week 4 and 8 | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. |
| Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine ( C-C Motif) Ligand 20 (CCL20) (Alias Macrophage Inflammatory Protein 3 Alpha: MIP3A) | Baseline, Week 4 and 8 | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. |
| Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-C Motif) Ligand 5 (CCL5) (Alias Regulated on Activation, Normal T Cell Expressed, and Secreted: RANTES) | Baseline, Week 4 and 8 | Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline. |
Countries
Japan, South Korea
Participant flow
Pre-assignment details
In this study, during the 2-week run-in period, enrolled participants were administered artificial tears 4 times daily after signing informed consent.
Participants by arm
| Arm | Count |
|---|---|
| CP-690,550 Eye Drops Vehicle Group in Japan At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | 41 |
| CP-690,550 Eye Drops 0.001% Group in Japan At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | 42 |
| CP-690,550 Eye Drops 0.003% Group in Japan At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | 41 |
| CP-690,550 Eye Drops 0.005% Group in Japan At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | 40 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. | 39 |
| CP-690,550 Eye Drops Vehicle Group in Korea At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | 21 |
| CP-690,550 Eye Drops 0.001% Group in Korea At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | 19 |
| CP-690,550 Eye Drops 0.003% Group in Korea At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | 21 |
| CP-690,550 Eye Drops 0.005% Group in Korea At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. | 21 |
| Total | 285 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 |
|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 2 | 0 | 0 | 1 | 0 | 1 | 0 |
| Overall Study | could not visit the clinic | 0 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Lack of Efficacy | 0 | 1 | 1 | 2 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | noncompliance with study drug taken | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Pregnancy | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | CP-690,550 Eye Drops Vehicle Group in Korea | CP-690,550 Eye Drops 0.001% Group in Korea | CP-690,550 Eye Drops 0.003% Group in Korea | CP-690,550 Eye Drops 0.005% Group in Korea | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized >=65 years | 18 participants | 14 participants | 18 participants | 13 participants | 14 participants | 6 participants | 3 participants | 1 participants | 8 participants | 95 participants |
| Age, Customized Between 18 and 44 years | 14 participants | 14 participants | 11 participants | 11 participants | 11 participants | 5 participants | 8 participants | 7 participants | 3 participants | 84 participants |
| Age, Customized Between 45 and 64 years | 9 participants | 14 participants | 12 participants | 16 participants | 14 participants | 10 participants | 8 participants | 13 participants | 10 participants | 106 participants |
| Sex: Female, Male Female | 32 Participants | 39 Participants | 37 Participants | 33 Participants | 34 Participants | 20 Participants | 16 Participants | 20 Participants | 19 Participants | 250 Participants |
| Sex: Female, Male Male | 9 Participants | 3 Participants | 4 Participants | 7 Participants | 5 Participants | 1 Participants | 3 Participants | 1 Participants | 2 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 11 / 41 | 11 / 42 | 16 / 41 | 8 / 40 | 9 / 39 | 6 / 21 | 7 / 19 | 6 / 21 | 8 / 21 |
| serious Total, serious adverse events | 0 / 41 | 0 / 42 | 2 / 41 | 0 / 40 | 0 / 39 | 0 / 21 | 0 / 19 | 1 / 21 | 0 / 21 |
Outcome results
Primary
Changes in Corneal Staining Scores for Study Eye From Baseline at Week 8
Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale:0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
Time frame: Baseline, Week 8
Population: Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 Eye Drops Vehicle Group in Japan | Changes in Corneal Staining Scores for Study Eye From Baseline at Week 8 | -3.0 Units on a scale | Standard Deviation 2.1 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Changes in Corneal Staining Scores for Study Eye From Baseline at Week 8 | -3.0 Units on a scale | Standard Deviation 2.8 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Changes in Corneal Staining Scores for Study Eye From Baseline at Week 8 | -3.0 Units on a scale | Standard Deviation 2.5 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Changes in Corneal Staining Scores for Study Eye From Baseline at Week 8 | -3.1 Units on a scale | Standard Deviation 2.6 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Changes in Corneal Staining Scores for Study Eye From Baseline at Week 8 | -3.2 Units on a scale | Standard Deviation 2.4 |
| CP-690,550 Eye Drops Vehicle Group in Korea | Changes in Corneal Staining Scores for Study Eye From Baseline at Week 8 | -2.4 Units on a scale | Standard Deviation 2.4 |
| CP-690,550 Eye Drops 0.001% Group in Korea | Changes in Corneal Staining Scores for Study Eye From Baseline at Week 8 | -3.0 Units on a scale | Standard Deviation 2.7 |
| CP-690,550 Eye Drops 0.003% Group in Korea | Changes in Corneal Staining Scores for Study Eye From Baseline at Week 8 | -2.8 Units on a scale | Standard Deviation 1.9 |
| CP-690,550 Eye Drops 0.005% Group in Korea | Changes in Corneal Staining Scores for Study Eye From Baseline at Week 8 | -2.2 Units on a scale | Standard Deviation 2.5 |
Secondary
Changes in Conjunctival Staining Scores (Interpalpebral) for Study Eye From Baseline
Based on the Oxford grading system, the bulbar conjunctiva of each eye was divided into 2 different zones (nasal and temporal). The nasal and temporal bulbar conjunctival zones were each graded independently using a 6-point scale (0 \[Absent\] to 5 \[Severe\]). Total score ranged from 0 (Absent) to 10 (severe), higher score=higher damage to eyes due to dryness. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change = scores at observation minus score at baseline. Negative change from baseline indicated improvement.
Time frame: Baseline, Week 1, 2, 4 and 8
Population: Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 Eye Drops Vehicle Group in Japan | Changes in Conjunctival Staining Scores (Interpalpebral) for Study Eye From Baseline | Week 1 (n=41, 41, 40, 40, 39) | -0.8 Units on a scale | Standard Deviation 1.9 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Changes in Conjunctival Staining Scores (Interpalpebral) for Study Eye From Baseline | Week 2 (n=40, 41, 39, 40, 39) | -1.0 Units on a scale | Standard Deviation 2.2 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Changes in Conjunctival Staining Scores (Interpalpebral) for Study Eye From Baseline | Week 4 (n=41, 40, 35, 40, 38) | -1.2 Units on a scale | Standard Deviation 2.2 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Changes in Conjunctival Staining Scores (Interpalpebral) for Study Eye From Baseline | Week 8 (n=41, 41, 40, 40, 39, LOCF) | -1.0 Units on a scale | Standard Deviation 2.3 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Changes in Conjunctival Staining Scores (Interpalpebral) for Study Eye From Baseline | Week 1 (n=41, 41, 40, 40, 39) | -0.7 Units on a scale | Standard Deviation 1.8 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Changes in Conjunctival Staining Scores (Interpalpebral) for Study Eye From Baseline | Week 8 (n=41, 41, 40, 40, 39, LOCF) | -1.1 Units on a scale | Standard Deviation 2.1 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Changes in Conjunctival Staining Scores (Interpalpebral) for Study Eye From Baseline | Week 2 (n=40, 41, 39, 40, 39) | -0.8 Units on a scale | Standard Deviation 2 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Changes in Conjunctival Staining Scores (Interpalpebral) for Study Eye From Baseline | Week 4 (n=41, 40, 35, 40, 38) | -1.0 Units on a scale | Standard Deviation 1.7 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Changes in Conjunctival Staining Scores (Interpalpebral) for Study Eye From Baseline | Week 8 (n=41, 41, 40, 40, 39, LOCF) | -0.9 Units on a scale | Standard Deviation 1.4 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Changes in Conjunctival Staining Scores (Interpalpebral) for Study Eye From Baseline | Week 2 (n=40, 41, 39, 40, 39) | -0.7 Units on a scale | Standard Deviation 1.5 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Changes in Conjunctival Staining Scores (Interpalpebral) for Study Eye From Baseline | Week 4 (n=41, 40, 35, 40, 38) | -0.8 Units on a scale | Standard Deviation 1.5 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Changes in Conjunctival Staining Scores (Interpalpebral) for Study Eye From Baseline | Week 1 (n=41, 41, 40, 40, 39) | -0.6 Units on a scale | Standard Deviation 1.3 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Changes in Conjunctival Staining Scores (Interpalpebral) for Study Eye From Baseline | Week 1 (n=41, 41, 40, 40, 39) | -1.1 Units on a scale | Standard Deviation 1.7 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Changes in Conjunctival Staining Scores (Interpalpebral) for Study Eye From Baseline | Week 2 (n=40, 41, 39, 40, 39) | -1.7 Units on a scale | Standard Deviation 2.5 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Changes in Conjunctival Staining Scores (Interpalpebral) for Study Eye From Baseline | Week 8 (n=41, 41, 40, 40, 39, LOCF) | -2.0 Units on a scale | Standard Deviation 2.1 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Changes in Conjunctival Staining Scores (Interpalpebral) for Study Eye From Baseline | Week 4 (n=41, 40, 35, 40, 38) | -2.0 Units on a scale | Standard Deviation 2.4 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Changes in Conjunctival Staining Scores (Interpalpebral) for Study Eye From Baseline | Week 8 (n=41, 41, 40, 40, 39, LOCF) | -0.9 Units on a scale | Standard Deviation 1.8 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Changes in Conjunctival Staining Scores (Interpalpebral) for Study Eye From Baseline | Week 4 (n=41, 40, 35, 40, 38) | -1.1 Units on a scale | Standard Deviation 2.2 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Changes in Conjunctival Staining Scores (Interpalpebral) for Study Eye From Baseline | Week 2 (n=40, 41, 39, 40, 39) | -1.0 Units on a scale | Standard Deviation 2.1 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Changes in Conjunctival Staining Scores (Interpalpebral) for Study Eye From Baseline | Week 1 (n=41, 41, 40, 40, 39) | -0.6 Units on a scale | Standard Deviation 1.7 |
Secondary
Changes in Corneal Staining Scores for Study Eye From Baseline
Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale:0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
Time frame: Baseline, Week 1, 2 and 4
Population: Intent-to-treat population: Participants who received at least 1 dose of study treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 Eye Drops Vehicle Group in Japan | Changes in Corneal Staining Scores for Study Eye From Baseline | Week 1 | -2.1 Units on a scale | Standard Deviation 1.9 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Changes in Corneal Staining Scores for Study Eye From Baseline | Week 4 | -2.7 Units on a scale | Standard Deviation 2 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Changes in Corneal Staining Scores for Study Eye From Baseline | Week 2 | -2.4 Units on a scale | Standard Deviation 1.8 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Changes in Corneal Staining Scores for Study Eye From Baseline | Week 2 | -2.4 Units on a scale | Standard Deviation 2 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Changes in Corneal Staining Scores for Study Eye From Baseline | Week 1 | -1.9 Units on a scale | Standard Deviation 2.1 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Changes in Corneal Staining Scores for Study Eye From Baseline | Week 4 | -3.0 Units on a scale | Standard Deviation 2.7 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Changes in Corneal Staining Scores for Study Eye From Baseline | Week 2 | -3.2 Units on a scale | Standard Deviation 1.8 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Changes in Corneal Staining Scores for Study Eye From Baseline | Week 1 | -1.9 Units on a scale | Standard Deviation 2.1 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Changes in Corneal Staining Scores for Study Eye From Baseline | Week 4 | -3.2 Units on a scale | Standard Deviation 2.4 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Changes in Corneal Staining Scores for Study Eye From Baseline | Week 1 | -1.6 Units on a scale | Standard Deviation 2 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Changes in Corneal Staining Scores for Study Eye From Baseline | Week 4 | -3.3 Units on a scale | Standard Deviation 2.5 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Changes in Corneal Staining Scores for Study Eye From Baseline | Week 2 | -3.0 Units on a scale | Standard Deviation 2 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Changes in Corneal Staining Scores for Study Eye From Baseline | Week 2 | -2.8 Units on a scale | Standard Deviation 2.1 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Changes in Corneal Staining Scores for Study Eye From Baseline | Week 1 | -2.0 Units on a scale | Standard Deviation 2 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Changes in Corneal Staining Scores for Study Eye From Baseline | Week 4 | -2.6 Units on a scale | Standard Deviation 2.1 |
Secondary
Changes in Schirmer Test Values Without Anesthesia for Study Eye From Baseline
The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: value at observation minus value at baseline. Positive change from baseline indicated improvement.
Time frame: Baseline, Week 1, 2, 4 and 8
Population: Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 Eye Drops Vehicle Group in Japan | Changes in Schirmer Test Values Without Anesthesia for Study Eye From Baseline | Week 1 (n=41, 41, 40, 40, 39) | 0.78 Millimeters | Standard Deviation 6.07 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Changes in Schirmer Test Values Without Anesthesia for Study Eye From Baseline | Week 2 (n=40, 41, 39, 40, 39) | 0.28 Millimeters | Standard Deviation 2.77 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Changes in Schirmer Test Values Without Anesthesia for Study Eye From Baseline | Week 4 (n=41, 40, 35, 40, 38) | 0.30 Millimeters | Standard Deviation 3.39 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Changes in Schirmer Test Values Without Anesthesia for Study Eye From Baseline | Week 8 (n=41, 41, 40, 40, 39, LOCF) | 0.91 Millimeters | Standard Deviation 5.43 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Changes in Schirmer Test Values Without Anesthesia for Study Eye From Baseline | Week 1 (n=41, 41, 40, 40, 39) | 0.34 Millimeters | Standard Deviation 3.1 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Changes in Schirmer Test Values Without Anesthesia for Study Eye From Baseline | Week 8 (n=41, 41, 40, 40, 39, LOCF) | 0.10 Millimeters | Standard Deviation 2.57 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Changes in Schirmer Test Values Without Anesthesia for Study Eye From Baseline | Week 2 (n=40, 41, 39, 40, 39) | 0.51 Millimeters | Standard Deviation 3.49 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Changes in Schirmer Test Values Without Anesthesia for Study Eye From Baseline | Week 4 (n=41, 40, 35, 40, 38) | 0.49 Millimeters | Standard Deviation 2.54 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Changes in Schirmer Test Values Without Anesthesia for Study Eye From Baseline | Week 8 (n=41, 41, 40, 40, 39, LOCF) | 0.74 Millimeters | Standard Deviation 2.46 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Changes in Schirmer Test Values Without Anesthesia for Study Eye From Baseline | Week 2 (n=40, 41, 39, 40, 39) | 0.28 Millimeters | Standard Deviation 2.26 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Changes in Schirmer Test Values Without Anesthesia for Study Eye From Baseline | Week 4 (n=41, 40, 35, 40, 38) | 0.13 Millimeters | Standard Deviation 2.28 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Changes in Schirmer Test Values Without Anesthesia for Study Eye From Baseline | Week 1 (n=41, 41, 40, 40, 39) | 0.01 Millimeters | Standard Deviation 2.16 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Changes in Schirmer Test Values Without Anesthesia for Study Eye From Baseline | Week 1 (n=41, 41, 40, 40, 39) | 0.08 Millimeters | Standard Deviation 3.01 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Changes in Schirmer Test Values Without Anesthesia for Study Eye From Baseline | Week 2 (n=40, 41, 39, 40, 39) | 0.93 Millimeters | Standard Deviation 3.56 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Changes in Schirmer Test Values Without Anesthesia for Study Eye From Baseline | Week 8 (n=41, 41, 40, 40, 39, LOCF) | 0.26 Millimeters | Standard Deviation 2.93 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Changes in Schirmer Test Values Without Anesthesia for Study Eye From Baseline | Week 4 (n=41, 40, 35, 40, 38) | 1.13 Millimeters | Standard Deviation 4.23 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Changes in Schirmer Test Values Without Anesthesia for Study Eye From Baseline | Week 8 (n=41, 41, 40, 40, 39, LOCF) | 1.53 Millimeters | Standard Deviation 5.32 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Changes in Schirmer Test Values Without Anesthesia for Study Eye From Baseline | Week 4 (n=41, 40, 35, 40, 38) | 0.64 Millimeters | Standard Deviation 3.38 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Changes in Schirmer Test Values Without Anesthesia for Study Eye From Baseline | Week 2 (n=40, 41, 39, 40, 39) | 1.04 Millimeters | Standard Deviation 4.53 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Changes in Schirmer Test Values Without Anesthesia for Study Eye From Baseline | Week 1 (n=41, 41, 40, 40, 39) | 0.71 Millimeters | Standard Deviation 3.99 |
Secondary
Changes in Tear Break Up Time (TBUT) for Study Eye From Baseline
TBUT is the interval between the last complete blink and the first appearance of a dry spot, or disruption in the tear film. Using a stopwatch, the time between last complete blink and first appearance of dry spot was recorded. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: value at observation minus value at baseline. Positive change from baseline indicated improvement.
Time frame: Baseline, Week 1, 2, 4 and 8
Population: Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 Eye Drops Vehicle Group in Japan | Changes in Tear Break Up Time (TBUT) for Study Eye From Baseline | Week 1 (n=41, 41, 40, 40, 39) | 0.04 Seconds | Standard Deviation 0.83 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Changes in Tear Break Up Time (TBUT) for Study Eye From Baseline | Week 2 (n=40, 41, 39, 40, 39) | 0.09 Seconds | Standard Deviation 0.95 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Changes in Tear Break Up Time (TBUT) for Study Eye From Baseline | Week 4 (n=41, 40, 35, 40, 38) | -0.01 Seconds | Standard Deviation 0.92 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Changes in Tear Break Up Time (TBUT) for Study Eye From Baseline | Week 8 (n=41, 41, 40, 40, 39, LOCF) | -0.06 Seconds | Standard Deviation 1.13 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Changes in Tear Break Up Time (TBUT) for Study Eye From Baseline | Week 1 (n=41, 41, 40, 40, 39) | 0.43 Seconds | Standard Deviation 3.61 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Changes in Tear Break Up Time (TBUT) for Study Eye From Baseline | Week 8 (n=41, 41, 40, 40, 39, LOCF) | -0.25 Seconds | Standard Deviation 2.17 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Changes in Tear Break Up Time (TBUT) for Study Eye From Baseline | Week 2 (n=40, 41, 39, 40, 39) | -0.31 Seconds | Standard Deviation 2.84 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Changes in Tear Break Up Time (TBUT) for Study Eye From Baseline | Week 4 (n=41, 40, 35, 40, 38) | 0.20 Seconds | Standard Deviation 3.61 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Changes in Tear Break Up Time (TBUT) for Study Eye From Baseline | Week 8 (n=41, 41, 40, 40, 39, LOCF) | 0.27 Seconds | Standard Deviation 0.77 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Changes in Tear Break Up Time (TBUT) for Study Eye From Baseline | Week 2 (n=40, 41, 39, 40, 39) | 0.26 Seconds | Standard Deviation 0.84 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Changes in Tear Break Up Time (TBUT) for Study Eye From Baseline | Week 4 (n=41, 40, 35, 40, 38) | 0.31 Seconds | Standard Deviation 0.62 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Changes in Tear Break Up Time (TBUT) for Study Eye From Baseline | Week 1 (n=41, 41, 40, 40, 39) | 0.19 Seconds | Standard Deviation 0.76 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Changes in Tear Break Up Time (TBUT) for Study Eye From Baseline | Week 1 (n=41, 41, 40, 40, 39) | 0.22 Seconds | Standard Deviation 1.95 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Changes in Tear Break Up Time (TBUT) for Study Eye From Baseline | Week 2 (n=40, 41, 39, 40, 39) | 0.04 Seconds | Standard Deviation 1.54 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Changes in Tear Break Up Time (TBUT) for Study Eye From Baseline | Week 8 (n=41, 41, 40, 40, 39, LOCF) | 1.00 Seconds | Standard Deviation 3.56 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Changes in Tear Break Up Time (TBUT) for Study Eye From Baseline | Week 4 (n=41, 40, 35, 40, 38) | 0.46 Seconds | Standard Deviation 1.87 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Changes in Tear Break Up Time (TBUT) for Study Eye From Baseline | Week 8 (n=41, 41, 40, 40, 39, LOCF) | 0.76 Seconds | Standard Deviation 1.38 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Changes in Tear Break Up Time (TBUT) for Study Eye From Baseline | Week 4 (n=41, 40, 35, 40, 38) | 0.53 Seconds | Standard Deviation 1.42 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Changes in Tear Break Up Time (TBUT) for Study Eye From Baseline | Week 2 (n=40, 41, 39, 40, 39) | 1.72 Seconds | Standard Deviation 8.53 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Changes in Tear Break Up Time (TBUT) for Study Eye From Baseline | Week 1 (n=41, 41, 40, 40, 39) | 0.43 Seconds | Standard Deviation 3.22 |
Secondary
Changes in the Ocular Comfort Index (OCI) Total Score From Baseline
The OCI is a validated instrument developed to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point rating scale (0 \[Never\] to 6 \[Always\], or 0 \[Never had it\] to 6 \[Severe\]). Total score ranged from 0 (none) to 72 (severe symptoms). A higher score indicates more severe dry eye symptoms. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
Time frame: Baseline, Week 1, 2, 4 and 8
Population: Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 Eye Drops Vehicle Group in Japan | Changes in the Ocular Comfort Index (OCI) Total Score From Baseline | Week 1 (n=41, 41, 40, 40, 39) | -1.94 Units on a scale | Standard Deviation 5.2 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Changes in the Ocular Comfort Index (OCI) Total Score From Baseline | Week 8 (n=41, 41, 40, 40, 39, LOCF) | -5.09 Units on a scale | Standard Deviation 7.74 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Changes in the Ocular Comfort Index (OCI) Total Score From Baseline | Week 4 (n=41, 40, 35, 40, 38) | -3.27 Units on a scale | Standard Deviation 6.95 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Changes in the Ocular Comfort Index (OCI) Total Score From Baseline | Week 2 (n=40, 41, 40, 40, 39) | -4.16 Units on a scale | Standard Deviation 9 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Changes in the Ocular Comfort Index (OCI) Total Score From Baseline | Week 8 (n=41, 41, 40, 40, 39, LOCF) | -4.98 Units on a scale | Standard Deviation 7.67 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Changes in the Ocular Comfort Index (OCI) Total Score From Baseline | Week 2 (n=40, 41, 40, 40, 39) | -4.76 Units on a scale | Standard Deviation 7.63 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Changes in the Ocular Comfort Index (OCI) Total Score From Baseline | Week 4 (n=41, 40, 35, 40, 38) | -4.20 Units on a scale | Standard Deviation 7.08 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Changes in the Ocular Comfort Index (OCI) Total Score From Baseline | Week 1 (n=41, 41, 40, 40, 39) | -2.00 Units on a scale | Standard Deviation 6.22 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Changes in the Ocular Comfort Index (OCI) Total Score From Baseline | Week 4 (n=41, 40, 35, 40, 38) | -5.77 Units on a scale | Standard Deviation 9.71 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Changes in the Ocular Comfort Index (OCI) Total Score From Baseline | Week 1 (n=41, 41, 40, 40, 39) | -2.13 Units on a scale | Standard Deviation 7.92 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Changes in the Ocular Comfort Index (OCI) Total Score From Baseline | Week 8 (n=41, 41, 40, 40, 39, LOCF) | -3.90 Units on a scale | Standard Deviation 9.3 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Changes in the Ocular Comfort Index (OCI) Total Score From Baseline | Week 2 (n=40, 41, 40, 40, 39) | -3.80 Units on a scale | Standard Deviation 8.77 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Changes in the Ocular Comfort Index (OCI) Total Score From Baseline | Week 4 (n=41, 40, 35, 40, 38) | -5.74 Units on a scale | Standard Deviation 7.26 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Changes in the Ocular Comfort Index (OCI) Total Score From Baseline | Week 2 (n=40, 41, 40, 40, 39) | -5.88 Units on a scale | Standard Deviation 6.98 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Changes in the Ocular Comfort Index (OCI) Total Score From Baseline | Week 1 (n=41, 41, 40, 40, 39) | -4.17 Units on a scale | Standard Deviation 6.86 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Changes in the Ocular Comfort Index (OCI) Total Score From Baseline | Week 8 (n=41, 41, 40, 40, 39, LOCF) | -6.87 Units on a scale | Standard Deviation 8.59 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Changes in the Ocular Comfort Index (OCI) Total Score From Baseline | Week 8 (n=41, 41, 40, 40, 39, LOCF) | -4.22 Units on a scale | Standard Deviation 9.53 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Changes in the Ocular Comfort Index (OCI) Total Score From Baseline | Week 1 (n=41, 41, 40, 40, 39) | -3.14 Units on a scale | Standard Deviation 7.88 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Changes in the Ocular Comfort Index (OCI) Total Score From Baseline | Week 2 (n=40, 41, 40, 40, 39) | -3.40 Units on a scale | Standard Deviation 6.12 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Changes in the Ocular Comfort Index (OCI) Total Score From Baseline | Week 4 (n=41, 40, 35, 40, 38) | -3.58 Units on a scale | Standard Deviation 9.85 |
Secondary
Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Environmental Triggers
The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 \[none of the time\] to 4 \[all of the time\]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=\[(sum of scores for questions 10 to 12 answered) × 100\]/\[(total number of questions 10 to 12 answered) × 4\]. The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
Time frame: Baseline, Week 1, 2, 4 and 8
Population: Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 Eye Drops Vehicle Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Environmental Triggers | Week 1 (n=38, 37, 40, 39, 35) | 1.21 Units on a scale | Standard Deviation 22.11 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Environmental Triggers | Week 2 (n=37, 37, 39, 37, 37) | -6.53 Units on a scale | Standard Deviation 20.43 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Environmental Triggers | Week 4 (n=38, 37, 35, 37, 36) | -6.14 Units on a scale | Standard Deviation 23.72 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Environmental Triggers | Week 8 (n=38, 37, 40, 39, 38, LOCF) | -7.13 Units on a scale | Standard Deviation 22.92 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Environmental Triggers | Week 1 (n=38, 37, 40, 39, 35) | -4.28 Units on a scale | Standard Deviation 23.66 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Environmental Triggers | Week 8 (n=38, 37, 40, 39, 38, LOCF) | -4.05 Units on a scale | Standard Deviation 34.11 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Environmental Triggers | Week 2 (n=37, 37, 39, 37, 37) | -7.21 Units on a scale | Standard Deviation 25.43 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Environmental Triggers | Week 4 (n=38, 37, 35, 37, 36) | -3.15 Units on a scale | Standard Deviation 30.23 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Environmental Triggers | Week 8 (n=38, 37, 40, 39, 38, LOCF) | 3.02 Units on a scale | Standard Deviation 31.76 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Environmental Triggers | Week 2 (n=37, 37, 39, 37, 37) | -6.20 Units on a scale | Standard Deviation 22.25 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Environmental Triggers | Week 4 (n=38, 37, 35, 37, 36) | -2.14 Units on a scale | Standard Deviation 24.88 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Environmental Triggers | Week 1 (n=38, 37, 40, 39, 35) | 0.31 Units on a scale | Standard Deviation 22.2 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Environmental Triggers | Week 1 (n=38, 37, 40, 39, 35) | -3.53 Units on a scale | Standard Deviation 15.52 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Environmental Triggers | Week 2 (n=37, 37, 39, 37, 37) | -8.56 Units on a scale | Standard Deviation 18.66 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Environmental Triggers | Week 8 (n=38, 37, 40, 39, 38, LOCF) | -8.44 Units on a scale | Standard Deviation 27.83 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Environmental Triggers | Week 4 (n=38, 37, 35, 37, 36) | -9.57 Units on a scale | Standard Deviation 22.78 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Environmental Triggers | Week 8 (n=38, 37, 40, 39, 38, LOCF) | -4.82 Units on a scale | Standard Deviation 24.46 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Environmental Triggers | Week 4 (n=38, 37, 35, 37, 36) | -4.17 Units on a scale | Standard Deviation 23.44 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Environmental Triggers | Week 2 (n=37, 37, 39, 37, 37) | -4.28 Units on a scale | Standard Deviation 21.48 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Environmental Triggers | Week 1 (n=38, 37, 40, 39, 35) | -4.88 Units on a scale | Standard Deviation 20.32 |
Secondary
Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Ocular Symptoms
The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 \[the none of time\] to 4 \[all of the time\]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=\[(sum of scores for questions 1 to 3 answered) × 100\]/\[(total number of questions 1 to 3 answered) × 4\]. The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
Time frame: Baseline, Week 1, 2, 4 and 8
Population: Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 Eye Drops Vehicle Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Ocular Symptoms | Week 2 (n=40, 41, 40, 40, 39) | -4.17 Units on a scale | Standard Deviation 19.61 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Ocular Symptoms | Week 1 (n=41, 41, 40, 40, 39) | -0.81 Units on a scale | Standard Deviation 15.9 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Ocular Symptoms | Week 8 (n=41, 41, 40, 40, 39, LOCF) | -3.86 Units on a scale | Standard Deviation 19.01 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Ocular Symptoms | Week 4 (n=41, 40, 35, 40, 38) | -3.05 Units on a scale | Standard Deviation 18.89 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Ocular Symptoms | Week 1 (n=41, 41, 40, 40, 39) | -4.07 Units on a scale | Standard Deviation 13.83 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Ocular Symptoms | Week 2 (n=40, 41, 40, 40, 39) | -8.74 Units on a scale | Standard Deviation 18.06 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Ocular Symptoms | Week 4 (n=41, 40, 35, 40, 38) | -7.50 Units on a scale | Standard Deviation 19.59 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Ocular Symptoms | Week 8 (n=41, 41, 40, 40, 39, LOCF) | -7.72 Units on a scale | Standard Deviation 21.2 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Ocular Symptoms | Week 4 (n=41, 40, 35, 40, 38) | -6.19 Units on a scale | Standard Deviation 14.05 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Ocular Symptoms | Week 2 (n=40, 41, 40, 40, 39) | -3.75 Units on a scale | Standard Deviation 14.24 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Ocular Symptoms | Week 8 (n=41, 41, 40, 40, 39, LOCF) | -2.29 Units on a scale | Standard Deviation 17.29 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Ocular Symptoms | Week 1 (n=41, 41, 40, 40, 39) | -3.96 Units on a scale | Standard Deviation 13.74 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Ocular Symptoms | Week 2 (n=40, 41, 40, 40, 39) | -7.92 Units on a scale | Standard Deviation 16.01 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Ocular Symptoms | Week 1 (n=41, 41, 40, 40, 39) | -5.00 Units on a scale | Standard Deviation 12.77 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Ocular Symptoms | Week 8 (n=41, 41, 40, 40, 39, LOCF) | -6.04 Units on a scale | Standard Deviation 18.87 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Ocular Symptoms | Week 4 (n=41, 40, 35, 40, 38) | -5.42 Units on a scale | Standard Deviation 17.56 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Ocular Symptoms | Week 8 (n=41, 41, 40, 40, 39, LOCF) | -0.21 Units on a scale | Standard Deviation 15.59 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Ocular Symptoms | Week 1 (n=41, 41, 40, 40, 39) | -2.56 Units on a scale | Standard Deviation 14.7 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Ocular Symptoms | Week 4 (n=41, 40, 35, 40, 38) | -1.97 Units on a scale | Standard Deviation 15.43 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Ocular Symptoms | Week 2 (n=40, 41, 40, 40, 39) | -3.63 Units on a scale | Standard Deviation 13.49 |
Secondary
Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Vision-Related Function
The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 \[none of the time\] to 4 \[all of the time\]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=\[(sum of scores for questions 4 to 9 answered) × 100\]/\[(total number of questions 4 to 9 answered) × 4\]. Thus, the OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
Time frame: Baseline, Week 1, 2, 4 and 8
Population: Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 Eye Drops Vehicle Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Vision-Related Function | Week 2 (n=40, 41, 40, 40, 39) | -2.61 Units on a scale | Standard Deviation 16.88 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Vision-Related Function | Week 4 (n=41, 40, 35, 40, 38) | -1.70 Units on a scale | Standard Deviation 16.73 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Vision-Related Function | Week 8 (n=41, 41, 40, 40, 39, LOCF) | -2.56 Units on a scale | Standard Deviation 19.45 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Vision-Related Function | Week 1 (n=41, 41, 40, 40, 39) | -0.36 Units on a scale | Standard Deviation 18.75 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Vision-Related Function | Week 4 (n=41, 40, 35, 40, 38) | -6.52 Units on a scale | Standard Deviation 15.25 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Vision-Related Function | Week 1 (n=41, 41, 40, 40, 39) | -4.71 Units on a scale | Standard Deviation 14.31 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Vision-Related Function | Week 2 (n=40, 41, 40, 40, 39) | -5.83 Units on a scale | Standard Deviation 15.52 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Vision-Related Function | Week 8 (n=41, 41, 40, 40, 39, LOCF) | -8.29 Units on a scale | Standard Deviation 16.61 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Vision-Related Function | Week 8 (n=41, 41, 40, 40, 39, LOCF) | -2.07 Units on a scale | Standard Deviation 18.71 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Vision-Related Function | Week 4 (n=41, 40, 35, 40, 38) | -4.74 Units on a scale | Standard Deviation 17.82 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Vision-Related Function | Week 1 (n=41, 41, 40, 40, 39) | 0.40 Units on a scale | Standard Deviation 17.35 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Vision-Related Function | Week 2 (n=40, 41, 40, 40, 39) | -2.29 Units on a scale | Standard Deviation 20.91 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Vision-Related Function | Week 1 (n=41, 41, 40, 40, 39) | -6.55 Units on a scale | Standard Deviation 12.2 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Vision-Related Function | Week 2 (n=40, 41, 40, 40, 39) | -7.06 Units on a scale | Standard Deviation 11.87 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Vision-Related Function | Week 4 (n=41, 40, 35, 40, 38) | -4.29 Units on a scale | Standard Deviation 14.04 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Vision-Related Function | Week 8 (n=41, 41, 40, 40, 39, LOCF) | -4.75 Units on a scale | Standard Deviation 12.49 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Vision-Related Function | Week 2 (n=40, 41, 40, 40, 39) | -2.57 Units on a scale | Standard Deviation 14.48 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Vision-Related Function | Week 1 (n=41, 41, 40, 40, 39) | -3.33 Units on a scale | Standard Deviation 13.41 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Vision-Related Function | Week 8 (n=41, 41, 40, 40, 39, LOCF) | -3.81 Units on a scale | Standard Deviation 17.46 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Vision-Related Function | Week 4 (n=41, 40, 35, 40, 38) | -2.69 Units on a scale | Standard Deviation 15.35 |
Secondary
Changes in the Ocular Surface Disease Index (OSDI) Total Score From Baseline
The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 \[none of the time\] to 4 \[all of the time\]. The total OSDI score was then calculated on the basis of the following formula: OSDI=\[(sum of scores for all questions answered) × 100\]/\[(total number of questions answered) × 4\]. The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
Time frame: Baseline, Week 1, 2, 4 and 8
Population: Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 Eye Drops Vehicle Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Total Score From Baseline | Week 1 (n=41, 41, 40, 40, 39) | -0.43 Units on a scale | Standard Deviation 12.33 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Total Score From Baseline | Week 2 (n=40, 41, 40, 40, 39) | -4.09 Units on a scale | Standard Deviation 13.73 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Total Score From Baseline | Week 4 (n=41, 40, 35, 40, 38) | -3.18 Units on a scale | Standard Deviation 13.77 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Total Score From Baseline | Week 8 (n=41, 41, 40, 40, 39, LOCF) | -3.88 Units on a scale | Standard Deviation 14.92 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Total Score From Baseline | Week 1 (n=41, 41, 40, 40, 39) | -3.87 Units on a scale | Standard Deviation 12.42 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Total Score From Baseline | Week 8 (n=41, 41, 40, 40, 39, LOCF) | -7.07 Units on a scale | Standard Deviation 17.88 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Total Score From Baseline | Week 2 (n=40, 41, 40, 40, 39) | -7.04 Units on a scale | Standard Deviation 12.98 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Total Score From Baseline | Week 4 (n=41, 40, 35, 40, 38) | -5.99 Units on a scale | Standard Deviation 15.78 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Total Score From Baseline | Week 8 (n=41, 41, 40, 40, 39, LOCF) | -0.37 Units on a scale | Standard Deviation 16.77 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Total Score From Baseline | Week 2 (n=40, 41, 40, 40, 39) | -3.13 Units on a scale | Standard Deviation 14.45 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Total Score From Baseline | Week 4 (n=41, 40, 35, 40, 38) | -4.48 Units on a scale | Standard Deviation 13.92 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Total Score From Baseline | Week 1 (n=41, 41, 40, 40, 39) | -0.67 Units on a scale | Standard Deviation 12.68 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Total Score From Baseline | Week 1 (n=41, 41, 40, 40, 39) | -5.00 Units on a scale | Standard Deviation 9.13 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Total Score From Baseline | Week 2 (n=40, 41, 40, 40, 39) | -6.77 Units on a scale | Standard Deviation 11.28 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Total Score From Baseline | Week 8 (n=41, 41, 40, 40, 39, LOCF) | -5.89 Units on a scale | Standard Deviation 14.98 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Total Score From Baseline | Week 4 (n=41, 40, 35, 40, 38) | -5.11 Units on a scale | Standard Deviation 14.03 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Total Score From Baseline | Week 8 (n=41, 41, 40, 40, 39, LOCF) | -2.68 Units on a scale | Standard Deviation 15.1 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Total Score From Baseline | Week 4 (n=41, 40, 35, 40, 38) | -2.56 Units on a scale | Standard Deviation 12.69 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Total Score From Baseline | Week 2 (n=40, 41, 40, 40, 39) | -2.89 Units on a scale | Standard Deviation 11.34 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Changes in the Ocular Surface Disease Index (OSDI) Total Score From Baseline | Week 1 (n=41, 41, 40, 40, 39) | -2.99 Units on a scale | Standard Deviation 10.27 |
Secondary
Number of Participants Demonstrating at Least ≥3 Unit Decrease in Ocular Comfort Index (OCI) Total Score From Baseline
The OCI is a validated instrument developed to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point rating scale (0 \[Never\] to 6 \[Always\], or 0 \[Never had it\] to 6 \[Severe\]). Total score ranged from 0 (none) to 72 (severe symptoms). A higher score indicates more severe dry eye symptoms. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change = scores at observation minus score at baseline. Negative change from baseline indicated improvement.
Time frame: Week 1, 2, 4 and 8
Population: Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 Eye Drops Vehicle Group in Japan | Number of Participants Demonstrating at Least ≥3 Unit Decrease in Ocular Comfort Index (OCI) Total Score From Baseline | Week 1 (n=41, 41, 40, 40, 39) | 17 Participants |
| CP-690,550 Eye Drops Vehicle Group in Japan | Number of Participants Demonstrating at Least ≥3 Unit Decrease in Ocular Comfort Index (OCI) Total Score From Baseline | Week 2 (n=40, 41, 40, 40, 39) | 19 Participants |
| CP-690,550 Eye Drops Vehicle Group in Japan | Number of Participants Demonstrating at Least ≥3 Unit Decrease in Ocular Comfort Index (OCI) Total Score From Baseline | Week 4 (n=41, 40, 35, 40, 38) | 23 Participants |
| CP-690,550 Eye Drops Vehicle Group in Japan | Number of Participants Demonstrating at Least ≥3 Unit Decrease in Ocular Comfort Index (OCI) Total Score From Baseline | Week 8 (n=41, 41, 40, 40, 39, LOCF) | 25 Participants |
| CP-690,550 Eye Drops 0.001% Group in Japan | Number of Participants Demonstrating at Least ≥3 Unit Decrease in Ocular Comfort Index (OCI) Total Score From Baseline | Week 1 (n=41, 41, 40, 40, 39) | 15 Participants |
| CP-690,550 Eye Drops 0.001% Group in Japan | Number of Participants Demonstrating at Least ≥3 Unit Decrease in Ocular Comfort Index (OCI) Total Score From Baseline | Week 8 (n=41, 41, 40, 40, 39, LOCF) | 26 Participants |
| CP-690,550 Eye Drops 0.001% Group in Japan | Number of Participants Demonstrating at Least ≥3 Unit Decrease in Ocular Comfort Index (OCI) Total Score From Baseline | Week 2 (n=40, 41, 40, 40, 39) | 21 Participants |
| CP-690,550 Eye Drops 0.001% Group in Japan | Number of Participants Demonstrating at Least ≥3 Unit Decrease in Ocular Comfort Index (OCI) Total Score From Baseline | Week 4 (n=41, 40, 35, 40, 38) | 23 Participants |
| CP-690,550 Eye Drops 0.003% Group in Japan | Number of Participants Demonstrating at Least ≥3 Unit Decrease in Ocular Comfort Index (OCI) Total Score From Baseline | Week 8 (n=41, 41, 40, 40, 39, LOCF) | 22 Participants |
| CP-690,550 Eye Drops 0.003% Group in Japan | Number of Participants Demonstrating at Least ≥3 Unit Decrease in Ocular Comfort Index (OCI) Total Score From Baseline | Week 2 (n=40, 41, 40, 40, 39) | 19 Participants |
| CP-690,550 Eye Drops 0.003% Group in Japan | Number of Participants Demonstrating at Least ≥3 Unit Decrease in Ocular Comfort Index (OCI) Total Score From Baseline | Week 4 (n=41, 40, 35, 40, 38) | 21 Participants |
| CP-690,550 Eye Drops 0.003% Group in Japan | Number of Participants Demonstrating at Least ≥3 Unit Decrease in Ocular Comfort Index (OCI) Total Score From Baseline | Week 1 (n=41, 41, 40, 40, 39) | 13 Participants |
| CP-690,550 Eye Drops 0.005% Group in Japan | Number of Participants Demonstrating at Least ≥3 Unit Decrease in Ocular Comfort Index (OCI) Total Score From Baseline | Week 1 (n=41, 41, 40, 40, 39) | 21 Participants |
| CP-690,550 Eye Drops 0.005% Group in Japan | Number of Participants Demonstrating at Least ≥3 Unit Decrease in Ocular Comfort Index (OCI) Total Score From Baseline | Week 2 (n=40, 41, 40, 40, 39) | 28 Participants |
| CP-690,550 Eye Drops 0.005% Group in Japan | Number of Participants Demonstrating at Least ≥3 Unit Decrease in Ocular Comfort Index (OCI) Total Score From Baseline | Week 8 (n=41, 41, 40, 40, 39, LOCF) | 26 Participants |
| CP-690,550 Eye Drops 0.005% Group in Japan | Number of Participants Demonstrating at Least ≥3 Unit Decrease in Ocular Comfort Index (OCI) Total Score From Baseline | Week 4 (n=41, 40, 35, 40, 38) | 26 Participants |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Number of Participants Demonstrating at Least ≥3 Unit Decrease in Ocular Comfort Index (OCI) Total Score From Baseline | Week 8 (n=41, 41, 40, 40, 39, LOCF) | 16 Participants |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Number of Participants Demonstrating at Least ≥3 Unit Decrease in Ocular Comfort Index (OCI) Total Score From Baseline | Week 4 (n=41, 40, 35, 40, 38) | 16 Participants |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Number of Participants Demonstrating at Least ≥3 Unit Decrease in Ocular Comfort Index (OCI) Total Score From Baseline | Week 2 (n=40, 41, 40, 40, 39) | 20 Participants |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Number of Participants Demonstrating at Least ≥3 Unit Decrease in Ocular Comfort Index (OCI) Total Score From Baseline | Week 1 (n=41, 41, 40, 40, 39) | 16 Participants |
Secondary
Number of Participants Evaluable for Time to Achievement of 100% Clearing of Corneal Staining for Study Eye
Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale. The maximum possible staining score is 15, higher score indicated greater staining. 100% Clearing of Corneal Staining means corneal staining score = 0. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Time frame: Week 8
Population: Intent-to-treat population: Participants who received at least 1 dose of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CP-690,550 Eye Drops Vehicle Group in Japan | Number of Participants Evaluable for Time to Achievement of 100% Clearing of Corneal Staining for Study Eye | 8 Participants |
| CP-690,550 Eye Drops 0.001% Group in Japan | Number of Participants Evaluable for Time to Achievement of 100% Clearing of Corneal Staining for Study Eye | 4 Participants |
| CP-690,550 Eye Drops 0.003% Group in Japan | Number of Participants Evaluable for Time to Achievement of 100% Clearing of Corneal Staining for Study Eye | 6 Participants |
| CP-690,550 Eye Drops 0.005% Group in Japan | Number of Participants Evaluable for Time to Achievement of 100% Clearing of Corneal Staining for Study Eye | 5 Participants |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Number of Participants Evaluable for Time to Achievement of 100% Clearing of Corneal Staining for Study Eye | 1 Participants |
Secondary
Number of Participants Evaluable for Time to Achievement of ≥10 mm Schirmer Wetting Score Without Anesthesia for Study Eye
The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Time frame: Week 8
Population: Intent-to-treat population: Participants who received at least 1 dose of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CP-690,550 Eye Drops Vehicle Group in Japan | Number of Participants Evaluable for Time to Achievement of ≥10 mm Schirmer Wetting Score Without Anesthesia for Study Eye | 8 Participants |
| CP-690,550 Eye Drops 0.001% Group in Japan | Number of Participants Evaluable for Time to Achievement of ≥10 mm Schirmer Wetting Score Without Anesthesia for Study Eye | 6 Participants |
| CP-690,550 Eye Drops 0.003% Group in Japan | Number of Participants Evaluable for Time to Achievement of ≥10 mm Schirmer Wetting Score Without Anesthesia for Study Eye | 2 Participants |
| CP-690,550 Eye Drops 0.005% Group in Japan | Number of Participants Evaluable for Time to Achievement of ≥10 mm Schirmer Wetting Score Without Anesthesia for Study Eye | 4 Participants |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Number of Participants Evaluable for Time to Achievement of ≥10 mm Schirmer Wetting Score Without Anesthesia for Study Eye | 7 Participants |
Secondary
Number of Participants Evaluable for Time to Achievement of ≥3 Unit Decrease in OCI Scores
The OCI is a validated instrument developed to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point rating scale (0 \[Never\] to 6 \[Always\], or 0 \[Never had it\] to 6 \[Severe\]). Negative change from baseline indicated improvement. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Time frame: Week 8
Population: Intent-to-treat population: Participants who received at least 1 dose of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CP-690,550 Eye Drops Vehicle Group in Japan | Number of Participants Evaluable for Time to Achievement of ≥3 Unit Decrease in OCI Scores | 31 Participants |
| CP-690,550 Eye Drops 0.001% Group in Japan | Number of Participants Evaluable for Time to Achievement of ≥3 Unit Decrease in OCI Scores | 29 Participants |
| CP-690,550 Eye Drops 0.003% Group in Japan | Number of Participants Evaluable for Time to Achievement of ≥3 Unit Decrease in OCI Scores | 30 Participants |
| CP-690,550 Eye Drops 0.005% Group in Japan | Number of Participants Evaluable for Time to Achievement of ≥3 Unit Decrease in OCI Scores | 35 Participants |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Number of Participants Evaluable for Time to Achievement of ≥3 Unit Decrease in OCI Scores | 28 Participants |
Secondary
Number of Participants Who Increase of ≥10 mm From Baseline in Schirmer Test Value Without Anesthesia for Study Eye
The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Time frame: Week 1, 2, 4 and 8
Population: Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 Eye Drops Vehicle Group in Japan | Number of Participants Who Increase of ≥10 mm From Baseline in Schirmer Test Value Without Anesthesia for Study Eye | Week 2 (n=40, 41, 39, 40, 39) | 0 Participants |
| CP-690,550 Eye Drops Vehicle Group in Japan | Number of Participants Who Increase of ≥10 mm From Baseline in Schirmer Test Value Without Anesthesia for Study Eye | Week 1 (n=41, 41, 40, 40, 39) | 2 Participants |
| CP-690,550 Eye Drops Vehicle Group in Japan | Number of Participants Who Increase of ≥10 mm From Baseline in Schirmer Test Value Without Anesthesia for Study Eye | Week 4 (n=41, 40, 35, 40, 38) | 1 Participants |
| CP-690,550 Eye Drops Vehicle Group in Japan | Number of Participants Who Increase of ≥10 mm From Baseline in Schirmer Test Value Without Anesthesia for Study Eye | Week 8 (n=41, 41, 40, 40, 39, LOCF) | 3 Participants |
| CP-690,550 Eye Drops 0.001% Group in Japan | Number of Participants Who Increase of ≥10 mm From Baseline in Schirmer Test Value Without Anesthesia for Study Eye | Week 8 (n=41, 41, 40, 40, 39, LOCF) | 0 Participants |
| CP-690,550 Eye Drops 0.001% Group in Japan | Number of Participants Who Increase of ≥10 mm From Baseline in Schirmer Test Value Without Anesthesia for Study Eye | Week 4 (n=41, 40, 35, 40, 38) | 0 Participants |
| CP-690,550 Eye Drops 0.001% Group in Japan | Number of Participants Who Increase of ≥10 mm From Baseline in Schirmer Test Value Without Anesthesia for Study Eye | Week 2 (n=40, 41, 39, 40, 39) | 1 Participants |
| CP-690,550 Eye Drops 0.001% Group in Japan | Number of Participants Who Increase of ≥10 mm From Baseline in Schirmer Test Value Without Anesthesia for Study Eye | Week 1 (n=41, 41, 40, 40, 39) | 1 Participants |
| CP-690,550 Eye Drops 0.003% Group in Japan | Number of Participants Who Increase of ≥10 mm From Baseline in Schirmer Test Value Without Anesthesia for Study Eye | Week 1 (n=41, 41, 40, 40, 39) | 0 Participants |
| CP-690,550 Eye Drops 0.003% Group in Japan | Number of Participants Who Increase of ≥10 mm From Baseline in Schirmer Test Value Without Anesthesia for Study Eye | Week 2 (n=40, 41, 39, 40, 39) | 0 Participants |
| CP-690,550 Eye Drops 0.003% Group in Japan | Number of Participants Who Increase of ≥10 mm From Baseline in Schirmer Test Value Without Anesthesia for Study Eye | Week 4 (n=41, 40, 35, 40, 38) | 0 Participants |
| CP-690,550 Eye Drops 0.003% Group in Japan | Number of Participants Who Increase of ≥10 mm From Baseline in Schirmer Test Value Without Anesthesia for Study Eye | Week 8 (n=41, 41, 40, 40, 39, LOCF) | 0 Participants |
| CP-690,550 Eye Drops 0.005% Group in Japan | Number of Participants Who Increase of ≥10 mm From Baseline in Schirmer Test Value Without Anesthesia for Study Eye | Week 2 (n=40, 41, 39, 40, 39) | 2 Participants |
| CP-690,550 Eye Drops 0.005% Group in Japan | Number of Participants Who Increase of ≥10 mm From Baseline in Schirmer Test Value Without Anesthesia for Study Eye | Week 1 (n=41, 41, 40, 40, 39) | 1 Participants |
| CP-690,550 Eye Drops 0.005% Group in Japan | Number of Participants Who Increase of ≥10 mm From Baseline in Schirmer Test Value Without Anesthesia for Study Eye | Week 8 (n=41, 41, 40, 40, 39, LOCF) | 1 Participants |
| CP-690,550 Eye Drops 0.005% Group in Japan | Number of Participants Who Increase of ≥10 mm From Baseline in Schirmer Test Value Without Anesthesia for Study Eye | Week 4 (n=41, 40, 35, 40, 38) | 2 Participants |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Number of Participants Who Increase of ≥10 mm From Baseline in Schirmer Test Value Without Anesthesia for Study Eye | Week 2 (n=40, 41, 39, 40, 39) | 2 Participants |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Number of Participants Who Increase of ≥10 mm From Baseline in Schirmer Test Value Without Anesthesia for Study Eye | Week 4 (n=41, 40, 35, 40, 38) | 1 Participants |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Number of Participants Who Increase of ≥10 mm From Baseline in Schirmer Test Value Without Anesthesia for Study Eye | Week 8 (n=41, 41, 40, 40, 39, LOCF) | 3 Participants |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Number of Participants Who Increase of ≥10 mm From Baseline in Schirmer Test Value Without Anesthesia for Study Eye | Week 1 (n=41, 41, 40, 40, 39) | 1 Participants |
Secondary
Number of Participants With Nonocular Adverse Events (AEs) by Severity
Counts of participants who had treatment-emergent nonocular AEs, defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category.
Time frame: 8 weeks
Population: Safety analysis set: Participants who received at least 1 dose of study treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 Eye Drops Vehicle Group in Japan | Number of Participants With Nonocular Adverse Events (AEs) by Severity | Mild | 7 Participants |
| CP-690,550 Eye Drops Vehicle Group in Japan | Number of Participants With Nonocular Adverse Events (AEs) by Severity | Moderate | 1 Participants |
| CP-690,550 Eye Drops Vehicle Group in Japan | Number of Participants With Nonocular Adverse Events (AEs) by Severity | Severe | 0 Participants |
| CP-690,550 Eye Drops 0.001% Group in Japan | Number of Participants With Nonocular Adverse Events (AEs) by Severity | Mild | 12 Participants |
| CP-690,550 Eye Drops 0.001% Group in Japan | Number of Participants With Nonocular Adverse Events (AEs) by Severity | Severe | 0 Participants |
| CP-690,550 Eye Drops 0.001% Group in Japan | Number of Participants With Nonocular Adverse Events (AEs) by Severity | Moderate | 0 Participants |
| CP-690,550 Eye Drops 0.003% Group in Japan | Number of Participants With Nonocular Adverse Events (AEs) by Severity | Moderate | 2 Participants |
| CP-690,550 Eye Drops 0.003% Group in Japan | Number of Participants With Nonocular Adverse Events (AEs) by Severity | Severe | 2 Participants |
| CP-690,550 Eye Drops 0.003% Group in Japan | Number of Participants With Nonocular Adverse Events (AEs) by Severity | Mild | 10 Participants |
| CP-690,550 Eye Drops 0.005% Group in Japan | Number of Participants With Nonocular Adverse Events (AEs) by Severity | Moderate | 0 Participants |
| CP-690,550 Eye Drops 0.005% Group in Japan | Number of Participants With Nonocular Adverse Events (AEs) by Severity | Mild | 10 Participants |
| CP-690,550 Eye Drops 0.005% Group in Japan | Number of Participants With Nonocular Adverse Events (AEs) by Severity | Severe | 0 Participants |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Number of Participants With Nonocular Adverse Events (AEs) by Severity | Severe | 0 Participants |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Number of Participants With Nonocular Adverse Events (AEs) by Severity | Mild | 8 Participants |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Number of Participants With Nonocular Adverse Events (AEs) by Severity | Moderate | 0 Participants |
| CP-690,550 Eye Drops Vehicle Group in Korea | Number of Participants With Nonocular Adverse Events (AEs) by Severity | Severe | 0 Participants |
| CP-690,550 Eye Drops Vehicle Group in Korea | Number of Participants With Nonocular Adverse Events (AEs) by Severity | Mild | 2 Participants |
| CP-690,550 Eye Drops Vehicle Group in Korea | Number of Participants With Nonocular Adverse Events (AEs) by Severity | Moderate | 3 Participants |
| CP-690,550 Eye Drops 0.001% Group in Korea | Number of Participants With Nonocular Adverse Events (AEs) by Severity | Moderate | 1 Participants |
| CP-690,550 Eye Drops 0.001% Group in Korea | Number of Participants With Nonocular Adverse Events (AEs) by Severity | Mild | 1 Participants |
| CP-690,550 Eye Drops 0.001% Group in Korea | Number of Participants With Nonocular Adverse Events (AEs) by Severity | Severe | 0 Participants |
| CP-690,550 Eye Drops 0.003% Group in Korea | Number of Participants With Nonocular Adverse Events (AEs) by Severity | Moderate | 4 Participants |
| CP-690,550 Eye Drops 0.003% Group in Korea | Number of Participants With Nonocular Adverse Events (AEs) by Severity | Mild | 5 Participants |
| CP-690,550 Eye Drops 0.003% Group in Korea | Number of Participants With Nonocular Adverse Events (AEs) by Severity | Severe | 0 Participants |
| CP-690,550 Eye Drops 0.005% Group in Korea | Number of Participants With Nonocular Adverse Events (AEs) by Severity | Severe | 0 Participants |
| CP-690,550 Eye Drops 0.005% Group in Korea | Number of Participants With Nonocular Adverse Events (AEs) by Severity | Mild | 4 Participants |
| CP-690,550 Eye Drops 0.005% Group in Korea | Number of Participants With Nonocular Adverse Events (AEs) by Severity | Moderate | 2 Participants |
Secondary
Number of Participants With Ocular Adverse Events (AEs)by Severity
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Ocular AEs are the events which are localized in the ocular region. Participants with multiple occurrences of an AE within a category were counted once within the category.
Time frame: 8 weeks
Population: Safety analysis set: Participants who received at least 1 dose of study treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 Eye Drops Vehicle Group in Japan | Number of Participants With Ocular Adverse Events (AEs)by Severity | Severe | 0 Participants |
| CP-690,550 Eye Drops Vehicle Group in Japan | Number of Participants With Ocular Adverse Events (AEs)by Severity | Mild | 4 Participants |
| CP-690,550 Eye Drops Vehicle Group in Japan | Number of Participants With Ocular Adverse Events (AEs)by Severity | Moderate | 0 Participants |
| CP-690,550 Eye Drops 0.001% Group in Japan | Number of Participants With Ocular Adverse Events (AEs)by Severity | Severe | 1 Participants |
| CP-690,550 Eye Drops 0.001% Group in Japan | Number of Participants With Ocular Adverse Events (AEs)by Severity | Moderate | 0 Participants |
| CP-690,550 Eye Drops 0.001% Group in Japan | Number of Participants With Ocular Adverse Events (AEs)by Severity | Mild | 0 Participants |
| CP-690,550 Eye Drops 0.003% Group in Japan | Number of Participants With Ocular Adverse Events (AEs)by Severity | Mild | 4 Participants |
| CP-690,550 Eye Drops 0.003% Group in Japan | Number of Participants With Ocular Adverse Events (AEs)by Severity | Severe | 2 Participants |
| CP-690,550 Eye Drops 0.003% Group in Japan | Number of Participants With Ocular Adverse Events (AEs)by Severity | Moderate | 1 Participants |
| CP-690,550 Eye Drops 0.005% Group in Japan | Number of Participants With Ocular Adverse Events (AEs)by Severity | Severe | 0 Participants |
| CP-690,550 Eye Drops 0.005% Group in Japan | Number of Participants With Ocular Adverse Events (AEs)by Severity | Mild | 2 Participants |
| CP-690,550 Eye Drops 0.005% Group in Japan | Number of Participants With Ocular Adverse Events (AEs)by Severity | Moderate | 0 Participants |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Number of Participants With Ocular Adverse Events (AEs)by Severity | Moderate | 0 Participants |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Number of Participants With Ocular Adverse Events (AEs)by Severity | Mild | 2 Participants |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Number of Participants With Ocular Adverse Events (AEs)by Severity | Severe | 0 Participants |
| CP-690,550 Eye Drops Vehicle Group in Korea | Number of Participants With Ocular Adverse Events (AEs)by Severity | Moderate | 2 Participants |
| CP-690,550 Eye Drops Vehicle Group in Korea | Number of Participants With Ocular Adverse Events (AEs)by Severity | Mild | 3 Participants |
| CP-690,550 Eye Drops Vehicle Group in Korea | Number of Participants With Ocular Adverse Events (AEs)by Severity | Severe | 0 Participants |
| CP-690,550 Eye Drops 0.001% Group in Korea | Number of Participants With Ocular Adverse Events (AEs)by Severity | Severe | 0 Participants |
| CP-690,550 Eye Drops 0.001% Group in Korea | Number of Participants With Ocular Adverse Events (AEs)by Severity | Mild | 7 Participants |
| CP-690,550 Eye Drops 0.001% Group in Korea | Number of Participants With Ocular Adverse Events (AEs)by Severity | Moderate | 3 Participants |
| CP-690,550 Eye Drops 0.003% Group in Korea | Number of Participants With Ocular Adverse Events (AEs)by Severity | Moderate | 6 Participants |
| CP-690,550 Eye Drops 0.003% Group in Korea | Number of Participants With Ocular Adverse Events (AEs)by Severity | Severe | 2 Participants |
| CP-690,550 Eye Drops 0.003% Group in Korea | Number of Participants With Ocular Adverse Events (AEs)by Severity | Mild | 0 Participants |
| CP-690,550 Eye Drops 0.005% Group in Korea | Number of Participants With Ocular Adverse Events (AEs)by Severity | Moderate | 4 Participants |
| CP-690,550 Eye Drops 0.005% Group in Korea | Number of Participants With Ocular Adverse Events (AEs)by Severity | Severe | 0 Participants |
| CP-690,550 Eye Drops 0.005% Group in Korea | Number of Participants With Ocular Adverse Events (AEs)by Severity | Mild | 6 Participants |
Secondary
Percentage of Participants Demonstrating 100 Percent Clearing of Corneal Staining for Study Eye
Percentage of participants demonstrating corneal staining score = 0 which indicates no damage in corneal surface. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Time frame: Week 1, 2, 4 and 8
Population: Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data at Week 8.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 Eye Drops Vehicle Group in Japan | Percentage of Participants Demonstrating 100 Percent Clearing of Corneal Staining for Study Eye | Week 1 (n=41, 41, 40, 40, 39) | 4.9 Percentage of participants |
| CP-690,550 Eye Drops Vehicle Group in Japan | Percentage of Participants Demonstrating 100 Percent Clearing of Corneal Staining for Study Eye | Week 2 (n=40, 41, 39, 40, 39) | 2.5 Percentage of participants |
| CP-690,550 Eye Drops Vehicle Group in Japan | Percentage of Participants Demonstrating 100 Percent Clearing of Corneal Staining for Study Eye | Week 4 (n=41, 40, 35, 40, 38) | 12.2 Percentage of participants |
| CP-690,550 Eye Drops Vehicle Group in Japan | Percentage of Participants Demonstrating 100 Percent Clearing of Corneal Staining for Study Eye | Week 8 (n=41, 41, 40, 40, 39, LOCF) | 12.2 Percentage of participants |
| CP-690,550 Eye Drops 0.001% Group in Japan | Percentage of Participants Demonstrating 100 Percent Clearing of Corneal Staining for Study Eye | Week 1 (n=41, 41, 40, 40, 39) | 2.4 Percentage of participants |
| CP-690,550 Eye Drops 0.001% Group in Japan | Percentage of Participants Demonstrating 100 Percent Clearing of Corneal Staining for Study Eye | Week 8 (n=41, 41, 40, 40, 39, LOCF) | 4.9 Percentage of participants |
| CP-690,550 Eye Drops 0.001% Group in Japan | Percentage of Participants Demonstrating 100 Percent Clearing of Corneal Staining for Study Eye | Week 2 (n=40, 41, 39, 40, 39) | 2.4 Percentage of participants |
| CP-690,550 Eye Drops 0.001% Group in Japan | Percentage of Participants Demonstrating 100 Percent Clearing of Corneal Staining for Study Eye | Week 4 (n=41, 40, 35, 40, 38) | 5.0 Percentage of participants |
| CP-690,550 Eye Drops 0.003% Group in Japan | Percentage of Participants Demonstrating 100 Percent Clearing of Corneal Staining for Study Eye | Week 8 (n=41, 41, 40, 40, 39, LOCF) | 7.5 Percentage of participants |
| CP-690,550 Eye Drops 0.003% Group in Japan | Percentage of Participants Demonstrating 100 Percent Clearing of Corneal Staining for Study Eye | Week 2 (n=40, 41, 39, 40, 39) | 5.1 Percentage of participants |
| CP-690,550 Eye Drops 0.003% Group in Japan | Percentage of Participants Demonstrating 100 Percent Clearing of Corneal Staining for Study Eye | Week 4 (n=41, 40, 35, 40, 38) | 8.6 Percentage of participants |
| CP-690,550 Eye Drops 0.003% Group in Japan | Percentage of Participants Demonstrating 100 Percent Clearing of Corneal Staining for Study Eye | Week 1 (n=41, 41, 40, 40, 39) | 5.0 Percentage of participants |
| CP-690,550 Eye Drops 0.005% Group in Japan | Percentage of Participants Demonstrating 100 Percent Clearing of Corneal Staining for Study Eye | Week 1 (n=41, 41, 40, 40, 39) | 0 Percentage of participants |
| CP-690,550 Eye Drops 0.005% Group in Japan | Percentage of Participants Demonstrating 100 Percent Clearing of Corneal Staining for Study Eye | Week 2 (n=40, 41, 39, 40, 39) | 7.5 Percentage of participants |
| CP-690,550 Eye Drops 0.005% Group in Japan | Percentage of Participants Demonstrating 100 Percent Clearing of Corneal Staining for Study Eye | Week 8 (n=41, 41, 40, 40, 39, LOCF) | 7.5 Percentage of participants |
| CP-690,550 Eye Drops 0.005% Group in Japan | Percentage of Participants Demonstrating 100 Percent Clearing of Corneal Staining for Study Eye | Week 4 (n=41, 40, 35, 40, 38) | 7.5 Percentage of participants |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Percentage of Participants Demonstrating 100 Percent Clearing of Corneal Staining for Study Eye | Week 8 (n=41, 41, 40, 40, 39, LOCF) | 0 Percentage of participants |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Percentage of Participants Demonstrating 100 Percent Clearing of Corneal Staining for Study Eye | Week 4 (n=41, 40, 35, 40, 38) | 2.6 Percentage of participants |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Percentage of Participants Demonstrating 100 Percent Clearing of Corneal Staining for Study Eye | Week 2 (n=40, 41, 39, 40, 39) | 2.6 Percentage of participants |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Percentage of Participants Demonstrating 100 Percent Clearing of Corneal Staining for Study Eye | Week 1 (n=41, 41, 40, 40, 39) | 0 Percentage of participants |
Secondary
Percentage of Participants Demonstrating ≥10 Unit Decrease in Ocular Surface Disease Index (OSDI) Total Score From Baseline
The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 \[none of the time\] to 4 \[all of the time\]. The total OSDI score was then calculated on the basis of the following formula: OSDI=\[(sum of scores for all questions answered) × 100\]/\[(total number of questions answered) × 4\]. The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Time frame: Week 1, 2, 4 and 8
Population: Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 Eye Drops Vehicle Group in Japan | Percentage of Participants Demonstrating ≥10 Unit Decrease in Ocular Surface Disease Index (OSDI) Total Score From Baseline | Week 4 (n=41, 40, 35, 40, 38) | 34.1 Percentage of participants |
| CP-690,550 Eye Drops Vehicle Group in Japan | Percentage of Participants Demonstrating ≥10 Unit Decrease in Ocular Surface Disease Index (OSDI) Total Score From Baseline | Week 1 (n=41, 41, 40, 40, 39) | 14.6 Percentage of participants |
| CP-690,550 Eye Drops Vehicle Group in Japan | Percentage of Participants Demonstrating ≥10 Unit Decrease in Ocular Surface Disease Index (OSDI) Total Score From Baseline | Week 2 (n=40, 41, 40, 40, 39) | 32.5 Percentage of participants |
| CP-690,550 Eye Drops Vehicle Group in Japan | Percentage of Participants Demonstrating ≥10 Unit Decrease in Ocular Surface Disease Index (OSDI) Total Score From Baseline | Week 8 (n=41, 41, 40, 40, 39, LOCF) | 34.1 Percentage of participants |
| CP-690,550 Eye Drops 0.001% Group in Japan | Percentage of Participants Demonstrating ≥10 Unit Decrease in Ocular Surface Disease Index (OSDI) Total Score From Baseline | Week 2 (n=40, 41, 40, 40, 39) | 34.1 Percentage of participants |
| CP-690,550 Eye Drops 0.001% Group in Japan | Percentage of Participants Demonstrating ≥10 Unit Decrease in Ocular Surface Disease Index (OSDI) Total Score From Baseline | Week 1 (n=41, 41, 40, 40, 39) | 24.4 Percentage of participants |
| CP-690,550 Eye Drops 0.001% Group in Japan | Percentage of Participants Demonstrating ≥10 Unit Decrease in Ocular Surface Disease Index (OSDI) Total Score From Baseline | Week 8 (n=41, 41, 40, 40, 39, LOCF) | 41.5 Percentage of participants |
| CP-690,550 Eye Drops 0.001% Group in Japan | Percentage of Participants Demonstrating ≥10 Unit Decrease in Ocular Surface Disease Index (OSDI) Total Score From Baseline | Week 4 (n=41, 40, 35, 40, 38) | 37.5 Percentage of participants |
| CP-690,550 Eye Drops 0.003% Group in Japan | Percentage of Participants Demonstrating ≥10 Unit Decrease in Ocular Surface Disease Index (OSDI) Total Score From Baseline | Week 1 (n=41, 41, 40, 40, 39) | 12.5 Percentage of participants |
| CP-690,550 Eye Drops 0.003% Group in Japan | Percentage of Participants Demonstrating ≥10 Unit Decrease in Ocular Surface Disease Index (OSDI) Total Score From Baseline | Week 8 (n=41, 41, 40, 40, 39, LOCF) | 22.5 Percentage of participants |
| CP-690,550 Eye Drops 0.003% Group in Japan | Percentage of Participants Demonstrating ≥10 Unit Decrease in Ocular Surface Disease Index (OSDI) Total Score From Baseline | Week 2 (n=40, 41, 40, 40, 39) | 27.5 Percentage of participants |
| CP-690,550 Eye Drops 0.003% Group in Japan | Percentage of Participants Demonstrating ≥10 Unit Decrease in Ocular Surface Disease Index (OSDI) Total Score From Baseline | Week 4 (n=41, 40, 35, 40, 38) | 25.7 Percentage of participants |
| CP-690,550 Eye Drops 0.005% Group in Japan | Percentage of Participants Demonstrating ≥10 Unit Decrease in Ocular Surface Disease Index (OSDI) Total Score From Baseline | Week 1 (n=41, 41, 40, 40, 39) | 22.5 Percentage of participants |
| CP-690,550 Eye Drops 0.005% Group in Japan | Percentage of Participants Demonstrating ≥10 Unit Decrease in Ocular Surface Disease Index (OSDI) Total Score From Baseline | Week 8 (n=41, 41, 40, 40, 39, LOCF) | 35.0 Percentage of participants |
| CP-690,550 Eye Drops 0.005% Group in Japan | Percentage of Participants Demonstrating ≥10 Unit Decrease in Ocular Surface Disease Index (OSDI) Total Score From Baseline | Week 4 (n=41, 40, 35, 40, 38) | 35.0 Percentage of participants |
| CP-690,550 Eye Drops 0.005% Group in Japan | Percentage of Participants Demonstrating ≥10 Unit Decrease in Ocular Surface Disease Index (OSDI) Total Score From Baseline | Week 2 (n=40, 41, 40, 40, 39) | 25.0 Percentage of participants |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Percentage of Participants Demonstrating ≥10 Unit Decrease in Ocular Surface Disease Index (OSDI) Total Score From Baseline | Week 8 (n=41, 41, 40, 40, 39, LOCF) | 20.5 Percentage of participants |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Percentage of Participants Demonstrating ≥10 Unit Decrease in Ocular Surface Disease Index (OSDI) Total Score From Baseline | Week 1 (n=41, 41, 40, 40, 39) | 20.5 Percentage of participants |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Percentage of Participants Demonstrating ≥10 Unit Decrease in Ocular Surface Disease Index (OSDI) Total Score From Baseline | Week 2 (n=40, 41, 40, 40, 39) | 20.5 Percentage of participants |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Percentage of Participants Demonstrating ≥10 Unit Decrease in Ocular Surface Disease Index (OSDI) Total Score From Baseline | Week 4 (n=41, 40, 35, 40, 38) | 18.4 Percentage of participants |
Secondary
Percentage of Participants Who Achieve ≥10 mm Schirmer Test Value Without Anesthesia for Study Eye
The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Time frame: Week 1, 2, 4 and 8
Population: Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data at Week 8.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 Eye Drops Vehicle Group in Japan | Percentage of Participants Who Achieve ≥10 mm Schirmer Test Value Without Anesthesia for Study Eye | Week 1 (n=41, 41, 40, 40, 39) | 7.3 Percentage of participants |
| CP-690,550 Eye Drops Vehicle Group in Japan | Percentage of Participants Who Achieve ≥10 mm Schirmer Test Value Without Anesthesia for Study Eye | Week 2 (n=40, 41, 39, 40, 39) | 2.5 Percentage of participants |
| CP-690,550 Eye Drops Vehicle Group in Japan | Percentage of Participants Who Achieve ≥10 mm Schirmer Test Value Without Anesthesia for Study Eye | Week 4 (n=41, 40, 35, 40, 38) | 7.3 Percentage of participants |
| CP-690,550 Eye Drops Vehicle Group in Japan | Percentage of Participants Who Achieve ≥10 mm Schirmer Test Value Without Anesthesia for Study Eye | Week 8 (n=41, 41, 40, 40, 39, LOCF) | 9.8 Percentage of participants |
| CP-690,550 Eye Drops 0.001% Group in Japan | Percentage of Participants Who Achieve ≥10 mm Schirmer Test Value Without Anesthesia for Study Eye | Week 1 (n=41, 41, 40, 40, 39) | 4.9 Percentage of participants |
| CP-690,550 Eye Drops 0.001% Group in Japan | Percentage of Participants Who Achieve ≥10 mm Schirmer Test Value Without Anesthesia for Study Eye | Week 8 (n=41, 41, 40, 40, 39, LOCF) | 4.9 Percentage of participants |
| CP-690,550 Eye Drops 0.001% Group in Japan | Percentage of Participants Who Achieve ≥10 mm Schirmer Test Value Without Anesthesia for Study Eye | Week 2 (n=40, 41, 39, 40, 39) | 4.9 Percentage of participants |
| CP-690,550 Eye Drops 0.001% Group in Japan | Percentage of Participants Who Achieve ≥10 mm Schirmer Test Value Without Anesthesia for Study Eye | Week 4 (n=41, 40, 35, 40, 38) | 5.0 Percentage of participants |
| CP-690,550 Eye Drops 0.003% Group in Japan | Percentage of Participants Who Achieve ≥10 mm Schirmer Test Value Without Anesthesia for Study Eye | Week 8 (n=41, 41, 40, 40, 39, LOCF) | 2.5 Percentage of participants |
| CP-690,550 Eye Drops 0.003% Group in Japan | Percentage of Participants Who Achieve ≥10 mm Schirmer Test Value Without Anesthesia for Study Eye | Week 2 (n=40, 41, 39, 40, 39) | 2.6 Percentage of participants |
| CP-690,550 Eye Drops 0.003% Group in Japan | Percentage of Participants Who Achieve ≥10 mm Schirmer Test Value Without Anesthesia for Study Eye | Week 4 (n=41, 40, 35, 40, 38) | 2.9 Percentage of participants |
| CP-690,550 Eye Drops 0.003% Group in Japan | Percentage of Participants Who Achieve ≥10 mm Schirmer Test Value Without Anesthesia for Study Eye | Week 1 (n=41, 41, 40, 40, 39) | 0 Percentage of participants |
| CP-690,550 Eye Drops 0.005% Group in Japan | Percentage of Participants Who Achieve ≥10 mm Schirmer Test Value Without Anesthesia for Study Eye | Week 1 (n=41, 41, 40, 40, 39) | 2.5 Percentage of participants |
| CP-690,550 Eye Drops 0.005% Group in Japan | Percentage of Participants Who Achieve ≥10 mm Schirmer Test Value Without Anesthesia for Study Eye | Week 2 (n=40, 41, 39, 40, 39) | 7.5 Percentage of participants |
| CP-690,550 Eye Drops 0.005% Group in Japan | Percentage of Participants Who Achieve ≥10 mm Schirmer Test Value Without Anesthesia for Study Eye | Week 8 (n=41, 41, 40, 40, 39, LOCF) | 5.0 Percentage of participants |
| CP-690,550 Eye Drops 0.005% Group in Japan | Percentage of Participants Who Achieve ≥10 mm Schirmer Test Value Without Anesthesia for Study Eye | Week 4 (n=41, 40, 35, 40, 38) | 7.5 Percentage of participants |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Percentage of Participants Who Achieve ≥10 mm Schirmer Test Value Without Anesthesia for Study Eye | Week 8 (n=41, 41, 40, 40, 39, LOCF) | 12.8 Percentage of participants |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Percentage of Participants Who Achieve ≥10 mm Schirmer Test Value Without Anesthesia for Study Eye | Week 4 (n=41, 40, 35, 40, 38) | 5.3 Percentage of participants |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Percentage of Participants Who Achieve ≥10 mm Schirmer Test Value Without Anesthesia for Study Eye | Week 2 (n=40, 41, 39, 40, 39) | 10.3 Percentage of participants |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Percentage of Participants Who Achieve ≥10 mm Schirmer Test Value Without Anesthesia for Study Eye | Week 1 (n=41, 41, 40, 40, 39) | 7.7 Percentage of participants |
Secondary
Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale
Ocular tolerability was assessed for the 5 symptoms (burning sensation, blurred vision, ocular discomfort, pain, tearing), based on a 4-point severity scale (none, minor, moderate, and severe). Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Time frame: 8 weeks
Population: Safety analysis set: Participants who received at least 1 dose of study treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 Eye Drops Vehicle Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Severe for burning sensation | 0 Participants |
| CP-690,550 Eye Drops Vehicle Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | None for tearing | 40 Participants |
| CP-690,550 Eye Drops Vehicle Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Moderate for pain | 0 Participants |
| CP-690,550 Eye Drops Vehicle Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Minor for ocular discomfort | 10 Participants |
| CP-690,550 Eye Drops Vehicle Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Minor for burning sensation | 15 Participants |
| CP-690,550 Eye Drops Vehicle Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Minor for blurring of vision | 9 Participants |
| CP-690,550 Eye Drops Vehicle Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Severe for pain | 0 Participants |
| CP-690,550 Eye Drops Vehicle Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Moderate for burning sensation | 0 Participants |
| CP-690,550 Eye Drops Vehicle Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Moderate for tearing | 0 Participants |
| CP-690,550 Eye Drops Vehicle Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Moderate for blurring of vision | 0 Participants |
| CP-690,550 Eye Drops Vehicle Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Severe for ocular discomfort | 0 Participants |
| CP-690,550 Eye Drops Vehicle Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | None for ocular discomfort | 30 Participants |
| CP-690,550 Eye Drops Vehicle Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | None for blurring of vision | 32 Participants |
| CP-690,550 Eye Drops Vehicle Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Minor for pain | 13 Participants |
| CP-690,550 Eye Drops Vehicle Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | None for pain | 28 Participants |
| CP-690,550 Eye Drops Vehicle Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Severe for blurring of vision | 0 Participants |
| CP-690,550 Eye Drops Vehicle Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Severe for tearing | 0 Participants |
| CP-690,550 Eye Drops Vehicle Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Minor for tearing | 1 Participants |
| CP-690,550 Eye Drops Vehicle Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | None for burning sensation | 26 Participants |
| CP-690,550 Eye Drops Vehicle Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Moderate for ocular discomfort | 1 Participants |
| CP-690,550 Eye Drops 0.001% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Minor for pain | 11 Participants |
| CP-690,550 Eye Drops 0.001% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | None for blurring of vision | 33 Participants |
| CP-690,550 Eye Drops 0.001% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | None for pain | 30 Participants |
| CP-690,550 Eye Drops 0.001% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | None for burning sensation | 22 Participants |
| CP-690,550 Eye Drops 0.001% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Severe for pain | 1 Participants |
| CP-690,550 Eye Drops 0.001% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Severe for burning sensation | 1 Participants |
| CP-690,550 Eye Drops 0.001% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Minor for burning sensation | 19 Participants |
| CP-690,550 Eye Drops 0.001% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Moderate for ocular discomfort | 1 Participants |
| CP-690,550 Eye Drops 0.001% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Severe for tearing | 0 Participants |
| CP-690,550 Eye Drops 0.001% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Severe for ocular discomfort | 0 Participants |
| CP-690,550 Eye Drops 0.001% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Minor for tearing | 3 Participants |
| CP-690,550 Eye Drops 0.001% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Moderate for burning sensation | 0 Participants |
| CP-690,550 Eye Drops 0.001% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | None for ocular discomfort | 29 Participants |
| CP-690,550 Eye Drops 0.001% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Moderate for pain | 0 Participants |
| CP-690,550 Eye Drops 0.001% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | None for tearing | 38 Participants |
| CP-690,550 Eye Drops 0.001% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Minor for blurring of vision | 8 Participants |
| CP-690,550 Eye Drops 0.001% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Moderate for tearing | 1 Participants |
| CP-690,550 Eye Drops 0.001% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Severe for blurring of vision | 0 Participants |
| CP-690,550 Eye Drops 0.001% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Minor for ocular discomfort | 12 Participants |
| CP-690,550 Eye Drops 0.001% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Moderate for blurring of vision | 1 Participants |
| CP-690,550 Eye Drops 0.003% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Severe for ocular discomfort | 0 Participants |
| CP-690,550 Eye Drops 0.003% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Minor for ocular discomfort | 9 Participants |
| CP-690,550 Eye Drops 0.003% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Moderate for ocular discomfort | 2 Participants |
| CP-690,550 Eye Drops 0.003% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Minor for blurring of vision | 7 Participants |
| CP-690,550 Eye Drops 0.003% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | None for blurring of vision | 32 Participants |
| CP-690,550 Eye Drops 0.003% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Moderate for tearing | 0 Participants |
| CP-690,550 Eye Drops 0.003% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Moderate for blurring of vision | 2 Participants |
| CP-690,550 Eye Drops 0.003% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Minor for tearing | 2 Participants |
| CP-690,550 Eye Drops 0.003% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Severe for blurring of vision | 0 Participants |
| CP-690,550 Eye Drops 0.003% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | None for tearing | 39 Participants |
| CP-690,550 Eye Drops 0.003% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | None for burning sensation | 26 Participants |
| CP-690,550 Eye Drops 0.003% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Severe for pain | 0 Participants |
| CP-690,550 Eye Drops 0.003% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Minor for burning sensation | 14 Participants |
| CP-690,550 Eye Drops 0.003% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Severe for tearing | 0 Participants |
| CP-690,550 Eye Drops 0.003% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Moderate for pain | 1 Participants |
| CP-690,550 Eye Drops 0.003% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Moderate for burning sensation | 1 Participants |
| CP-690,550 Eye Drops 0.003% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Minor for pain | 6 Participants |
| CP-690,550 Eye Drops 0.003% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Severe for burning sensation | 0 Participants |
| CP-690,550 Eye Drops 0.003% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | None for pain | 34 Participants |
| CP-690,550 Eye Drops 0.003% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | None for ocular discomfort | 30 Participants |
| CP-690,550 Eye Drops 0.005% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Minor for pain | 7 Participants |
| CP-690,550 Eye Drops 0.005% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Minor for blurring of vision | 8 Participants |
| CP-690,550 Eye Drops 0.005% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Severe for tearing | 0 Participants |
| CP-690,550 Eye Drops 0.005% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | None for burning sensation | 27 Participants |
| CP-690,550 Eye Drops 0.005% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | None for tearing | 37 Participants |
| CP-690,550 Eye Drops 0.005% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Moderate for ocular discomfort | 1 Participants |
| CP-690,550 Eye Drops 0.005% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Severe for burning sensation | 0 Participants |
| CP-690,550 Eye Drops 0.005% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Severe for blurring of vision | 0 Participants |
| CP-690,550 Eye Drops 0.005% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Minor for tearing | 3 Participants |
| CP-690,550 Eye Drops 0.005% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | None for pain | 32 Participants |
| CP-690,550 Eye Drops 0.005% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Severe for ocular discomfort | 0 Participants |
| CP-690,550 Eye Drops 0.005% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | None for blurring of vision | 32 Participants |
| CP-690,550 Eye Drops 0.005% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Moderate for blurring of vision | 0 Participants |
| CP-690,550 Eye Drops 0.005% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Moderate for tearing | 0 Participants |
| CP-690,550 Eye Drops 0.005% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Minor for ocular discomfort | 8 Participants |
| CP-690,550 Eye Drops 0.005% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Moderate for pain | 1 Participants |
| CP-690,550 Eye Drops 0.005% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | None for ocular discomfort | 31 Participants |
| CP-690,550 Eye Drops 0.005% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Moderate for burning sensation | 1 Participants |
| CP-690,550 Eye Drops 0.005% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Minor for burning sensation | 12 Participants |
| CP-690,550 Eye Drops 0.005% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Severe for pain | 0 Participants |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Minor for tearing | 3 Participants |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | None for blurring of vision | 36 Participants |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Minor for blurring of vision | 3 Participants |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Moderate for blurring of vision | 0 Participants |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Severe for blurring of vision | 0 Participants |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | None for burning sensation | 34 Participants |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Minor for burning sensation | 4 Participants |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Moderate for burning sensation | 0 Participants |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Severe for burning sensation | 1 Participants |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | None for ocular discomfort | 29 Participants |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Minor for ocular discomfort | 8 Participants |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Moderate for ocular discomfort | 1 Participants |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Severe for ocular discomfort | 1 Participants |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | None for pain | 34 Participants |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Minor for pain | 3 Participants |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Moderate for pain | 2 Participants |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Severe for pain | 0 Participants |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | None for tearing | 36 Participants |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Moderate for tearing | 0 Participants |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Severe for tearing | 0 Participants |
| CP-690,550 Eye Drops Vehicle Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Moderate for tearing | 0 Participants |
| CP-690,550 Eye Drops Vehicle Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | None for blurring of vision | 11 Participants |
| CP-690,550 Eye Drops Vehicle Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Minor for pain | 4 Participants |
| CP-690,550 Eye Drops Vehicle Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Minor for blurring of vision | 9 Participants |
| CP-690,550 Eye Drops Vehicle Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Severe for tearing | 0 Participants |
| CP-690,550 Eye Drops Vehicle Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Minor for burning sensation | 10 Participants |
| CP-690,550 Eye Drops Vehicle Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Moderate for burning sensation | 3 Participants |
| CP-690,550 Eye Drops Vehicle Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Moderate for pain | 4 Participants |
| CP-690,550 Eye Drops Vehicle Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | None for ocular discomfort | 6 Participants |
| CP-690,550 Eye Drops Vehicle Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Minor for tearing | 6 Participants |
| CP-690,550 Eye Drops Vehicle Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Moderate for blurring of vision | 1 Participants |
| CP-690,550 Eye Drops Vehicle Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Moderate for ocular discomfort | 6 Participants |
| CP-690,550 Eye Drops Vehicle Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Severe for ocular discomfort | 1 Participants |
| CP-690,550 Eye Drops Vehicle Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | None for pain | 12 Participants |
| CP-690,550 Eye Drops Vehicle Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Minor for ocular discomfort | 8 Participants |
| CP-690,550 Eye Drops Vehicle Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Severe for blurring of vision | 0 Participants |
| CP-690,550 Eye Drops Vehicle Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | None for tearing | 15 Participants |
| CP-690,550 Eye Drops Vehicle Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Severe for burning sensation | 1 Participants |
| CP-690,550 Eye Drops Vehicle Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | None for burning sensation | 7 Participants |
| CP-690,550 Eye Drops Vehicle Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Severe for pain | 1 Participants |
| CP-690,550 Eye Drops 0.001% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Minor for tearing | 4 Participants |
| CP-690,550 Eye Drops 0.001% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | None for ocular discomfort | 4 Participants |
| CP-690,550 Eye Drops 0.001% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Severe for ocular discomfort | 1 Participants |
| CP-690,550 Eye Drops 0.001% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Severe for burning sensation | 0 Participants |
| CP-690,550 Eye Drops 0.001% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | None for blurring of vision | 11 Participants |
| CP-690,550 Eye Drops 0.001% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | None for pain | 9 Participants |
| CP-690,550 Eye Drops 0.001% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Moderate for burning sensation | 2 Participants |
| CP-690,550 Eye Drops 0.001% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Minor for pain | 10 Participants |
| CP-690,550 Eye Drops 0.001% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Minor for burning sensation | 10 Participants |
| CP-690,550 Eye Drops 0.001% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Moderate for pain | 0 Participants |
| CP-690,550 Eye Drops 0.001% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | None for burning sensation | 7 Participants |
| CP-690,550 Eye Drops 0.001% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Severe for pain | 0 Participants |
| CP-690,550 Eye Drops 0.001% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Severe for blurring of vision | 0 Participants |
| CP-690,550 Eye Drops 0.001% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Severe for tearing | 0 Participants |
| CP-690,550 Eye Drops 0.001% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | None for tearing | 15 Participants |
| CP-690,550 Eye Drops 0.001% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Moderate for blurring of vision | 2 Participants |
| CP-690,550 Eye Drops 0.001% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Minor for blurring of vision | 6 Participants |
| CP-690,550 Eye Drops 0.001% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Moderate for tearing | 0 Participants |
| CP-690,550 Eye Drops 0.001% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Minor for ocular discomfort | 11 Participants |
| CP-690,550 Eye Drops 0.001% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Moderate for ocular discomfort | 3 Participants |
| CP-690,550 Eye Drops 0.003% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Minor for pain | 7 Participants |
| CP-690,550 Eye Drops 0.003% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Severe for pain | 0 Participants |
| CP-690,550 Eye Drops 0.003% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Severe for blurring of vision | 0 Participants |
| CP-690,550 Eye Drops 0.003% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Minor for ocular discomfort | 6 Participants |
| CP-690,550 Eye Drops 0.003% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | None for tearing | 18 Participants |
| CP-690,550 Eye Drops 0.003% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | None for pain | 12 Participants |
| CP-690,550 Eye Drops 0.003% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Moderate for blurring of vision | 1 Participants |
| CP-690,550 Eye Drops 0.003% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | None for blurring of vision | 15 Participants |
| CP-690,550 Eye Drops 0.003% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Severe for burning sensation | 0 Participants |
| CP-690,550 Eye Drops 0.003% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Minor for tearing | 3 Participants |
| CP-690,550 Eye Drops 0.003% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Minor for blurring of vision | 5 Participants |
| CP-690,550 Eye Drops 0.003% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | None for ocular discomfort | 7 Participants |
| CP-690,550 Eye Drops 0.003% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Severe for tearing | 0 Participants |
| CP-690,550 Eye Drops 0.003% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Severe for ocular discomfort | 1 Participants |
| CP-690,550 Eye Drops 0.003% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Minor for burning sensation | 9 Participants |
| CP-690,550 Eye Drops 0.003% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Moderate for ocular discomfort | 7 Participants |
| CP-690,550 Eye Drops 0.003% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Moderate for tearing | 0 Participants |
| CP-690,550 Eye Drops 0.003% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Moderate for pain | 2 Participants |
| CP-690,550 Eye Drops 0.003% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | None for burning sensation | 11 Participants |
| CP-690,550 Eye Drops 0.003% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Moderate for burning sensation | 1 Participants |
| CP-690,550 Eye Drops 0.005% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Minor for pain | 9 Participants |
| CP-690,550 Eye Drops 0.005% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Minor for ocular discomfort | 8 Participants |
| CP-690,550 Eye Drops 0.005% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Minor for tearing | 2 Participants |
| CP-690,550 Eye Drops 0.005% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Severe for pain | 0 Participants |
| CP-690,550 Eye Drops 0.005% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Moderate for burning sensation | 2 Participants |
| CP-690,550 Eye Drops 0.005% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Severe for blurring of vision | 0 Participants |
| CP-690,550 Eye Drops 0.005% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Minor for blurring of vision | 7 Participants |
| CP-690,550 Eye Drops 0.005% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Severe for tearing | 0 Participants |
| CP-690,550 Eye Drops 0.005% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Moderate for ocular discomfort | 6 Participants |
| CP-690,550 Eye Drops 0.005% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | None for pain | 9 Participants |
| CP-690,550 Eye Drops 0.005% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | None for blurring of vision | 13 Participants |
| CP-690,550 Eye Drops 0.005% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Minor for burning sensation | 10 Participants |
| CP-690,550 Eye Drops 0.005% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | None for tearing | 19 Participants |
| CP-690,550 Eye Drops 0.005% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Severe for ocular discomfort | 1 Participants |
| CP-690,550 Eye Drops 0.005% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Moderate for blurring of vision | 1 Participants |
| CP-690,550 Eye Drops 0.005% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | None for burning sensation | 9 Participants |
| CP-690,550 Eye Drops 0.005% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Moderate for tearing | 0 Participants |
| CP-690,550 Eye Drops 0.005% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Moderate for pain | 3 Participants |
| CP-690,550 Eye Drops 0.005% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | Severe for burning sensation | 0 Participants |
| CP-690,550 Eye Drops 0.005% Group in Korea | Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale | None for ocular discomfort | 6 Participants |
Other Pre-specified
Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Human Leukocyte Antigen-DR Antibody Bound Per Cell for Study Eye
The average level of HLA-DR expression per cell was reported as HLA-DR antibody bound per cell (ABC). Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change = value at observation minus value at baseline.
Time frame: Baseline, Week 4 and 8
Population: A subset of intent-to-treat population collected impression cytology samples from both eyes at screening, week 4 and week 8.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Human Leukocyte Antigen-DR Antibody Bound Per Cell for Study Eye | Week 4 (n=7, 4, 9, 12, 8) | 1570.4 Antibodies bound per cell | Standard Deviation 8698.5 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Human Leukocyte Antigen-DR Antibody Bound Per Cell for Study Eye | Week 8 (n=6, 4, 6, 11, 10) | -1496.5 Antibodies bound per cell | Standard Deviation 10426.5 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Human Leukocyte Antigen-DR Antibody Bound Per Cell for Study Eye | Week 4 (n=7, 4, 9, 12, 8) | -13899.5 Antibodies bound per cell | Standard Deviation 13383.8 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Human Leukocyte Antigen-DR Antibody Bound Per Cell for Study Eye | Week 8 (n=6, 4, 6, 11, 10) | -8326.3 Antibodies bound per cell | Standard Deviation 11164.6 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Human Leukocyte Antigen-DR Antibody Bound Per Cell for Study Eye | Week 4 (n=7, 4, 9, 12, 8) | 5394.3 Antibodies bound per cell | Standard Deviation 10641.9 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Human Leukocyte Antigen-DR Antibody Bound Per Cell for Study Eye | Week 8 (n=6, 4, 6, 11, 10) | 56.0 Antibodies bound per cell | Standard Deviation 5308.4 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Human Leukocyte Antigen-DR Antibody Bound Per Cell for Study Eye | Week 8 (n=6, 4, 6, 11, 10) | 3431.9 Antibodies bound per cell | Standard Deviation 16532.5 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Human Leukocyte Antigen-DR Antibody Bound Per Cell for Study Eye | Week 4 (n=7, 4, 9, 12, 8) | 1573.8 Antibodies bound per cell | Standard Deviation 10087.5 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Human Leukocyte Antigen-DR Antibody Bound Per Cell for Study Eye | Week 4 (n=7, 4, 9, 12, 8) | -1908.6 Antibodies bound per cell | Standard Deviation 11259.4 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Human Leukocyte Antigen-DR Antibody Bound Per Cell for Study Eye | Week 8 (n=6, 4, 6, 11, 10) | 1148.5 Antibodies bound per cell | Standard Deviation 12129.6 |
Other Pre-specified
Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Percentage of Human Leukocyte Antigen (HLA)-DR Positive for Study Eye
Percentage of conjunctival epithelial cells that were positive with HLA-DR expression was calculated as HLA-DR Positive. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Time frame: Baseline, Week 4 and 8
Population: A subset of intent-to-treat population collected impression cytology samples from both eyes at screening, week 4 and week 8.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Percentage of Human Leukocyte Antigen (HLA)-DR Positive for Study Eye | Week 4 (n=7, 4, 9, 12, 8) | -10.27 Percentage of positive cells | Standard Deviation 20.73 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Percentage of Human Leukocyte Antigen (HLA)-DR Positive for Study Eye | Week 8 (n=6, 4, 6, 11, 10) | -6.77 Percentage of positive cells | Standard Deviation 18.19 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Percentage of Human Leukocyte Antigen (HLA)-DR Positive for Study Eye | Week 4 (n=7, 4, 9, 12, 8) | -0.87 Percentage of positive cells | Standard Deviation 18.24 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Percentage of Human Leukocyte Antigen (HLA)-DR Positive for Study Eye | Week 8 (n=6, 4, 6, 11, 10) | 6.65 Percentage of positive cells | Standard Deviation 25.65 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Percentage of Human Leukocyte Antigen (HLA)-DR Positive for Study Eye | Week 4 (n=7, 4, 9, 12, 8) | 11.51 Percentage of positive cells | Standard Deviation 18.74 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Percentage of Human Leukocyte Antigen (HLA)-DR Positive for Study Eye | Week 8 (n=6, 4, 6, 11, 10) | 5.17 Percentage of positive cells | Standard Deviation 24.73 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Percentage of Human Leukocyte Antigen (HLA)-DR Positive for Study Eye | Week 8 (n=6, 4, 6, 11, 10) | -1.05 Percentage of positive cells | Standard Deviation 35.75 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Percentage of Human Leukocyte Antigen (HLA)-DR Positive for Study Eye | Week 4 (n=7, 4, 9, 12, 8) | -6.83 Percentage of positive cells | Standard Deviation 28.64 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Percentage of Human Leukocyte Antigen (HLA)-DR Positive for Study Eye | Week 4 (n=7, 4, 9, 12, 8) | 18.30 Percentage of positive cells | Standard Deviation 30.4 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Percentage of Human Leukocyte Antigen (HLA)-DR Positive for Study Eye | Week 8 (n=6, 4, 6, 11, 10) | 11.74 Percentage of positive cells | Standard Deviation 24.84 |
Other Pre-specified
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Albumin
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time frame: Baseline, Week 4 and 8
Population: A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Albumin | Week 4 (n=4, 5, 2, 4, 3) | -228.00 mcg/mL | Standard Deviation 409.55 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Albumin | Week 8 (n=4, 6, 2, 5, 3) | 99.50 mcg/mL | Standard Deviation 354.15 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Albumin | Week 4 (n=4, 5, 2, 4, 3) | -28.20 mcg/mL | Standard Deviation 94.15 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Albumin | Week 8 (n=4, 6, 2, 5, 3) | 125.17 mcg/mL | Standard Deviation 292.09 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Albumin | Week 4 (n=4, 5, 2, 4, 3) | 42.50 mcg/mL | Standard Deviation 181.73 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Albumin | Week 8 (n=4, 6, 2, 5, 3) | 1.00 mcg/mL | Standard Deviation 147.08 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Albumin | Week 8 (n=4, 6, 2, 5, 3) | 96.00 mcg/mL | Standard Deviation 141.26 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Albumin | Week 4 (n=4, 5, 2, 4, 3) | 111.75 mcg/mL | Standard Deviation 293.07 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Albumin | Week 4 (n=4, 5, 2, 4, 3) | 164.67 mcg/mL | Standard Deviation 73.04 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Albumin | Week 8 (n=4, 6, 2, 5, 3) | 81.33 mcg/mL | Standard Deviation 75.63 |
Other Pre-specified
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Alpha-1 Antitrypsin
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time frame: Baseline, Week 4 and 8
Population: A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Alpha-1 Antitrypsin | Week 4 (n=4, 5, 2, 4, 3) | -1115.0 ng/mL | Standard Deviation 3226.2 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Alpha-1 Antitrypsin | Week 8 (n=4, 6, 2, 5, 3) | -2902.5 ng/mL | Standard Deviation 4534.4 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Alpha-1 Antitrypsin | Week 4 (n=4, 5, 2, 4, 3) | -4054.0 ng/mL | Standard Deviation 8558.2 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Alpha-1 Antitrypsin | Week 8 (n=4, 6, 2, 5, 3) | 505.0 ng/mL | Standard Deviation 2977.2 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Alpha-1 Antitrypsin | Week 4 (n=4, 5, 2, 4, 3) | 1535.0 ng/mL | Standard Deviation 2170.8 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Alpha-1 Antitrypsin | Week 8 (n=4, 6, 2, 5, 3) | -1375.0 ng/mL | Standard Deviation 1944.5 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Alpha-1 Antitrypsin | Week 8 (n=4, 6, 2, 5, 3) | 1220.8 ng/mL | Standard Deviation 4111.8 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Alpha-1 Antitrypsin | Week 4 (n=4, 5, 2, 4, 3) | -628.5 ng/mL | Standard Deviation 5314.7 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Alpha-1 Antitrypsin | Week 4 (n=4, 5, 2, 4, 3) | 5400.0 ng/mL | Standard Deviation 3104.5 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Alpha-1 Antitrypsin | Week 8 (n=4, 6, 2, 5, 3) | 2246.7 ng/mL | Standard Deviation 2329.9 |
Other Pre-specified
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Apolipoprotein C-3
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time frame: Baseline, Week 4 and 8
Population: A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Apolipoprotein C-3 | Week 4 (n=4, 5, 2, 4, 3) | -30.675 ng/mL | Standard Deviation 78.363 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Apolipoprotein C-3 | Week 8 (n=4, 6, 2, 5, 3) | -39.250 ng/mL | Standard Deviation 786.061 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Apolipoprotein C-3 | Week 4 (n=4, 5, 2, 4, 3) | -38.540 ng/mL | Standard Deviation 93.153 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Apolipoprotein C-3 | Week 8 (n=4, 6, 2, 5, 3) | -5.167 ng/mL | Standard Deviation 33.983 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Apolipoprotein C-3 | Week 4 (n=4, 5, 2, 4, 3) | -153.500 ng/mL | Standard Deviation 164.756 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Apolipoprotein C-3 | Week 8 (n=4, 6, 2, 5, 3) | -70.800 ng/mL | Standard Deviation 16.688 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Apolipoprotein C-3 | Week 8 (n=4, 6, 2, 5, 3) | -5102.010 ng/mL | Standard Deviation 11352.752 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Apolipoprotein C-3 | Week 4 (n=4, 5, 2, 4, 3) | -6384.063 ng/mL | Standard Deviation 12606.637 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Apolipoprotein C-3 | Week 4 (n=4, 5, 2, 4, 3) | 58.500 ng/mL | Standard Deviation 59.729 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Apolipoprotein C-3 | Week 8 (n=4, 6, 2, 5, 3) | -1.300 ng/mL | Standard Deviation 1.752 |
Other Pre-specified
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine ( C-C Motif) Ligand 20 (CCL20) (Alias Macrophage Inflammatory Protein 3 Alpha: MIP3A)
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time frame: Baseline, Week 4 and 8
Population: A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine ( C-C Motif) Ligand 20 (CCL20) (Alias Macrophage Inflammatory Protein 3 Alpha: MIP3A) | Week 4 (n=4, 5, 2, 4, 3) | 1.3 pg/mL | Standard Deviation 541.7 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine ( C-C Motif) Ligand 20 (CCL20) (Alias Macrophage Inflammatory Protein 3 Alpha: MIP3A) | Week 8 (n=4, 6, 2, 5, 3) | -1237.8 pg/mL | Standard Deviation 1975.3 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine ( C-C Motif) Ligand 20 (CCL20) (Alias Macrophage Inflammatory Protein 3 Alpha: MIP3A) | Week 4 (n=4, 5, 2, 4, 3) | 47.4 pg/mL | Standard Deviation 281.2 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine ( C-C Motif) Ligand 20 (CCL20) (Alias Macrophage Inflammatory Protein 3 Alpha: MIP3A) | Week 8 (n=4, 6, 2, 5, 3) | 534.5 pg/mL | Standard Deviation 868.9 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine ( C-C Motif) Ligand 20 (CCL20) (Alias Macrophage Inflammatory Protein 3 Alpha: MIP3A) | Week 4 (n=4, 5, 2, 4, 3) | 630.0 pg/mL | Standard Deviation 325.3 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine ( C-C Motif) Ligand 20 (CCL20) (Alias Macrophage Inflammatory Protein 3 Alpha: MIP3A) | Week 8 (n=4, 6, 2, 5, 3) | -360.0 pg/mL | Standard Deviation 1004.1 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine ( C-C Motif) Ligand 20 (CCL20) (Alias Macrophage Inflammatory Protein 3 Alpha: MIP3A) | Week 8 (n=4, 6, 2, 5, 3) | -327.6 pg/mL | Standard Deviation 2083.1 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine ( C-C Motif) Ligand 20 (CCL20) (Alias Macrophage Inflammatory Protein 3 Alpha: MIP3A) | Week 4 (n=4, 5, 2, 4, 3) | -1562.5 pg/mL | Standard Deviation 2787.4 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine ( C-C Motif) Ligand 20 (CCL20) (Alias Macrophage Inflammatory Protein 3 Alpha: MIP3A) | Week 4 (n=4, 5, 2, 4, 3) | -301.3 pg/mL | Standard Deviation 1138.3 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine ( C-C Motif) Ligand 20 (CCL20) (Alias Macrophage Inflammatory Protein 3 Alpha: MIP3A) | Week 8 (n=4, 6, 2, 5, 3) | 246.7 pg/mL | Standard Deviation 331.6 |
Other Pre-specified
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-C Motif) Ligand 5 (CCL5) (Alias Regulated on Activation, Normal T Cell Expressed, and Secreted: RANTES)
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time frame: Baseline, Week 4 and 8
Population: A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-C Motif) Ligand 5 (CCL5) (Alias Regulated on Activation, Normal T Cell Expressed, and Secreted: RANTES) | Week 4 (n=4, 5, 2, 4, 3) | 13.25 pg/mL | Standard Deviation 31.28 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-C Motif) Ligand 5 (CCL5) (Alias Regulated on Activation, Normal T Cell Expressed, and Secreted: RANTES) | Week 8 (n=4, 6, 2, 5, 3) | -61.48 pg/mL | Standard Deviation 79.46 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-C Motif) Ligand 5 (CCL5) (Alias Regulated on Activation, Normal T Cell Expressed, and Secreted: RANTES) | Week 4 (n=4, 5, 2, 4, 3) | -12.06 pg/mL | Standard Deviation 70.14 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-C Motif) Ligand 5 (CCL5) (Alias Regulated on Activation, Normal T Cell Expressed, and Secreted: RANTES) | Week 8 (n=4, 6, 2, 5, 3) | -3.83 pg/mL | Standard Deviation 81.17 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-C Motif) Ligand 5 (CCL5) (Alias Regulated on Activation, Normal T Cell Expressed, and Secreted: RANTES) | Week 4 (n=4, 5, 2, 4, 3) | 21.50 pg/mL | Standard Deviation 40.31 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-C Motif) Ligand 5 (CCL5) (Alias Regulated on Activation, Normal T Cell Expressed, and Secreted: RANTES) | Week 8 (n=4, 6, 2, 5, 3) | 6.50 pg/mL | Standard Deviation 36.06 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-C Motif) Ligand 5 (CCL5) (Alias Regulated on Activation, Normal T Cell Expressed, and Secreted: RANTES) | Week 8 (n=4, 6, 2, 5, 3) | -9.58 pg/mL | Standard Deviation 49.45 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-C Motif) Ligand 5 (CCL5) (Alias Regulated on Activation, Normal T Cell Expressed, and Secreted: RANTES) | Week 4 (n=4, 5, 2, 4, 3) | -28.98 pg/mL | Standard Deviation 57.5 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-C Motif) Ligand 5 (CCL5) (Alias Regulated on Activation, Normal T Cell Expressed, and Secreted: RANTES) | Week 4 (n=4, 5, 2, 4, 3) | 19.43 pg/mL | Standard Deviation 51.6 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-C Motif) Ligand 5 (CCL5) (Alias Regulated on Activation, Normal T Cell Expressed, and Secreted: RANTES) | Week 8 (n=4, 6, 2, 5, 3) | -8.93 pg/mL | Standard Deviation 15.77 |
Other Pre-specified
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-X-C Motif) Ligand 10 (CXCL10) (Alias Gamma-Interferon Inducible Protein 10: IP10)
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time frame: Baseline, Week 4 and 8
Population: A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-X-C Motif) Ligand 10 (CXCL10) (Alias Gamma-Interferon Inducible Protein 10: IP10) | Week 4 (n=3, 5, 2, 4, 3) | -1196.7 pg/mL | Standard Deviation 3885.1 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-X-C Motif) Ligand 10 (CXCL10) (Alias Gamma-Interferon Inducible Protein 10: IP10) | Week 8 (n=4, 6, 2, 5, 2) | -13440.0 pg/mL | Standard Deviation 27749.2 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-X-C Motif) Ligand 10 (CXCL10) (Alias Gamma-Interferon Inducible Protein 10: IP10) | Week 4 (n=3, 5, 2, 4, 3) | -7224.0 pg/mL | Standard Deviation 27315.6 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-X-C Motif) Ligand 10 (CXCL10) (Alias Gamma-Interferon Inducible Protein 10: IP10) | Week 8 (n=4, 6, 2, 5, 2) | 18971.7 pg/mL | Standard Deviation 30883.3 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-X-C Motif) Ligand 10 (CXCL10) (Alias Gamma-Interferon Inducible Protein 10: IP10) | Week 8 (n=4, 6, 2, 5, 2) | -6230.0 pg/mL | Standard Deviation 7028.6 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-X-C Motif) Ligand 10 (CXCL10) (Alias Gamma-Interferon Inducible Protein 10: IP10) | Week 4 (n=3, 5, 2, 4, 3) | 14545.0 pg/mL | Standard Deviation 24967.9 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-X-C Motif) Ligand 10 (CXCL10) (Alias Gamma-Interferon Inducible Protein 10: IP10) | Week 8 (n=4, 6, 2, 5, 2) | 6306.0 pg/mL | Standard Deviation 24845.5 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-X-C Motif) Ligand 10 (CXCL10) (Alias Gamma-Interferon Inducible Protein 10: IP10) | Week 4 (n=3, 5, 2, 4, 3) | -11622.5 pg/mL | Standard Deviation 28687.6 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-X-C Motif) Ligand 10 (CXCL10) (Alias Gamma-Interferon Inducible Protein 10: IP10) | Week 4 (n=3, 5, 2, 4, 3) | 15103.3 pg/mL | Standard Deviation 56584.3 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-X-C Motif) Ligand 10 (CXCL10) (Alias Gamma-Interferon Inducible Protein 10: IP10) | Week 8 (n=4, 6, 2, 5, 2) | -9690.0 pg/mL | Standard Deviation 13732 |
Other Pre-specified
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-X-C Motif) Ligand 9 (CXCL9) (Alias Monokine Induced by Gamma Interferon: MIG)
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time frame: Baseline, Week 4 and 8
Population: A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-X-C Motif) Ligand 9 (CXCL9) (Alias Monokine Induced by Gamma Interferon: MIG) | Week 4 (n=3, 4, 2, 4, 3) | -633.3 pg/mL | Standard Deviation 1325.5 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-X-C Motif) Ligand 9 (CXCL9) (Alias Monokine Induced by Gamma Interferon: MIG) | Week 8 (n=4, 5, 2, 5, 2) | -34722.5 pg/mL | Standard Deviation 62344.4 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-X-C Motif) Ligand 9 (CXCL9) (Alias Monokine Induced by Gamma Interferon: MIG) | Week 4 (n=3, 4, 2, 4, 3) | -47485.0 pg/mL | Standard Deviation 110811.6 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-X-C Motif) Ligand 9 (CXCL9) (Alias Monokine Induced by Gamma Interferon: MIG) | Week 8 (n=4, 5, 2, 5, 2) | 3118.0 pg/mL | Standard Deviation 23681.2 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-X-C Motif) Ligand 9 (CXCL9) (Alias Monokine Induced by Gamma Interferon: MIG) | Week 4 (n=3, 4, 2, 4, 3) | 21025.0 pg/mL | Standard Deviation 45078.1 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-X-C Motif) Ligand 9 (CXCL9) (Alias Monokine Induced by Gamma Interferon: MIG) | Week 8 (n=4, 5, 2, 5, 2) | -10150.0 pg/mL | Standard Deviation 2899.1 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-X-C Motif) Ligand 9 (CXCL9) (Alias Monokine Induced by Gamma Interferon: MIG) | Week 8 (n=4, 5, 2, 5, 2) | 22148.0 pg/mL | Standard Deviation 36704.1 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-X-C Motif) Ligand 9 (CXCL9) (Alias Monokine Induced by Gamma Interferon: MIG) | Week 4 (n=3, 4, 2, 4, 3) | -18020.0 pg/mL | Standard Deviation 44942.7 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-X-C Motif) Ligand 9 (CXCL9) (Alias Monokine Induced by Gamma Interferon: MIG) | Week 4 (n=3, 4, 2, 4, 3) | 14003.3 pg/mL | Standard Deviation 22925.3 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-X-C Motif) Ligand 9 (CXCL9) (Alias Monokine Induced by Gamma Interferon: MIG) | Week 8 (n=4, 5, 2, 5, 2) | -4220.0 pg/mL | Standard Deviation 5741.7 |
Other Pre-specified
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Epidermal Growth Factor
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time frame: Baseline, Week 4 and 8
Population: A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Epidermal Growth Factor | Week 4 (n=4, 5, 2, 4, 3) | -0.5 pg/mL | Standard Deviation 495.3 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Epidermal Growth Factor | Week 8 (n=4, 6, 2, 5, 3) | -15.5 pg/mL | Standard Deviation 370.2 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Epidermal Growth Factor | Week 4 (n=4, 5, 2, 4, 3) | -213.2 pg/mL | Standard Deviation 1803.5 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Epidermal Growth Factor | Week 8 (n=4, 6, 2, 5, 3) | 361.0 pg/mL | Standard Deviation 857.7 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Epidermal Growth Factor | Week 8 (n=4, 6, 2, 5, 3) | -885.0 pg/mL | Standard Deviation 1322.3 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Epidermal Growth Factor | Week 4 (n=4, 5, 2, 4, 3) | -138.5 pg/mL | Standard Deviation 186 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Epidermal Growth Factor | Week 8 (n=4, 6, 2, 5, 3) | -122.0 pg/mL | Standard Deviation 1612.5 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Epidermal Growth Factor | Week 4 (n=4, 5, 2, 4, 3) | 0.5 pg/mL | Standard Deviation 3816.2 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Epidermal Growth Factor | Week 8 (n=4, 6, 2, 5, 3) | -212.7 pg/mL | Standard Deviation 532.5 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Epidermal Growth Factor | Week 4 (n=4, 5, 2, 4, 3) | -121.7 pg/mL | Standard Deviation 1815.2 |
Other Pre-specified
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-12 P40/P35 Heterodimer (IL-12P70)
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time frame: Baseline, Week 4 and 8
Population: A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-12 P40/P35 Heterodimer (IL-12P70) | Week 4 (n=4, 5, 2, 4, 3) | -5.0 pg/mL | Standard Deviation 16.1 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-12 P40/P35 Heterodimer (IL-12P70) | Week 8 (n=4, 6, 2, 5, 3) | 17.5 pg/mL | Standard Deviation 21.7 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-12 P40/P35 Heterodimer (IL-12P70) | Week 4 (n=4, 5, 2, 4, 3) | -5.4 pg/mL | Standard Deviation 17 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-12 P40/P35 Heterodimer (IL-12P70) | Week 8 (n=4, 6, 2, 5, 3) | 15.8 pg/mL | Standard Deviation 57.9 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-12 P40/P35 Heterodimer (IL-12P70) | Week 4 (n=4, 5, 2, 4, 3) | 27.0 pg/mL | Standard Deviation 14.1 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-12 P40/P35 Heterodimer (IL-12P70) | Week 8 (n=4, 6, 2, 5, 3) | 0.0 pg/mL | Standard Deviation 0 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-12 P40/P35 Heterodimer (IL-12P70) | Week 8 (n=4, 6, 2, 5, 3) | 1.6 pg/mL | Standard Deviation 38.4 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-12 P40/P35 Heterodimer (IL-12P70) | Week 4 (n=4, 5, 2, 4, 3) | -17.0 pg/mL | Standard Deviation 24.9 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-12 P40/P35 Heterodimer (IL-12P70) | Week 4 (n=4, 5, 2, 4, 3) | 3.7 pg/mL | Standard Deviation 22.7 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-12 P40/P35 Heterodimer (IL-12P70) | Week 8 (n=4, 6, 2, 5, 3) | 31.7 pg/mL | Standard Deviation 23.6 |
Other Pre-specified
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-17A
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time frame: Baseline, Week 4 and 8
Population: A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-17A | Week 4 (n=4, 5, 2, 4, 3) | 1.98 pg/mL | Standard Deviation 5.47 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-17A | Week 8 (n=4, 6, 2, 5, 3) | -1.18 pg/mL | Standard Deviation 1.39 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-17A | Week 4 (n=4, 5, 2, 4, 3) | -2.08 pg/mL | Standard Deviation 4.28 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-17A | Week 8 (n=4, 6, 2, 5, 3) | 0.88 pg/mL | Standard Deviation 4.75 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-17A | Week 4 (n=4, 5, 2, 4, 3) | 1.95 pg/mL | Standard Deviation 2.76 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-17A | Week 8 (n=4, 6, 2, 5, 3) | 0.00 pg/mL | Standard Deviation 0 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-17A | Week 8 (n=4, 6, 2, 5, 3) | -3.58 pg/mL | Standard Deviation 8.01 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-17A | Week 4 (n=4, 5, 2, 4, 3) | -4.30 pg/mL | Standard Deviation 9.4 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-17A | Week 4 (n=4, 5, 2, 4, 3) | 1.60 pg/mL | Standard Deviation 1.44 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-17A | Week 8 (n=4, 6, 2, 5, 3) | 3.93 pg/mL | Standard Deviation 4.61 |
Other Pre-specified
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-18
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time frame: Baseline, Week 4 and 8
Population: A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-18 | Week 4 (n=4, 5, 2, 4, 3) | 247.5 pg/mL | Standard Deviation 374.7 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-18 | Week 8 (n=4, 6, 2, 5, 3) | -81.3 pg/mL | Standard Deviation 110.7 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-18 | Week 4 (n=4, 5, 2, 4, 3) | -73.0 pg/mL | Standard Deviation 57.6 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-18 | Week 8 (n=4, 6, 2, 5, 3) | -6.0 pg/mL | Standard Deviation 186.1 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-18 | Week 4 (n=4, 5, 2, 4, 3) | 146.0 pg/mL | Standard Deviation 206.5 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-18 | Week 8 (n=4, 6, 2, 5, 3) | 100.0 pg/mL | Standard Deviation 43.8 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-18 | Week 8 (n=4, 6, 2, 5, 3) | 18.0 pg/mL | Standard Deviation 210.9 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-18 | Week 4 (n=4, 5, 2, 4, 3) | -154.6 pg/mL | Standard Deviation 287.3 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-18 | Week 4 (n=4, 5, 2, 4, 3) | 22.5 pg/mL | Standard Deviation 57.1 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-18 | Week 8 (n=4, 6, 2, 5, 3) | 51.2 pg/mL | Standard Deviation 27 |
Other Pre-specified
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Beta
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time frame: Baseline, Week 4 and 8
Population: A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Beta | Week 4 (n=4, 5, 2, 4, 3) | -0.05 pg/mL | Standard Deviation 1.6 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Beta | Week 8 (n=4, 6, 2, 5, 3) | -0.70 pg/mL | Standard Deviation 4.97 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Beta | Week 4 (n=4, 5, 2, 4, 3) | -1.42 pg/mL | Standard Deviation 5.22 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Beta | Week 8 (n=4, 6, 2, 5, 3) | -0.42 pg/mL | Standard Deviation 5.84 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Beta | Week 4 (n=4, 5, 2, 4, 3) | 2.75 pg/mL | Standard Deviation 0.35 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Beta | Week 8 (n=4, 6, 2, 5, 3) | 6.00 pg/mL | Standard Deviation 8.49 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Beta | Week 8 (n=4, 6, 2, 5, 3) | -2.14 pg/mL | Standard Deviation 7.88 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Beta | Week 4 (n=4, 5, 2, 4, 3) | -4.93 pg/mL | Standard Deviation 10.29 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Beta | Week 4 (n=4, 5, 2, 4, 3) | 6.03 pg/mL | Standard Deviation 8.54 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Beta | Week 8 (n=4, 6, 2, 5, 3) | 2.03 pg/mL | Standard Deviation 0.15 |
Other Pre-specified
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Receptor Antagonist
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time frame: Baseline, Week 4 and 8
Population: A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Receptor Antagonist | Week 4 (n=3, 5, 2, 4, 3) | 76500.0 pg/mL | Standard Deviation 363953.6 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Receptor Antagonist | Week 8 (n=4, 6, 2, 5, 2) | -256000.0 pg/mL | Standard Deviation 451986 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Receptor Antagonist | Week 4 (n=3, 5, 2, 4, 3) | -172800.0 pg/mL | Standard Deviation 256165.4 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Receptor Antagonist | Week 8 (n=4, 6, 2, 5, 2) | 153833.3 pg/mL | Standard Deviation 317150.7 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Receptor Antagonist | Week 4 (n=3, 5, 2, 4, 3) | 269500.0 pg/mL | Standard Deviation 498510.3 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Receptor Antagonist | Week 8 (n=4, 6, 2, 5, 2) | 200000.0 pg/mL | Standard Deviation 144249.8 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Receptor Antagonist | Week 8 (n=4, 6, 2, 5, 2) | -268260.0 pg/mL | Standard Deviation 546901.3 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Receptor Antagonist | Week 4 (n=3, 5, 2, 4, 3) | -370575.0 pg/mL | Standard Deviation 647507.1 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Receptor Antagonist | Week 4 (n=3, 5, 2, 4, 3) | 15600.0 pg/mL | Standard Deviation 156124.6 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Receptor Antagonist | Week 8 (n=4, 6, 2, 5, 2) | 397550.0 pg/mL | Standard Deviation 621476.1 |
Other Pre-specified
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-23
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time frame: Baseline, Week 4 and 8
Population: A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-23 | Week 4 (n=4, 5, 2, 4, 3) | 3.15 ng/mL | Standard Deviation 6.14 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-23 | Week 8 (n=4, 6, 2, 5, 3) | -6.78 ng/mL | Standard Deviation 18.62 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-23 | Week 4 (n=4, 5, 2, 4, 3) | -13.80 ng/mL | Standard Deviation 22.14 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-23 | Week 8 (n=4, 6, 2, 5, 3) | 3.60 ng/mL | Standard Deviation 16.65 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-23 | Week 4 (n=4, 5, 2, 4, 3) | 8.00 ng/mL | Standard Deviation 21.21 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-23 | Week 8 (n=4, 6, 2, 5, 3) | -4.00 ng/mL | Standard Deviation 9.9 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-23 | Week 8 (n=4, 6, 2, 5, 3) | 0.60 ng/mL | Standard Deviation 6.02 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-23 | Week 4 (n=4, 5, 2, 4, 3) | -7.13 ng/mL | Standard Deviation 19.21 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-23 | Week 4 (n=4, 5, 2, 4, 3) | 2.73 ng/mL | Standard Deviation 3.04 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-23 | Week 8 (n=4, 6, 2, 5, 3) | 0.00 ng/mL | Standard Deviation 0 |
Other Pre-specified
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-6
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time frame: Baseline, Week 4 and 8
Population: A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-6 | Week 4 (n=4, 5, 2, 4, 3) | 76.00 pg/mL | Standard Deviation 140.92 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-6 | Week 8 (n=4, 6, 2, 5, 3) | -11.00 pg/mL | Standard Deviation 23.35 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-6 | Week 4 (n=4, 5, 2, 4, 3) | -36.80 pg/mL | Standard Deviation 48.75 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-6 | Week 8 (n=4, 6, 2, 5, 3) | 4.00 pg/mL | Standard Deviation 25.49 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-6 | Week 4 (n=4, 5, 2, 4, 3) | 22.50 pg/mL | Standard Deviation 21.92 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-6 | Week 8 (n=4, 6, 2, 5, 3) | 139.00 pg/mL | Standard Deviation 192.33 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-6 | Week 8 (n=4, 6, 2, 5, 3) | 25.80 pg/mL | Standard Deviation 141.39 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-6 | Week 4 (n=4, 5, 2, 4, 3) | -19.70 pg/mL | Standard Deviation 126.34 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-6 | Week 4 (n=4, 5, 2, 4, 3) | 16.33 pg/mL | Standard Deviation 34.7 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-6 | Week 8 (n=4, 6, 2, 5, 3) | 12.00 pg/mL | Standard Deviation 14 |
Other Pre-specified
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-7
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time frame: Baseline, Week 4 and 8
Population: A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-7 | Week 4 (n=4, 5, 2, 4, 3) | 35.8 pg/mL | Standard Deviation 51.6 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-7 | Week 8 (n=4, 6, 2, 5, 3) | 14.3 pg/mL | Standard Deviation 16.7 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-7 | Week 4 (n=4, 5, 2, 4, 3) | -6.8 pg/mL | Standard Deviation 38.8 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-7 | Week 8 (n=4, 6, 2, 5, 3) | 19.5 pg/mL | Standard Deviation 30.9 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-7 | Week 4 (n=4, 5, 2, 4, 3) | 28.0 pg/mL | Standard Deviation 22.6 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-7 | Week 8 (n=4, 6, 2, 5, 3) | -15.0 pg/mL | Standard Deviation 8.5 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-7 | Week 8 (n=4, 6, 2, 5, 3) | -16.4 pg/mL | Standard Deviation 28.6 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-7 | Week 4 (n=4, 5, 2, 4, 3) | 3.5 pg/mL | Standard Deviation 73.6 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-7 | Week 4 (n=4, 5, 2, 4, 3) | 10.0 pg/mL | Standard Deviation 50.7 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-7 | Week 8 (n=4, 6, 2, 5, 3) | 25.0 pg/mL | Standard Deviation 16.5 |
Other Pre-specified
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-8
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time frame: Baseline, Week 4 and 8
Population: A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-8 | Week 4 (n=4, 5, 2, 4, 3) | 365.0 pg/mL | Standard Deviation 348.2 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-8 | Week 8 (n=4, 6, 2, 5, 3) | -2486.3 pg/mL | Standard Deviation 4656.3 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-8 | Week 4 (n=4, 5, 2, 4, 3) | -18.8 pg/mL | Standard Deviation 739.1 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-8 | Week 8 (n=4, 6, 2, 5, 3) | -367.8 pg/mL | Standard Deviation 961.9 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-8 | Week 4 (n=4, 5, 2, 4, 3) | -7.0 pg/mL | Standard Deviation 470.9 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-8 | Week 8 (n=4, 6, 2, 5, 3) | -112.5 pg/mL | Standard Deviation 484.4 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-8 | Week 8 (n=4, 6, 2, 5, 3) | -471.6 pg/mL | Standard Deviation 2378.4 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-8 | Week 4 (n=4, 5, 2, 4, 3) | -1057.3 pg/mL | Standard Deviation 1954.2 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-8 | Week 4 (n=4, 5, 2, 4, 3) | 564.3 pg/mL | Standard Deviation 1171.8 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-8 | Week 8 (n=4, 6, 2, 5, 3) | 305.7 pg/mL | Standard Deviation 361.9 |
Other Pre-specified
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Lipocalin 1
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time frame: Baseline, Week 4 and 8
Population: A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Lipocalin 1 | Week 4 (n=4, 5, 2, 4, 3) | -17.00 mcg/mL | Standard Deviation 2539.88 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Lipocalin 1 | Week 8 (n=4, 6, 2, 5, 3) | -1524.50 mcg/mL | Standard Deviation 2083.82 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Lipocalin 1 | Week 4 (n=4, 5, 2, 4, 3) | 257.00 mcg/mL | Standard Deviation 382.18 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Lipocalin 1 | Week 8 (n=4, 6, 2, 5, 3) | 588.67 mcg/mL | Standard Deviation 1504.14 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Lipocalin 1 | Week 4 (n=4, 5, 2, 4, 3) | -3115.50 mcg/mL | Standard Deviation 4418.71 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Lipocalin 1 | Week 8 (n=4, 6, 2, 5, 3) | -3560.00 mcg/mL | Standard Deviation 5048.74 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Lipocalin 1 | Week 8 (n=4, 6, 2, 5, 3) | 222.60 mcg/mL | Standard Deviation 1420.46 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Lipocalin 1 | Week 4 (n=4, 5, 2, 4, 3) | -651.00 mcg/mL | Standard Deviation 659.5 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Lipocalin 1 | Week 4 (n=4, 5, 2, 4, 3) | 573.00 mcg/mL | Standard Deviation 8434.01 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Lipocalin 1 | Week 8 (n=4, 6, 2, 5, 3) | -417.00 mcg/mL | Standard Deviation 4540.91 |
Other Pre-specified
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-3
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time frame: Baseline, Week 4 and 8
Population: A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-3 | Week 4 (n=4, 5, 2, 4, 3) | 2.675 ng/mL | Standard Deviation 5.952 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-3 | Week 8 (n=4, 6, 2, 5, 3) | 21.205 ng/mL | Standard Deviation 42.696 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-3 | Week 4 (n=4, 5, 2, 4, 3) | -1.948 ng/mL | Standard Deviation 3.682 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-3 | Week 8 (n=4, 6, 2, 5, 3) | -0.517 ng/mL | Standard Deviation 3.527 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-3 | Week 4 (n=4, 5, 2, 4, 3) | -0.470 ng/mL | Standard Deviation 1.598 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-3 | Week 8 (n=4, 6, 2, 5, 3) | -0.650 ng/mL | Standard Deviation 0.919 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-3 | Week 8 (n=4, 6, 2, 5, 3) | -14.476 ng/mL | Standard Deviation 31.07 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-3 | Week 4 (n=4, 5, 2, 4, 3) | -24.833 ng/mL | Standard Deviation 48.019 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-3 | Week 4 (n=4, 5, 2, 4, 3) | 0.957 ng/mL | Standard Deviation 1.202 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-3 | Week 8 (n=4, 6, 2, 5, 3) | 0.203 ng/mL | Standard Deviation 0.313 |
Other Pre-specified
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-9
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time frame: Baseline, Week 4 and 8
Population: A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-9 | Week 4 (n=4, 5, 2, 4, 3) | 22.3 ng/mL | Standard Deviation 35.8 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-9 | Week 8 (n=4, 6, 2, 5, 3) | 0.0 ng/mL | Standard Deviation 0 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-9 | Week 4 (n=4, 5, 2, 4, 3) | -13.2 ng/mL | Standard Deviation 29.5 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-9 | Week 8 (n=4, 6, 2, 5, 3) | 57.0 ng/mL | Standard Deviation 90.1 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-9 | Week 4 (n=4, 5, 2, 4, 3) | 8.5 ng/mL | Standard Deviation 12 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-9 | Week 8 (n=4, 6, 2, 5, 3) | 37.5 ng/mL | Standard Deviation 53 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-9 | Week 8 (n=4, 6, 2, 5, 3) | -41.2 ng/mL | Standard Deviation 46.7 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-9 | Week 4 (n=4, 5, 2, 4, 3) | -88.3 ng/mL | Standard Deviation 120.8 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-9 | Week 4 (n=4, 5, 2, 4, 3) | 35.0 ng/mL | Standard Deviation 60.6 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-9 | Week 8 (n=4, 6, 2, 5, 3) | 26.7 ng/mL | Standard Deviation 69 |
Other Pre-specified
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Monocyte Chemotactic Protein 1
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time frame: Baseline, Week 4 and 8
Population: A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Monocyte Chemotactic Protein 1 | Week 4 (n=4, 5, 2, 4, 3) | -168.5 pg/mL | Standard Deviation 265.3 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Monocyte Chemotactic Protein 1 | Week 8 (n=4, 6, 2, 5, 3) | -179.3 pg/mL | Standard Deviation 144.1 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Monocyte Chemotactic Protein 1 | Week 4 (n=4, 5, 2, 4, 3) | -438.8 pg/mL | Standard Deviation 962.4 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Monocyte Chemotactic Protein 1 | Week 8 (n=4, 6, 2, 5, 3) | -289.7 pg/mL | Standard Deviation 1205.3 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Monocyte Chemotactic Protein 1 | Week 4 (n=4, 5, 2, 4, 3) | 24.5 pg/mL | Standard Deviation 79.9 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Monocyte Chemotactic Protein 1 | Week 8 (n=4, 6, 2, 5, 3) | -169.5 pg/mL | Standard Deviation 217.1 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Monocyte Chemotactic Protein 1 | Week 8 (n=4, 6, 2, 5, 3) | 28.2 pg/mL | Standard Deviation 431 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Monocyte Chemotactic Protein 1 | Week 4 (n=4, 5, 2, 4, 3) | -468.0 pg/mL | Standard Deviation 390.6 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Monocyte Chemotactic Protein 1 | Week 4 (n=4, 5, 2, 4, 3) | 26.7 pg/mL | Standard Deviation 63.1 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Monocyte Chemotactic Protein 1 | Week 8 (n=4, 6, 2, 5, 3) | -14.3 pg/mL | Standard Deviation 33.9 |
Other Pre-specified
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 1
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time frame: Baseline, Week 4 and 8
Population: A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 1 | Week 4 (n=4, 5, 2, 4, 3) | 41.0 Relative unit/mL | Standard Deviation 35.6 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 1 | Week 8 (n=4, 6, 2, 5, 3) | -97.0 Relative unit/mL | Standard Deviation 183 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 1 | Week 4 (n=4, 5, 2, 4, 3) | 194.8 Relative unit/mL | Standard Deviation 428.5 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 1 | Week 8 (n=4, 6, 2, 5, 3) | 33.5 Relative unit/mL | Standard Deviation 124.2 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 1 | Week 4 (n=4, 5, 2, 4, 3) | 79.5 Relative unit/mL | Standard Deviation 89.8 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 1 | Week 8 (n=4, 6, 2, 5, 3) | 30.5 Relative unit/mL | Standard Deviation 57.3 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 1 | Week 8 (n=4, 6, 2, 5, 3) | -80.2 Relative unit/mL | Standard Deviation 200.1 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 1 | Week 4 (n=4, 5, 2, 4, 3) | -328.5 Relative unit/mL | Standard Deviation 634.9 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 1 | Week 4 (n=4, 5, 2, 4, 3) | -5.3 Relative unit/mL | Standard Deviation 23.5 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 1 | Week 8 (n=4, 6, 2, 5, 3) | -15.3 Relative unit/mL | Standard Deviation 23.2 |
Other Pre-specified
Change in the Biomarker in Tear Fluid for Study Eye From Baseline - Mucin 16 Carbohydrate Antigen 125
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time frame: Baseline, Week 4 and 8
Population: A subset of Intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline - Mucin 16 Carbohydrate Antigen 125 | Week 4 (n=4, 5, 2, 4, 3) | 44.8 Relative unit/mL | Standard Deviation 337.3 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline - Mucin 16 Carbohydrate Antigen 125 | Week 8 (n=4, 6, 2, 5, 3) | -487.3 Relative unit/mL | Standard Deviation 364 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline - Mucin 16 Carbohydrate Antigen 125 | Week 4 (n=4, 5, 2, 4, 3) | -228.6 Relative unit/mL | Standard Deviation 1493.7 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline - Mucin 16 Carbohydrate Antigen 125 | Week 8 (n=4, 6, 2, 5, 3) | 4.0 Relative unit/mL | Standard Deviation 910.5 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline - Mucin 16 Carbohydrate Antigen 125 | Week 4 (n=4, 5, 2, 4, 3) | -41.0 Relative unit/mL | Standard Deviation 312.5 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline - Mucin 16 Carbohydrate Antigen 125 | Week 8 (n=4, 6, 2, 5, 3) | 265.5 Relative unit/mL | Standard Deviation 685.2 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline - Mucin 16 Carbohydrate Antigen 125 | Week 8 (n=4, 6, 2, 5, 3) | -427.6 Relative unit/mL | Standard Deviation 1479.9 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline - Mucin 16 Carbohydrate Antigen 125 | Week 4 (n=4, 5, 2, 4, 3) | -648.5 Relative unit/mL | Standard Deviation 1710.9 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline - Mucin 16 Carbohydrate Antigen 125 | Week 4 (n=4, 5, 2, 4, 3) | 130.0 Relative unit/mL | Standard Deviation 178 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline - Mucin 16 Carbohydrate Antigen 125 | Week 8 (n=4, 6, 2, 5, 3) | -289.3 Relative unit/mL | Standard Deviation 86.8 |
Other Pre-specified
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 5AC
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time frame: Baseline, Week 4 and 8
Population: A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 5AC | Week 4 (n=3, 5, 2, 4, 3) | 1704.00 Relative unit/mL | Standard Deviation 4222.07 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 5AC | Week 8 (n=4, 6, 2, 5, 3) | -18222.00 Relative unit/mL | Standard Deviation 32490.62 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 5AC | Week 4 (n=3, 5, 2, 4, 3) | -871.40 Relative unit/mL | Standard Deviation 4857.15 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 5AC | Week 8 (n=4, 6, 2, 5, 3) | 487.83 Relative unit/mL | Standard Deviation 5164.47 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 5AC | Week 4 (n=3, 5, 2, 4, 3) | 383.00 Relative unit/mL | Standard Deviation 24.04 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 5AC | Week 8 (n=4, 6, 2, 5, 3) | 6926.00 Relative unit/mL | Standard Deviation 10004.15 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 5AC | Week 8 (n=4, 6, 2, 5, 3) | -35105.40 Relative unit/mL | Standard Deviation 84919.27 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 5AC | Week 4 (n=3, 5, 2, 4, 3) | -35221.50 Relative unit/mL | Standard Deviation 67264.76 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 5AC | Week 4 (n=3, 5, 2, 4, 3) | 1651.67 Relative unit/mL | Standard Deviation 7544.36 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 5AC | Week 8 (n=4, 6, 2, 5, 3) | -1698.33 Relative unit/mL | Standard Deviation 2346.05 |
Other Pre-specified
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Tissue Inhibitor of Metalloproteinase 1 (TIMP-1)
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time frame: Baseline, Week 4 and 8
Population: A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Tissue Inhibitor of Metalloproteinase 1 (TIMP-1) | Week 4 (n=4, 5, 2, 4, 3) | 12.5 ng/mL | Standard Deviation 85.9 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Tissue Inhibitor of Metalloproteinase 1 (TIMP-1) | Week 8 (n=4, 6, 2, 5, 3) | -48.5 ng/mL | Standard Deviation 69.8 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Tissue Inhibitor of Metalloproteinase 1 (TIMP-1) | Week 4 (n=4, 5, 2, 4, 3) | -19.8 ng/mL | Standard Deviation 73.5 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Tissue Inhibitor of Metalloproteinase 1 (TIMP-1) | Week 8 (n=4, 6, 2, 5, 3) | 34.3 ng/mL | Standard Deviation 75.2 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Tissue Inhibitor of Metalloproteinase 1 (TIMP-1) | Week 4 (n=4, 5, 2, 4, 3) | 124.5 ng/mL | Standard Deviation 173.2 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Tissue Inhibitor of Metalloproteinase 1 (TIMP-1) | Week 8 (n=4, 6, 2, 5, 3) | -109.0 ng/mL | Standard Deviation 168.3 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Tissue Inhibitor of Metalloproteinase 1 (TIMP-1) | Week 8 (n=4, 6, 2, 5, 3) | -76.8 ng/mL | Standard Deviation 88.1 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Tissue Inhibitor of Metalloproteinase 1 (TIMP-1) | Week 4 (n=4, 5, 2, 4, 3) | -131.8 ng/mL | Standard Deviation 165.9 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Tissue Inhibitor of Metalloproteinase 1 (TIMP-1) | Week 4 (n=4, 5, 2, 4, 3) | 142.3 ng/mL | Standard Deviation 375.9 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Tissue Inhibitor of Metalloproteinase 1 (TIMP-1) | Week 8 (n=4, 6, 2, 5, 3) | 114.0 ng/mL | Standard Deviation 167.7 |
Other Pre-specified
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Total Protein
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time frame: Baseline, Week 4 and 8
Population: A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Total Protein | Week 4 (n=4, 5, 2, 4, 3) | 748.8 mcg/mL | Standard Deviation 4116.3 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Total Protein | Week 8 (n=4, 6, 2, 5, 3) | -2322.5 mcg/mL | Standard Deviation 4827.1 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Total Protein | Week 4 (n=4, 5, 2, 4, 3) | -956.0 mcg/mL | Standard Deviation 4190.6 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Total Protein | Week 8 (n=4, 6, 2, 5, 3) | 836.7 mcg/mL | Standard Deviation 4104.5 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Total Protein | Week 4 (n=4, 5, 2, 4, 3) | 1180.0 mcg/mL | Standard Deviation 311.1 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Total Protein | Week 8 (n=4, 6, 2, 5, 3) | -5695.0 mcg/mL | Standard Deviation 8605.5 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Total Protein | Week 8 (n=4, 6, 2, 5, 3) | -3070.0 mcg/mL | Standard Deviation 4798.4 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Total Protein | Week 4 (n=4, 5, 2, 4, 3) | -8281.3 mcg/mL | Standard Deviation 13425.6 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Total Protein | Week 4 (n=4, 5, 2, 4, 3) | 6328.3 mcg/mL | Standard Deviation 17461.8 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Total Protein | Week 8 (n=4, 6, 2, 5, 3) | 5195.0 mcg/mL | Standard Deviation 9724.4 |
Other Pre-specified
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Vascular Endothelial Growth Factor
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time frame: Baseline, Week 4 and 8
Population: A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Vascular Endothelial Growth Factor | Week 4 (n=4, 5, 2, 4, 3) | 152.5 pg/mL | Standard Deviation 1620.5 |
| CP-690,550 Eye Drops Vehicle Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Vascular Endothelial Growth Factor | Week 8 (n=4, 6, 2, 5, 3) | -1812.5 pg/mL | Standard Deviation 1477.6 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Vascular Endothelial Growth Factor | Week 4 (n=4, 5, 2, 4, 3) | -942.0 pg/mL | Standard Deviation 2466.2 |
| CP-690,550 Eye Drops 0.001% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Vascular Endothelial Growth Factor | Week 8 (n=4, 6, 2, 5, 3) | 790.0 pg/mL | Standard Deviation 1639.2 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Vascular Endothelial Growth Factor | Week 4 (n=4, 5, 2, 4, 3) | 840.0 pg/mL | Standard Deviation 735.4 |
| CP-690,550 Eye Drops 0.003% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Vascular Endothelial Growth Factor | Week 8 (n=4, 6, 2, 5, 3) | -910.0 pg/mL | Standard Deviation 2588 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Vascular Endothelial Growth Factor | Week 8 (n=4, 6, 2, 5, 3) | 734.0 pg/mL | Standard Deviation 3267.6 |
| CP-690,550 Eye Drops 0.005% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Vascular Endothelial Growth Factor | Week 4 (n=4, 5, 2, 4, 3) | -1486.5 pg/mL | Standard Deviation 4486.5 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Vascular Endothelial Growth Factor | Week 4 (n=4, 5, 2, 4, 3) | 546.7 pg/mL | Standard Deviation 546.4 |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Vascular Endothelial Growth Factor | Week 8 (n=4, 6, 2, 5, 3) | -699.3 pg/mL | Standard Deviation 1094.8 |
Other Pre-specified
Number of Participants Evaluated for Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 4
Number of analyzed with sufficient quantity for analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Time frame: Week 4 and 8
Population: A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 Eye Drops Vehicle Group in Japan | Number of Participants Evaluated for Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 4 | Week 4 | 2 Participants |
| CP-690,550 Eye Drops Vehicle Group in Japan | Number of Participants Evaluated for Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 4 | Week 8 | 0 Participants |
| CP-690,550 Eye Drops 0.001% Group in Japan | Number of Participants Evaluated for Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 4 | Week 4 | 2 Participants |
| CP-690,550 Eye Drops 0.001% Group in Japan | Number of Participants Evaluated for Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 4 | Week 8 | 2 Participants |
| CP-690,550 Eye Drops 0.003% Group in Japan | Number of Participants Evaluated for Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 4 | Week 4 | 1 Participants |
| CP-690,550 Eye Drops 0.003% Group in Japan | Number of Participants Evaluated for Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 4 | Week 8 | 1 Participants |
| CP-690,550 Eye Drops 0.005% Group in Japan | Number of Participants Evaluated for Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 4 | Week 8 | 1 Participants |
| CP-690,550 Eye Drops 0.005% Group in Japan | Number of Participants Evaluated for Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 4 | Week 4 | 1 Participants |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Number of Participants Evaluated for Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 4 | Week 4 | 1 Participants |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | Number of Participants Evaluated for Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 4 | Week 8 | 1 Participants |