Dry Eye Syndromes
Conditions
Keywords
Dry eye
Brief summary
A prospective, randomized, placebo and active comparator controlled study of CP-690,550 in subjects with dry eye.
Interventions
DRUGCP-690,550
Ophthalmic topical solution, low dose, dosed at least once/day, 8 weeks
DRUGCyclosporine
Ophthalmic topical solution, 0.05%, dosed at least once/day, 8 weeks
DRUGCP-690,550 Vehicle
Ophthalmic topical solution, dosed at least once/day, 8 weeks
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Symptoms of dry eye for at least 6 months. * Signs of moderate to severe dry eye
Exclusion criteria
* Women who are nursing or pregnant * 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 |
|---|---|---|
| Percentage of Participants With Systemic Adverse Events (AEs) | Baseline up to Week 8 | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Systemic AEs are the events which are not localized but occur throughout the systemic circulation. |
| Percentage of Participants With Ocular Adverse Events (AEs) | Baseline up to Week 8 | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Ocular AEs are the events which are localized in the ocular region. |
| Percentage of Participants With Ocular Tolerability Assessment | Baseline up to Week 8 | Ocular tolerability assessment included evaluation of severity and duration of the 5 symptoms: burning/stinging, blurred vision, ocular discomfort, pain, tearing. Severity was assessed on a 4-point scale, where 0=none, 1=mild, 2=moderate and 3=severe. Duration was assessed as immediate (if subsided within 5 minutes \[\<5 min\] after application) or persistent (if continued beyond 5 minutes \[\>=5 min\] after application). |
| Percentage of Participants Who Achieved Greater Than or Equal to (>=) 10 Millimeter (mm) Schirmer Wetting Score Without Anesthesia at Week 8 | Week 8 | Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 millimeter (mm). If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Schirmer Wetting Score With Anesthesia at Week 8 | Baseline, Week 8 | Schirmer test was performed 2 to 3 minutes after 1 drop of proparacaine 0.5% was placed in lower conjunctival fornix and superior bulbar conjunctiva of each eye. It was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline. |
| Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4 and 6 | Week 1, 2, 4, 6 | Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline. |
| Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score With Anesthesia at Week 8 | Week 8 | Schirmer test was performed 2 to 3 minutes after 1 drop of proparacaine 0.5% was placed in lower conjunctival fornix and superior bulbar conjunctiva of each eye. It was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline. |
| Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8 | Baseline, Week 1, 2, 4, 6, 8 | Corneal staining was assessed using fluorescein dye, a yellow filter, and a slit lamp. The cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale; where 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. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline. |
| Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining | Week 1, 2, 4, 6, 8 | Corneal staining was assessed using fluorescein dye, yellow filter, slit lamp. Cornea was divided into 5 different zones. Each corneal zone was graded independently using 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. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline. |
| Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8 | Baseline, Week 1, 2, 4, 6, 8 | Interpalpebral conjunctival staining was performed 1 minute following ocular administration of lissamine green dye with aid of slit lamp. Based on Oxford grading system, bulbar conjunctiva was divided into 2 zones: nasal, temporal. Staining were graded using a 6-point scale (0=absent, 5=severe). Total score=sum of 2 zone scores. Total score range: 0 to 10, higher score=higher damage to eyes due to dryness. Negative change from baseline indicated improvement. Results from study eye are reported. Study eye is the eye with worse Schirmer test score without anesthesia score at baseline. |
| Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8 | Baseline, Week 1, 2, 4, 6, 8 | TBUT was the time interval between the last complete blink and the first appearance of a dry spot, or disruption in the tear film. It was measured under a slit lamp following instillation of fluorescein dye in the eye using a stopwatch. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline. |
| Time to Achieve >= 10mm Schirmer Test Score Without Anesthesia | Baseline through Week 8 | Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline. |
| Percentage of Participants With >= 5 Units Decrease in Total OCI Score | Week 1, 2, 4, 6, 8 | OCI: validated questionnaire 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 Likert scale ranging from 0 (never) to 6 (always/severe). Total score was transformed to range of 0 to 100, higher score indicated more ocular discomfort. |
| Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8 | Baseline, Week 1, 2, 4, 6, 8 | Daily artificial tear use was assessed by collecting data on daily number of drops of artificial tear instilled in the eye using a participant diary. Decrease in daily artificial tear use indicated improvement. |
| Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Baseline, Week 1, 2, 4, 6, 8 | OSDI is a validated instrument for ocular surface disease. It has 12 items, each measured on 5-point Likert scale (0=none of the time, 4=all the time). Based on these item scores, a total OSDI score (question 1 \[Q1\]-Q12) and three subscale scores can be derived: Ocular Symptom (Q1-Q3), Vision-related function (Q4-Q9), and Environmental trigger (Q10-Q12). Each derived score ranges from 0 to 100, with a higher score indicates worse condition. |
| Percentage of Participants With >= 10 Units Decrease in Total OSDI Score | Week 1, 2, 4, 6, 8 | OSDI is a validated instrument for ocular surface disease. It has 12 items, each has a raw score measured on 5-point Likert scale (0=none of the time, 4=all the time). Based on these item scores, a total OSDI score can be derived which ranges from 0 to 100; a higher score indicates worse ocular disease. |
| Change From Baseline Ocular Surface Disease Index (OSDI) Raw Score at Week 1, 2, 4, 6 and 8 | Baseline, Week 1, 2, 4, 6, 8 | OSDI is a validated instrument for ocular surface disease. It has 12 items, each with a raw score measured on 5-point Likert scale (0=none of the time, 4=all the time). |
| Change From Baseline in Modified Ocular Comfort Index (mOCI) Raw Scores at Week 1, 2, 4, 6 and 8 | Baseline, Week 1, 2, 4, 6, 8 | mOCI consisted of the original 12-item OCI plus additional questions on other dry eye symptoms and their impact to participant's life. Each item was measured on a 7-point Likert scale ranging from 0 (never) to 6 (always/severe). Negative change from baseline indicated improvement. |
| Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline, Week 8 | NEI-VFQ-25 questionnaire included 25 items based on which overall composite VFQ score and 12 subscales were derived: general health (GH), general vision (GV), ocular pain (OP), near activities (NAct), distance activities (DA), social functioning (SF), mental health (MH), role difficulties (RD), dependency, driving, color vision (CV) and peripheral vision (PV). Response to each question converted to 0-100 score. Each subscale, total score=average of items contributing to score. For each subscale and total score, score range: 0 to 100, higher score=less symptoms/better visual functioning. |
| Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8 | Baseline, Week 1, 2, 4, 6, 8 | OCI: validated questionnaire 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 Likert scale ranging from 0 (never) to 6 (always/severe). Total score was transformed to range of 0 to 100, higher score indicated more ocular discomfort. Negative change from baseline indicated improvement. |
| Time to Achieve 100 Percent (%) Clearance of Corneal Staining | Baseline through Week 8 | Corneal staining was assessed by instilling sodium fluorescein dye in the eye and after 1 to 2 minutes, observing for corneal staining with the aid of a yellow filter and slit lamp. The cornea was divided into five different zones and each corneal zone was graded independently using a 0 to 3 grading scale; where 0=none, 1=slight, 2=moderate, 3=severe. Results from study eye were to be reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline. |
| Time to Achieve >= 5 Units Decrease in Ocular Comfort Index (OCI) Score | Baseline through Week 8 | OCI: validated questionnaire to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contained 12 questions, each measured on a 7-point Likert scale ranging from 0 (never) to 6 (always/severe). Total score was transformed to range of 0 to 100, higher score indicated more ocular discomfort. Negative change from baseline indicated improvement. |
| Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8 | Baseline, Week 1, 2, 4, 6, 8 | Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Twice Daily One drop (45 microliter \[mcL\]) of matching placebo solution twice daily in each eye for 8 weeks. | 47 |
| CP-690,550, 0.0003% Twice Daily One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks. | 46 |
| CP-690,550, 0.001% Twice Daily One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks. | 47 |
| CP-690,550, 0.003% Twice Daily One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks. | 48 |
| CP-690,550, 0.005% Twice Daily One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks. | 48 |
| CP-690,550, 0.005% Once Daily One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks. | 44 |
| Restasis Twice Daily One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks. | 47 |
| Total | 327 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 | 0 | 0 | 1 | 1 | 1 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 1 | 1 | 0 |
| Overall Study | Other | 2 | 1 | 1 | 0 | 2 | 1 | 3 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 0 | 2 | 0 | 1 |
Baseline characteristics
| Characteristic | CP-690,550, 0.003% Twice Daily | Total | Restasis Twice Daily | CP-690,550, 0.005% Once Daily | CP-690,550, 0.005% Twice Daily | Placebo Twice Daily | CP-690,550, 0.0003% Twice Daily | CP-690,550, 0.001% Twice Daily |
|---|---|---|---|---|---|---|---|---|
| Age Continuous | 58.7 years STANDARD_DEVIATION 14.57 | 60.0 years STANDARD_DEVIATION 13.02 | 58.9 years STANDARD_DEVIATION 14.25 | 59.8 years STANDARD_DEVIATION 14.83 | 59.9 years STANDARD_DEVIATION 11.69 | 62.3 years STANDARD_DEVIATION 12.54 | 59.5 years STANDARD_DEVIATION 11.57 | 60.7 years STANDARD_DEVIATION 11.73 |
| Sex: Female, Male Female | 34 Participants | 255 Participants | 38 Participants | 37 Participants | 39 Participants | 32 Participants | 35 Participants | 40 Participants |
| Sex: Female, Male Male | 14 Participants | 72 Participants | 9 Participants | 7 Participants | 9 Participants | 15 Participants | 11 Participants | 7 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 |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 23 / 47 | 11 / 46 | 22 / 47 | 21 / 48 | 15 / 48 | 15 / 44 | 26 / 47 |
| serious Total, serious adverse events | 0 / 47 | 1 / 46 | 0 / 47 | 1 / 48 | 1 / 48 | 1 / 44 | 1 / 47 |
Outcome results
Primary
Percentage of Participants Who Achieved Greater Than or Equal to (>=) 10 Millimeter (mm) Schirmer Wetting Score Without Anesthesia at Week 8
Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 millimeter (mm). If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
Time frame: Week 8
Population: ITT population included all enrolled participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) was the method used for imputing missing data at Week 8.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Twice Daily | Percentage of Participants Who Achieved Greater Than or Equal to (>=) 10 Millimeter (mm) Schirmer Wetting Score Without Anesthesia at Week 8 | 20.0 percentage of participants |
| CP-690,550, 0.0003% Twice Daily | Percentage of Participants Who Achieved Greater Than or Equal to (>=) 10 Millimeter (mm) Schirmer Wetting Score Without Anesthesia at Week 8 | 17.8 percentage of participants |
| CP-690,550, 0.001% Twice Daily | Percentage of Participants Who Achieved Greater Than or Equal to (>=) 10 Millimeter (mm) Schirmer Wetting Score Without Anesthesia at Week 8 | 25.5 percentage of participants |
| CP-690,550, 0.003% Twice Daily | Percentage of Participants Who Achieved Greater Than or Equal to (>=) 10 Millimeter (mm) Schirmer Wetting Score Without Anesthesia at Week 8 | 18.8 percentage of participants |
| CP-690,550, 0.005% Twice Daily | Percentage of Participants Who Achieved Greater Than or Equal to (>=) 10 Millimeter (mm) Schirmer Wetting Score Without Anesthesia at Week 8 | 26.1 percentage of participants |
| CP-690,550, 0.005% Once Daily | Percentage of Participants Who Achieved Greater Than or Equal to (>=) 10 Millimeter (mm) Schirmer Wetting Score Without Anesthesia at Week 8 | 27.3 percentage of participants |
| Restasis Twice Daily | Percentage of Participants Who Achieved Greater Than or Equal to (>=) 10 Millimeter (mm) Schirmer Wetting Score Without Anesthesia at Week 8 | 35.6 percentage of participants |
Primary
Percentage of Participants With Ocular Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Ocular AEs are the events which are localized in the ocular region.
Time frame: Baseline up to Week 8
Population: ITT population included all enrolled participants who received at least 1 dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Twice Daily | Percentage of Participants With Ocular Adverse Events (AEs) | 25.5 percentage of participants |
| CP-690,550, 0.0003% Twice Daily | Percentage of Participants With Ocular Adverse Events (AEs) | 21.7 percentage of participants |
| CP-690,550, 0.001% Twice Daily | Percentage of Participants With Ocular Adverse Events (AEs) | 31.9 percentage of participants |
| CP-690,550, 0.003% Twice Daily | Percentage of Participants With Ocular Adverse Events (AEs) | 22.9 percentage of participants |
| CP-690,550, 0.005% Twice Daily | Percentage of Participants With Ocular Adverse Events (AEs) | 22.9 percentage of participants |
| CP-690,550, 0.005% Once Daily | Percentage of Participants With Ocular Adverse Events (AEs) | 22.7 percentage of participants |
| Restasis Twice Daily | Percentage of Participants With Ocular Adverse Events (AEs) | 36.2 percentage of participants |
Primary
Percentage of Participants With Ocular Tolerability Assessment
Ocular tolerability assessment included evaluation of severity and duration of the 5 symptoms: burning/stinging, blurred vision, ocular discomfort, pain, tearing. Severity was assessed on a 4-point scale, where 0=none, 1=mild, 2=moderate and 3=severe. Duration was assessed as immediate (if subsided within 5 minutes \[\<5 min\] after application) or persistent (if continued beyond 5 minutes \[\>=5 min\] after application).
Time frame: Baseline up to Week 8
Population: ITT population included all enrolled participants who received at least one dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Blurred vision:moderate/severe, duration >=5 min | 0.0 percentage of participants |
| Placebo Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Pain:mild | 13.3 percentage of participants |
| Placebo Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Burning sensation:moderate | 17.8 percentage of participants |
| Placebo Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Pain:moderate | 4.4 percentage of participants |
| Placebo Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Blurred vision:mild | 40.0 percentage of participants |
| Placebo Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Ocular discomfort:moderate/severe, duration>=5 min | 4.4 percentage of participants |
| Placebo Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Blurred vision:severe | 2.0 percentage of participants |
| Placebo Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Tearing:moderate | 4.4 percentage of participants |
| Placebo Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Ocular discomfort:severe | 0.0 percentage of participants |
| Placebo Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Burning sensation:severe | 0.0 percentage of participants |
| Placebo Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Tearing:mild | 40.0 percentage of participants |
| Placebo Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Blurred vision:moderate | 6.7 percentage of participants |
| Placebo Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Pain:none | 82.2 percentage of participants |
| Placebo Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Burning sensation:moderate/severe,duration>=5 min | 0.0 percentage of participants |
| Placebo Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Ocular discomfort:moderate | 11.1 percentage of participants |
| Placebo Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Pain:severe | 0.0 percentage of participants |
| Placebo Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Ocular discomfort:mild | 33.3 percentage of participants |
| Placebo Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Burning sensation:none | 26.7 percentage of participants |
| Placebo Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Tearing:moderate/severe, duration >= 5 min | 0.0 percentage of participants |
| Placebo Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Burning sensation:mild | 55.6 percentage of participants |
| Placebo Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Ocular discomfort:none | 55.6 percentage of participants |
| Placebo Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Tearing:severe | 0.0 percentage of participants |
| Placebo Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Blurred vision:none | 51.1 percentage of participants |
| Placebo Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Tearing:none | 55.6 percentage of participants |
| Placebo Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Pain:moderate/severe, duration >=5 min | 2.2 percentage of participants |
| CP-690,550, 0.0003% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Ocular discomfort:mild | 28.3 percentage of participants |
| CP-690,550, 0.0003% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Ocular discomfort:severe | 2.2 percentage of participants |
| CP-690,550, 0.0003% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Pain:moderate/severe, duration >=5 min | 0.0 percentage of participants |
| CP-690,550, 0.0003% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Ocular discomfort:moderate/severe, duration>=5 min | 10.9 percentage of participants |
| CP-690,550, 0.0003% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Pain:moderate | 6.5 percentage of participants |
| CP-690,550, 0.0003% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Burning sensation:none | 43.5 percentage of participants |
| CP-690,550, 0.0003% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Tearing:moderate | 10.9 percentage of participants |
| CP-690,550, 0.0003% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Pain:none | 80.4 percentage of participants |
| CP-690,550, 0.0003% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Blurred vision:none | 54.3 percentage of participants |
| CP-690,550, 0.0003% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Tearing:mild | 26.1 percentage of participants |
| CP-690,550, 0.0003% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Blurred vision:mild | 30.4 percentage of participants |
| CP-690,550, 0.0003% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Burning sensation:severe | 2.2 percentage of participants |
| CP-690,550, 0.0003% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Blurred vision:moderate | 15.2 percentage of participants |
| CP-690,550, 0.0003% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Burning sensation:moderate/severe,duration>=5 min | 2.2 percentage of participants |
| CP-690,550, 0.0003% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Tearing:moderate/severe, duration >= 5 min | 2.2 percentage of participants |
| CP-690,550, 0.0003% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Blurred vision:severe | 0.0 percentage of participants |
| CP-690,550, 0.0003% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Pain:severe | 2.2 percentage of participants |
| CP-690,550, 0.0003% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Burning sensation:moderate | 15.2 percentage of participants |
| CP-690,550, 0.0003% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Blurred vision:moderate/severe, duration >=5 min | 2.2 percentage of participants |
| CP-690,550, 0.0003% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Pain:mild | 10.9 percentage of participants |
| CP-690,550, 0.0003% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Ocular discomfort:none | 50.0 percentage of participants |
| CP-690,550, 0.0003% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Tearing:severe | 0.0 percentage of participants |
| CP-690,550, 0.0003% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Tearing:none | 63.0 percentage of participants |
| CP-690,550, 0.0003% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Burning sensation:mild | 39.1 percentage of participants |
| CP-690,550, 0.0003% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Ocular discomfort:moderate | 19.6 percentage of participants |
| CP-690,550, 0.001% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Pain:none | 80.9 percentage of participants |
| CP-690,550, 0.001% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Burning sensation:mild | 59.6 percentage of participants |
| CP-690,550, 0.001% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Blurred vision:moderate/severe, duration >=5 min | 4.3 percentage of participants |
| CP-690,550, 0.001% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Tearing:severe | 0.0 percentage of participants |
| CP-690,550, 0.001% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Blurred vision:none | 53.2 percentage of participants |
| CP-690,550, 0.001% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Tearing:mild | 21.3 percentage of participants |
| CP-690,550, 0.001% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Tearing:none | 68.1 percentage of participants |
| CP-690,550, 0.001% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Tearing:moderate/severe, duration >= 5 min | 6.4 percentage of participants |
| CP-690,550, 0.001% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Burning sensation:none | 23.4 percentage of participants |
| CP-690,550, 0.001% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Ocular discomfort:none | 53.2 percentage of participants |
| CP-690,550, 0.001% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Pain:mild | 8.5 percentage of participants |
| CP-690,550, 0.001% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Pain:moderate | 6.4 percentage of participants |
| CP-690,550, 0.001% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Ocular discomfort:severe | 2.1 percentage of participants |
| CP-690,550, 0.001% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Blurred vision:moderate | 12.8 percentage of participants |
| CP-690,550, 0.001% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Tearing:moderate | 10.6 percentage of participants |
| CP-690,550, 0.001% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Pain:moderate/severe, duration >=5 min | 0.0 percentage of participants |
| CP-690,550, 0.001% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Burning sensation:moderate/severe,duration>=5 min | 2.1 percentage of participants |
| CP-690,550, 0.001% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Burning sensation:moderate | 14.9 percentage of participants |
| CP-690,550, 0.001% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Blurred vision:mild | 34.0 percentage of participants |
| CP-690,550, 0.001% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Ocular discomfort:moderate | 19.1 percentage of participants |
| CP-690,550, 0.001% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Blurred vision:severe | 0.0 percentage of participants |
| CP-690,550, 0.001% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Ocular discomfort:mild | 25.5 percentage of participants |
| CP-690,550, 0.001% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Ocular discomfort:moderate/severe, duration>=5 min | 8.5 percentage of participants |
| CP-690,550, 0.001% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Pain:severe | 4.3 percentage of participants |
| CP-690,550, 0.001% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Burning sensation:severe | 2.1 percentage of participants |
| CP-690,550, 0.003% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Burning sensation:moderate | 22.9 percentage of participants |
| CP-690,550, 0.003% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Pain:none | 85.4 percentage of participants |
| CP-690,550, 0.003% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Pain:mild | 6.3 percentage of participants |
| CP-690,550, 0.003% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Pain:moderate | 6.3 percentage of participants |
| CP-690,550, 0.003% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Blurred vision:none | 58.3 percentage of participants |
| CP-690,550, 0.003% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Tearing:moderate | 10.4 percentage of participants |
| CP-690,550, 0.003% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Blurred vision:mild | 27.1 percentage of participants |
| CP-690,550, 0.003% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Blurred vision:moderate | 8.3 percentage of participants |
| CP-690,550, 0.003% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Blurred vision:severe | 6.3 percentage of participants |
| CP-690,550, 0.003% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Tearing:none | 72.9 percentage of participants |
| CP-690,550, 0.003% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Blurred vision:moderate/severe, duration >=5 min | 4.2 percentage of participants |
| CP-690,550, 0.003% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Ocular discomfort:none | 52.1 percentage of participants |
| CP-690,550, 0.003% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Ocular discomfort:mild | 29.2 percentage of participants |
| CP-690,550, 0.003% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Ocular discomfort:moderate | 14.6 percentage of participants |
| CP-690,550, 0.003% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Tearing:severe | 0.0 percentage of participants |
| CP-690,550, 0.003% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Ocular discomfort:severe | 4.2 percentage of participants |
| CP-690,550, 0.003% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Pain:moderate/severe, duration >=5 min | 0.0 percentage of participants |
| CP-690,550, 0.003% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Ocular discomfort:moderate/severe, duration>=5 min | 10.4 percentage of participants |
| CP-690,550, 0.003% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Burning sensation:none | 33.3 percentage of participants |
| CP-690,550, 0.003% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Tearing:mild | 16.7 percentage of participants |
| CP-690,550, 0.003% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Burning sensation:mild | 39.6 percentage of participants |
| CP-690,550, 0.003% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Tearing:moderate/severe, duration >= 5 min | 2.1 percentage of participants |
| CP-690,550, 0.003% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Burning sensation:severe | 4.2 percentage of participants |
| CP-690,550, 0.003% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Pain:severe | 2.1 percentage of participants |
| CP-690,550, 0.003% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Burning sensation:moderate/severe,duration>=5 min | 0.0 percentage of participants |
| CP-690,550, 0.005% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Ocular discomfort:moderate | 8.5 percentage of participants |
| CP-690,550, 0.005% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Ocular discomfort:mild | 44.7 percentage of participants |
| CP-690,550, 0.005% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Pain:mild | 12.8 percentage of participants |
| CP-690,550, 0.005% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Burning sensation:mild | 53.2 percentage of participants |
| CP-690,550, 0.005% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Ocular discomfort:none | 46.8 percentage of participants |
| CP-690,550, 0.005% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Blurred vision:moderate/severe, duration >=5 min | 6.4 percentage of participants |
| CP-690,550, 0.005% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Tearing:mild | 29.8 percentage of participants |
| CP-690,550, 0.005% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Blurred vision:severe | 4.3 percentage of participants |
| CP-690,550, 0.005% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Tearing:none | 66.0 percentage of participants |
| CP-690,550, 0.005% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Tearing:moderate/severe, duration >= 5 min | 0.0 percentage of participants |
| CP-690,550, 0.005% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Burning sensation:moderate | 14.9 percentage of participants |
| CP-690,550, 0.005% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Blurred vision:moderate | 8.5 percentage of participants |
| CP-690,550, 0.005% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Pain:severe | 0.0 percentage of participants |
| CP-690,550, 0.005% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Tearing:moderate | 4.3 percentage of participants |
| CP-690,550, 0.005% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Blurred vision:mild | 36.2 percentage of participants |
| CP-690,550, 0.005% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Blurred vision:none | 51.1 percentage of participants |
| CP-690,550, 0.005% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Pain:none | 85.1 percentage of participants |
| CP-690,550, 0.005% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Burning sensation:severe | 2.1 percentage of participants |
| CP-690,550, 0.005% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Ocular discomfort:moderate/severe, duration>=5 min | 4.3 percentage of participants |
| CP-690,550, 0.005% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Tearing:severe | 0.0 percentage of participants |
| CP-690,550, 0.005% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Pain:moderate | 2.1 percentage of participants |
| CP-690,550, 0.005% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Burning sensation:none | 29.8 percentage of participants |
| CP-690,550, 0.005% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Burning sensation:moderate/severe,duration>=5 min | 4.3 percentage of participants |
| CP-690,550, 0.005% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Ocular discomfort:severe | 0.0 percentage of participants |
| CP-690,550, 0.005% Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Pain:moderate/severe, duration >=5 min | 0.0 percentage of participants |
| CP-690,550, 0.005% Once Daily | Percentage of Participants With Ocular Tolerability Assessment | Tearing:mild | 11.6 percentage of participants |
| CP-690,550, 0.005% Once Daily | Percentage of Participants With Ocular Tolerability Assessment | Tearing:moderate | 18.6 percentage of participants |
| CP-690,550, 0.005% Once Daily | Percentage of Participants With Ocular Tolerability Assessment | Tearing:severe | 0.0 percentage of participants |
| CP-690,550, 0.005% Once Daily | Percentage of Participants With Ocular Tolerability Assessment | Tearing:moderate/severe, duration >= 5 min | 4.7 percentage of participants |
| CP-690,550, 0.005% Once Daily | Percentage of Participants With Ocular Tolerability Assessment | Blurred vision:none | 44.2 percentage of participants |
| CP-690,550, 0.005% Once Daily | Percentage of Participants With Ocular Tolerability Assessment | Blurred vision:mild | 34.9 percentage of participants |
| CP-690,550, 0.005% Once Daily | Percentage of Participants With Ocular Tolerability Assessment | Blurred vision:moderate | 18.6 percentage of participants |
| CP-690,550, 0.005% Once Daily | Percentage of Participants With Ocular Tolerability Assessment | Blurred vision:severe | 2.3 percentage of participants |
| CP-690,550, 0.005% Once Daily | Percentage of Participants With Ocular Tolerability Assessment | Blurred vision:moderate/severe, duration >=5 min | 7.0 percentage of participants |
| CP-690,550, 0.005% Once Daily | Percentage of Participants With Ocular Tolerability Assessment | Ocular discomfort:none | 69.8 percentage of participants |
| CP-690,550, 0.005% Once Daily | Percentage of Participants With Ocular Tolerability Assessment | Ocular discomfort:mild | 18.6 percentage of participants |
| CP-690,550, 0.005% Once Daily | Percentage of Participants With Ocular Tolerability Assessment | Ocular discomfort:moderate | 9.3 percentage of participants |
| CP-690,550, 0.005% Once Daily | Percentage of Participants With Ocular Tolerability Assessment | Ocular discomfort:severe | 2.3 percentage of participants |
| CP-690,550, 0.005% Once Daily | Percentage of Participants With Ocular Tolerability Assessment | Ocular discomfort:moderate/severe, duration>=5 min | 7.0 percentage of participants |
| CP-690,550, 0.005% Once Daily | Percentage of Participants With Ocular Tolerability Assessment | Burning sensation:none | 32.6 percentage of participants |
| CP-690,550, 0.005% Once Daily | Percentage of Participants With Ocular Tolerability Assessment | Burning sensation:mild | 48.8 percentage of participants |
| CP-690,550, 0.005% Once Daily | Percentage of Participants With Ocular Tolerability Assessment | Burning sensation:moderate | 16.3 percentage of participants |
| CP-690,550, 0.005% Once Daily | Percentage of Participants With Ocular Tolerability Assessment | Burning sensation:severe | 2.3 percentage of participants |
| CP-690,550, 0.005% Once Daily | Percentage of Participants With Ocular Tolerability Assessment | Burning sensation:moderate/severe,duration>=5 min | 4.7 percentage of participants |
| CP-690,550, 0.005% Once Daily | Percentage of Participants With Ocular Tolerability Assessment | Pain:none | 88.4 percentage of participants |
| CP-690,550, 0.005% Once Daily | Percentage of Participants With Ocular Tolerability Assessment | Pain:mild | 7.0 percentage of participants |
| CP-690,550, 0.005% Once Daily | Percentage of Participants With Ocular Tolerability Assessment | Pain:moderate | 2.3 percentage of participants |
| CP-690,550, 0.005% Once Daily | Percentage of Participants With Ocular Tolerability Assessment | Pain:severe | 2.3 percentage of participants |
| CP-690,550, 0.005% Once Daily | Percentage of Participants With Ocular Tolerability Assessment | Pain:moderate/severe, duration >=5 min | 0.0 percentage of participants |
| CP-690,550, 0.005% Once Daily | Percentage of Participants With Ocular Tolerability Assessment | Tearing:none | 69.8 percentage of participants |
| Restasis Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Burning sensation:moderate/severe,duration>=5 min | 11.4 percentage of participants |
| Restasis Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Burning sensation:severe | 4.5 percentage of participants |
| Restasis Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Burning sensation:moderate | 36.4 percentage of participants |
| Restasis Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Tearing:severe | 11.4 percentage of participants |
| Restasis Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Pain:severe | 4.5 percentage of participants |
| Restasis Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Burning sensation:mild | 40.9 percentage of participants |
| Restasis Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Burning sensation:none | 18.2 percentage of participants |
| Restasis Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Ocular discomfort:moderate/severe, duration>=5 min | 22.7 percentage of participants |
| Restasis Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Ocular discomfort:severe | 6.8 percentage of participants |
| Restasis Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Ocular discomfort:moderate | 25.0 percentage of participants |
| Restasis Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Tearing:moderate | 11.4 percentage of participants |
| Restasis Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Pain:moderate/severe, duration >=5 min | 0.0 percentage of participants |
| Restasis Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Ocular discomfort:mild | 34.1 percentage of participants |
| Restasis Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Ocular discomfort:none | 34.1 percentage of participants |
| Restasis Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Blurred vision:moderate/severe, duration >=5 min | 2.3 percentage of participants |
| Restasis Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Blurred vision:severe | 2.3 percentage of participants |
| Restasis Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Blurred vision:moderate | 20.5 percentage of participants |
| Restasis Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Tearing:mild | 29.5 percentage of participants |
| Restasis Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Tearing:none | 47.7 percentage of participants |
| Restasis Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Blurred vision:mild | 40.9 percentage of participants |
| Restasis Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Blurred vision:none | 36.4 percentage of participants |
| Restasis Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Tearing:moderate/severe, duration >= 5 min | 6.8 percentage of participants |
| Restasis Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Pain:moderate | 9.1 percentage of participants |
| Restasis Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Pain:mild | 25.0 percentage of participants |
| Restasis Twice Daily | Percentage of Participants With Ocular Tolerability Assessment | Pain:none | 61.4 percentage of participants |
Primary
Percentage of Participants With Systemic Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Systemic AEs are the events which are not localized but occur throughout the systemic circulation.
Time frame: Baseline up to Week 8
Population: Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Twice Daily | Percentage of Participants With Systemic Adverse Events (AEs) | 27.7 percentage of participants |
| CP-690,550, 0.0003% Twice Daily | Percentage of Participants With Systemic Adverse Events (AEs) | 8.7 percentage of participants |
| CP-690,550, 0.001% Twice Daily | Percentage of Participants With Systemic Adverse Events (AEs) | 29.8 percentage of participants |
| CP-690,550, 0.003% Twice Daily | Percentage of Participants With Systemic Adverse Events (AEs) | 27.1 percentage of participants |
| CP-690,550, 0.005% Twice Daily | Percentage of Participants With Systemic Adverse Events (AEs) | 18.8 percentage of participants |
| CP-690,550, 0.005% Once Daily | Percentage of Participants With Systemic Adverse Events (AEs) | 18.2 percentage of participants |
| Restasis Twice Daily | Percentage of Participants With Systemic Adverse Events (AEs) | 23.4 percentage of participants |
Secondary
Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8
Corneal staining was assessed using fluorescein dye, a yellow filter, and a slit lamp. The cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale; where 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. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
Time frame: Baseline, Week 1, 2, 4, 6, 8
Population: ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. Here, 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Twice Daily | Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8 | Change at Week 4 (n=44,43,45,48,44,39,43) | -2.48 units on a scale | Standard Deviation 2.53 |
| Placebo Twice Daily | Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8 | Change at Week 8 (n=45,46,47,48,47,44,45) | -2.67 units on a scale | Standard Deviation 3.44 |
| Placebo Twice Daily | Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8 | Change at Week 1 (n=45,45,47,47,44,42,44) | -1.16 units on a scale | Standard Deviation 2.39 |
| Placebo Twice Daily | Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8 | Baseline (n=47,46,47,48,48,44,47) | 6.64 units on a scale | Standard Deviation 3.45 |
| Placebo Twice Daily | Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8 | Change at Week 6 (n=43,44,43,48,42,41,43) | -2.21 units on a scale | Standard Deviation 3.49 |
| Placebo Twice Daily | Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8 | Change at Week 2 (n=44,46,46,48,45,44,44) | -1.02 units on a scale | Standard Deviation 3.16 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8 | Baseline (n=47,46,47,48,48,44,47) | 5.63 units on a scale | Standard Deviation 1.95 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8 | Change at Week 4 (n=44,43,45,48,44,39,43) | -1.02 units on a scale | Standard Deviation 2.58 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8 | Change at Week 1 (n=45,45,47,47,44,42,44) | -0.89 units on a scale | Standard Deviation 2.05 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8 | Change at Week 8 (n=45,46,47,48,47,44,45) | -1.39 units on a scale | Standard Deviation 2.92 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8 | Change at Week 6 (n=43,44,43,48,42,41,43) | -1.39 units on a scale | Standard Deviation 2.5 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8 | Change at Week 2 (n=44,46,46,48,45,44,44) | -1.15 units on a scale | Standard Deviation 2.33 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8 | Change at Week 6 (n=43,44,43,48,42,41,43) | -1.21 units on a scale | Standard Deviation 2.42 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8 | Change at Week 2 (n=44,46,46,48,45,44,44) | -1.00 units on a scale | Standard Deviation 2.19 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8 | Change at Week 8 (n=45,46,47,48,47,44,45) | -1.28 units on a scale | Standard Deviation 2.65 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8 | Change at Week 4 (n=44,43,45,48,44,39,43) | -1.33 units on a scale | Standard Deviation 2.69 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8 | Baseline (n=47,46,47,48,48,44,47) | 5.83 units on a scale | Standard Deviation 2.1 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8 | Change at Week 1 (n=45,45,47,47,44,42,44) | -0.87 units on a scale | Standard Deviation 2.25 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8 | Change at Week 6 (n=43,44,43,48,42,41,43) | -1.75 units on a scale | Standard Deviation 3.06 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8 | Baseline (n=47,46,47,48,48,44,47) | 6.73 units on a scale | Standard Deviation 2.94 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8 | Change at Week 1 (n=45,45,47,47,44,42,44) | -1.32 units on a scale | Standard Deviation 2.58 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8 | Change at Week 2 (n=44,46,46,48,45,44,44) | -1.98 units on a scale | Standard Deviation 2.5 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8 | Change at Week 4 (n=44,43,45,48,44,39,43) | -1.40 units on a scale | Standard Deviation 2.54 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8 | Change at Week 8 (n=45,46,47,48,47,44,45) | -1.58 units on a scale | Standard Deviation 3.04 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8 | Change at Week 4 (n=44,43,45,48,44,39,43) | -0.82 units on a scale | Standard Deviation 2.45 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8 | Change at Week 1 (n=45,45,47,47,44,42,44) | -0.20 units on a scale | Standard Deviation 1.95 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8 | Change at Week 6 (n=43,44,43,48,42,41,43) | -1.31 units on a scale | Standard Deviation 3 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8 | Change at Week 8 (n=45,46,47,48,47,44,45) | -1.47 units on a scale | Standard Deviation 2.73 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8 | Change at Week 2 (n=44,46,46,48,45,44,44) | -0.91 units on a scale | Standard Deviation 2.26 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8 | Baseline (n=47,46,47,48,48,44,47) | 6.21 units on a scale | Standard Deviation 2.54 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8 | Change at Week 2 (n=44,46,46,48,45,44,44) | -1.52 units on a scale | Standard Deviation 2.73 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8 | Change at Week 4 (n=44,43,45,48,44,39,43) | -2.10 units on a scale | Standard Deviation 2.31 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8 | Change at Week 1 (n=45,45,47,47,44,42,44) | -1.17 units on a scale | Standard Deviation 2.51 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8 | Change at Week 6 (n=43,44,43,48,42,41,43) | -2.27 units on a scale | Standard Deviation 2.69 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8 | Baseline (n=47,46,47,48,48,44,47) | 6.36 units on a scale | Standard Deviation 2.71 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8 | Change at Week 8 (n=45,46,47,48,47,44,45) | -2.64 units on a scale | Standard Deviation 2.94 |
| Restasis Twice Daily | Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8 | Change at Week 2 (n=44,46,46,48,45,44,44) | -0.61 units on a scale | Standard Deviation 2.94 |
| Restasis Twice Daily | Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8 | Change at Week 1 (n=45,45,47,47,44,42,44) | 0.02 units on a scale | Standard Deviation 3.27 |
| Restasis Twice Daily | Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8 | Change at Week 8 (n=45,46,47,48,47,44,45) | -1.18 units on a scale | Standard Deviation 3.5 |
| Restasis Twice Daily | Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8 | Change at Week 4 (n=44,43,45,48,44,39,43) | -1.00 units on a scale | Standard Deviation 2.86 |
| Restasis Twice Daily | Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8 | Change at Week 6 (n=43,44,43,48,42,41,43) | -1.49 units on a scale | Standard Deviation 3.03 |
| Restasis Twice Daily | Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8 | Baseline (n=47,46,47,48,48,44,47) | 6.85 units on a scale | Standard Deviation 3.5 |
Secondary
Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8
Daily artificial tear use was assessed by collecting data on daily number of drops of artificial tear instilled in the eye using a participant diary. Decrease in daily artificial tear use indicated improvement.
Time frame: Baseline, Week 1, 2, 4, 6, 8
Population: ITT population. LOCF method was used for imputing missing data at Week 8. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Twice Daily | Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8 | Change at Week 8 (n=46,46,47,48,47,43,46) | -1.2 drops/day | Standard Deviation 1.36 |
| Placebo Twice Daily | Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8 | Change at Week 1 (n=45,46,47,48,47,43,45) | -0.7 drops/day | Standard Deviation 1.27 |
| Placebo Twice Daily | Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8 | Change at Week 4 (n=44,44,45,48,45,41,44) | -1.1 drops/day | Standard Deviation 1.6 |
| Placebo Twice Daily | Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8 | Baseline (n=47,46,47,48,48,43,47) | 3.4 drops/day | Standard Deviation 1.58 |
| Placebo Twice Daily | Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8 | Change at Week 2 (n=44,46,45,48,47,42,44) | -0.9 drops/day | Standard Deviation 1.31 |
| Placebo Twice Daily | Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8 | Change at Week 6 (n=44,44,46,48,43,40,43) | -1.5 drops/day | Standard Deviation 1.51 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8 | Baseline (n=47,46,47,48,48,43,47) | 3.0 drops/day | Standard Deviation 1.63 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8 | Change at Week 4 (n=44,44,45,48,45,41,44) | -1.5 drops/day | Standard Deviation 1.22 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8 | Change at Week 8 (n=46,46,47,48,47,43,46) | -1.6 drops/day | Standard Deviation 1.2 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8 | Change at Week 1 (n=45,46,47,48,47,43,45) | -1.1 drops/day | Standard Deviation 0.99 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8 | Change at Week 6 (n=44,44,46,48,43,40,43) | -1.5 drops/day | Standard Deviation 1.08 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8 | Change at Week 2 (n=44,46,45,48,47,42,44) | -1.2 drops/day | Standard Deviation 1.09 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8 | Change at Week 6 (n=44,44,46,48,43,40,43) | -0.9 drops/day | Standard Deviation 1.15 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8 | Change at Week 2 (n=44,46,45,48,47,42,44) | -0.8 drops/day | Standard Deviation 1.2 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8 | Change at Week 8 (n=46,46,47,48,47,43,46) | -1.0 drops/day | Standard Deviation 1.19 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8 | Change at Week 4 (n=44,44,45,48,45,41,44) | -0.9 drops/day | Standard Deviation 1.08 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8 | Baseline (n=47,46,47,48,48,43,47) | 3.0 drops/day | Standard Deviation 1.16 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8 | Change at Week 1 (n=45,46,47,48,47,43,45) | -0.8 drops/day | Standard Deviation 1.01 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8 | Change at Week 6 (n=44,44,46,48,43,40,43) | -1.1 drops/day | Standard Deviation 1.07 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8 | Baseline (n=47,46,47,48,48,43,47) | 2.5 drops/day | Standard Deviation 1.65 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8 | Change at Week 1 (n=45,46,47,48,47,43,45) | -0.8 drops/day | Standard Deviation 1.01 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8 | Change at Week 2 (n=44,46,45,48,47,42,44) | -0.9 drops/day | Standard Deviation 0.99 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8 | Change at Week 4 (n=44,44,45,48,45,41,44) | -1.0 drops/day | Standard Deviation 0.95 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8 | Change at Week 8 (n=46,46,47,48,47,43,46) | -1.2 drops/day | Standard Deviation 1.04 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8 | Change at Week 4 (n=44,44,45,48,45,41,44) | -0.9 drops/day | Standard Deviation 1.29 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8 | Change at Week 1 (n=45,46,47,48,47,43,45) | -0.9 drops/day | Standard Deviation 1.33 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8 | Change at Week 6 (n=44,44,46,48,43,40,43) | -1.0 drops/day | Standard Deviation 1.6 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8 | Change at Week 8 (n=46,46,47,48,47,43,46) | -1.1 drops/day | Standard Deviation 1.52 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8 | Change at Week 2 (n=44,46,45,48,47,42,44) | -0.9 drops/day | Standard Deviation 1.28 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8 | Baseline (n=47,46,47,48,48,43,47) | 3.0 drops/day | Standard Deviation 1.65 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8 | Change at Week 2 (n=44,46,45,48,47,42,44) | -1.0 drops/day | Standard Deviation 1.03 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8 | Change at Week 4 (n=44,44,45,48,45,41,44) | -1.2 drops/day | Standard Deviation 1.27 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8 | Change at Week 1 (n=45,46,47,48,47,43,45) | -1.1 drops/day | Standard Deviation 1.01 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8 | Change at Week 6 (n=44,44,46,48,43,40,43) | -1.3 drops/day | Standard Deviation 1.1 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8 | Baseline (n=47,46,47,48,48,43,47) | 2.8 drops/day | Standard Deviation 1.2 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8 | Change at Week 8 (n=46,46,47,48,47,43,46) | -1.5 drops/day | Standard Deviation 1.27 |
| Restasis Twice Daily | Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8 | Change at Week 2 (n=44,46,45,48,47,42,44) | -0.6 drops/day | Standard Deviation 1.21 |
| Restasis Twice Daily | Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8 | Change at Week 1 (n=45,46,47,48,47,43,45) | -0.6 drops/day | Standard Deviation 1.17 |
| Restasis Twice Daily | Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8 | Change at Week 8 (n=46,46,47,48,47,43,46) | -0.9 drops/day | Standard Deviation 1.34 |
| Restasis Twice Daily | Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8 | Change at Week 4 (n=44,44,45,48,45,41,44) | -0.8 drops/day | Standard Deviation 1.42 |
| Restasis Twice Daily | Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8 | Change at Week 6 (n=44,44,46,48,43,40,43) | -0.7 drops/day | Standard Deviation 1.33 |
| Restasis Twice Daily | Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8 | Baseline (n=47,46,47,48,48,43,47) | 2.9 drops/day | Standard Deviation 1.6 |
Secondary
Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8
Interpalpebral conjunctival staining was performed 1 minute following ocular administration of lissamine green dye with aid of slit lamp. Based on Oxford grading system, bulbar conjunctiva was divided into 2 zones: nasal, temporal. Staining were graded using a 6-point scale (0=absent, 5=severe). Total score=sum of 2 zone scores. Total score range: 0 to 10, higher score=higher damage to eyes due to dryness. Negative change from baseline indicated improvement. Results from study eye are reported. Study eye is the eye with worse Schirmer test score without anesthesia score at baseline.
Time frame: Baseline, Week 1, 2, 4, 6, 8
Population: ITT population. LOCF method was used for imputing missing data at Week 8. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Twice Daily | Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8 | Change at Week 8 (n=45,46,47,48,47,43,45) | -0.82 units on a scale | Standard Deviation 2.01 |
| Placebo Twice Daily | Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8 | Change at Week 1 (n=45,45,47,47,44,42,43) | -0.44 units on a scale | Standard Deviation 1.52 |
| Placebo Twice Daily | Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8 | Change at Week 4 (n=44,43,45,48,44,39,43) | -1.11 units on a scale | Standard Deviation 1.86 |
| Placebo Twice Daily | Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8 | Baseline (n=47,46,47,48,48,43,47) | 2.77 units on a scale | Standard Deviation 2.36 |
| Placebo Twice Daily | Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8 | Change at Week 2 (n=44,46,46,48,45,43,44) | -0.89 units on a scale | Standard Deviation 1.53 |
| Placebo Twice Daily | Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8 | Change at Week 6 (n=43,44,43,48,42,41,43) | -0.84 units on a scale | Standard Deviation 1.38 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8 | Baseline (n=47,46,47,48,48,43,47) | 2.17 units on a scale | Standard Deviation 1.43 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8 | Change at Week 4 (n=44,43,45,48,44,39,43) | -0.53 units on a scale | Standard Deviation 1.65 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8 | Change at Week 8 (n=45,46,47,48,47,43,45) | -0.57 units on a scale | Standard Deviation 1.78 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8 | Change at Week 1 (n=45,45,47,47,44,42,43) | -0.38 units on a scale | Standard Deviation 1.76 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8 | Change at Week 6 (n=43,44,43,48,42,41,43) | -0.73 units on a scale | Standard Deviation 1.63 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8 | Change at Week 2 (n=44,46,46,48,45,43,44) | -0.26 units on a scale | Standard Deviation 1.41 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8 | Change at Week 6 (n=43,44,43,48,42,41,43) | -0.44 units on a scale | Standard Deviation 1.74 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8 | Change at Week 2 (n=44,46,46,48,45,43,44) | -0.37 units on a scale | Standard Deviation 1.44 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8 | Change at Week 8 (n=45,46,47,48,47,43,45) | -0.62 units on a scale | Standard Deviation 1.81 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8 | Change at Week 4 (n=44,43,45,48,44,39,43) | -0.60 units on a scale | Standard Deviation 1.56 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8 | Baseline (n=47,46,47,48,48,43,47) | 2.21 units on a scale | Standard Deviation 1.81 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8 | Change at Week 1 (n=45,45,47,47,44,42,43) | -0.34 units on a scale | Standard Deviation 1.75 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8 | Change at Week 6 (n=43,44,43,48,42,41,43) | -0.46 units on a scale | Standard Deviation 1.68 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8 | Baseline (n=47,46,47,48,48,43,47) | 2.38 units on a scale | Standard Deviation 2.08 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8 | Change at Week 1 (n=45,45,47,47,44,42,43) | -0.13 units on a scale | Standard Deviation 2.06 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8 | Change at Week 2 (n=44,46,46,48,45,43,44) | -0.29 units on a scale | Standard Deviation 1.57 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8 | Change at Week 4 (n=44,43,45,48,44,39,43) | -0.27 units on a scale | Standard Deviation 1.87 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8 | Change at Week 8 (n=45,46,47,48,47,43,45) | -0.63 units on a scale | Standard Deviation 1.71 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8 | Change at Week 4 (n=44,43,45,48,44,39,43) | -0.11 units on a scale | Standard Deviation 1.37 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8 | Change at Week 1 (n=45,45,47,47,44,42,43) | -0.45 units on a scale | Standard Deviation 1.42 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8 | Change at Week 6 (n=43,44,43,48,42,41,43) | -0.12 units on a scale | Standard Deviation 1.71 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8 | Change at Week 8 (n=45,46,47,48,47,43,45) | -0.13 units on a scale | Standard Deviation 1.78 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8 | Change at Week 2 (n=44,46,46,48,45,43,44) | -0.44 units on a scale | Standard Deviation 1.62 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8 | Baseline (n=47,46,47,48,48,43,47) | 2.17 units on a scale | Standard Deviation 1.99 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8 | Change at Week 2 (n=44,46,46,48,45,43,44) | -0.19 units on a scale | Standard Deviation 1.38 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8 | Change at Week 4 (n=44,43,45,48,44,39,43) | 0.18 units on a scale | Standard Deviation 1.35 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8 | Change at Week 1 (n=45,45,47,47,44,42,43) | 0.17 units on a scale | Standard Deviation 1.5 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8 | Change at Week 6 (n=43,44,43,48,42,41,43) | 0.02 units on a scale | Standard Deviation 1.98 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8 | Baseline (n=47,46,47,48,48,43,47) | 1.91 units on a scale | Standard Deviation 1.66 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8 | Change at Week 8 (n=45,46,47,48,47,43,45) | -0.14 units on a scale | Standard Deviation 1.82 |
| Restasis Twice Daily | Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8 | Change at Week 2 (n=44,46,46,48,45,43,44) | 0.05 units on a scale | Standard Deviation 2.47 |
| Restasis Twice Daily | Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8 | Change at Week 1 (n=45,45,47,47,44,42,43) | -0.09 units on a scale | Standard Deviation 1.92 |
| Restasis Twice Daily | Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8 | Change at Week 8 (n=45,46,47,48,47,43,45) | -0.18 units on a scale | Standard Deviation 1.57 |
| Restasis Twice Daily | Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8 | Change at Week 4 (n=44,43,45,48,44,39,43) | -0.07 units on a scale | Standard Deviation 1.64 |
| Restasis Twice Daily | Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8 | Change at Week 6 (n=43,44,43,48,42,41,43) | -0.14 units on a scale | Standard Deviation 1.9 |
| Restasis Twice Daily | Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8 | Baseline (n=47,46,47,48,48,43,47) | 2.43 units on a scale | Standard Deviation 2.03 |
Secondary
Change From Baseline in Modified Ocular Comfort Index (mOCI) Raw Scores at Week 1, 2, 4, 6 and 8
mOCI consisted of the original 12-item OCI plus additional questions on other dry eye symptoms and their impact to participant's life. Each item was measured on a 7-point Likert scale ranging from 0 (never) to 6 (always/severe). Negative change from baseline indicated improvement.
Time frame: Baseline, Week 1, 2, 4, 6, 8
Population: Data for mOCI raw score was not analyzed due to the exploratory nature and overwhelming amount of data derived from the analysis.
Secondary
Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8
NEI-VFQ-25 questionnaire included 25 items based on which overall composite VFQ score and 12 subscales were derived: general health (GH), general vision (GV), ocular pain (OP), near activities (NAct), distance activities (DA), social functioning (SF), mental health (MH), role difficulties (RD), dependency, driving, color vision (CV) and peripheral vision (PV). Response to each question converted to 0-100 score. Each subscale, total score=average of items contributing to score. For each subscale and total score, score range: 0 to 100, higher score=less symptoms/better visual functioning.
Time frame: Baseline, Week 8
Population: ITT population included all enrolled participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: RD (n=43,43,44,48,41,40,41) | 6.98 Units on a scale | Standard Deviation 15.74 |
| Placebo Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: MH (n=47,46,47,48,48,43,47) | 72.34 Units on a scale | Standard Deviation 24.55 |
| Placebo Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: NAct (n=47,46,47,48,48,43,47) | 68.62 Units on a scale | Standard Deviation 18.49 |
| Placebo Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: SF (n=47,46,47,48,48,43,47) | 89.10 Units on a scale | Standard Deviation 14.89 |
| Placebo Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: DA (n=47,46,47,48,48,43,47) | 73.76 Units on a scale | Standard Deviation 17.63 |
| Placebo Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: OP (n=43,43,44,48,41,40,41) | 15.12 Units on a scale | Standard Deviation 19.59 |
| Placebo Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: DA (n=43,43,44,48,41,40,41) | 6.78 Units on a scale | Standard Deviation 12.5 |
| Placebo Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: GV (n=43,43,44,48,41,40,41) | 1.86 Units on a scale | Standard Deviation 16.22 |
| Placebo Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change Week 8:dependency(n=43,42,44,47,41,40,41) | 7.56 Units on a scale | Standard Deviation 21.32 |
| Placebo Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: SF (n=43,43,44,48,41,40,41) | 3.20 Units on a scale | Standard Deviation 12.82 |
| Placebo Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: GH (n=42,43,44,48,41,40,41) | 0.00 Units on a scale | Standard Deviation 13.53 |
| Placebo Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8:driving (n=42,41,42,46,33,38,39) | 6.15 Units on a scale | Standard Deviation 14.47 |
| Placebo Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: Overall (n=47,46,47,48,48,43,47) | 75.62 Units on a scale | Standard Deviation 14.43 |
| Placebo Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: CV (n=42,43,44,48,41,40,41) | 4.76 Units on a scale | Standard Deviation 13.79 |
| Placebo Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: PV (n=47,46,46,48,46,43,47) | 77.13 Units on a scale | Standard Deviation 23.21 |
| Placebo Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: PV (n=43,43,44,48,39,40,41) | 11.05 Units on a scale | Standard Deviation 22.03 |
| Placebo Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: CV (n=46,46,47,48,48,43,47) | 89.67 Units on a scale | Standard Deviation 21.46 |
| Placebo Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: Overall (n=43,43,44,48,41,40,41) | 7.44 Units on a scale | Standard Deviation 9.55 |
| Placebo Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline:driving (n=46,44,45,46,41,41,44) | 73.64 Units on a scale | Standard Deviation 17.15 |
| Placebo Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: GH (n=46,46,47,48,48,43,47) | 65.22 Units on a scale | Standard Deviation 20.74 |
| Placebo Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline:dependency (n=47,45,47,47,48,43,47) | 88.48 Units on a scale | Standard Deviation 21.46 |
| Placebo Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: GV (n=47,46,47,48,48,43,47) | 72.77 Units on a scale | Standard Deviation 16.38 |
| Placebo Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: NAct (n=43,43,44,48,41,40,41) | 7.17 Units on a scale | Standard Deviation 17.21 |
| Placebo Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: RD (n=47,46,47,48,48,43,47) | 68.09 Units on a scale | Standard Deviation 23.28 |
| Placebo Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: OP (n=47,46,47,48,48,43,47) | 59.31 Units on a scale | Standard Deviation 18.7 |
| Placebo Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: MH (n=43,43,44,48,41,40,41) | 10.61 Units on a scale | Standard Deviation 19.27 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change Week 8:dependency(n=43,42,44,47,41,40,41) | 1.19 Units on a scale | Standard Deviation 15.79 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: GH (n=46,46,47,48,48,43,47) | 66.85 Units on a scale | Standard Deviation 21.12 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: GH (n=42,43,44,48,41,40,41) | -2.91 Units on a scale | Standard Deviation 14.65 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: NAct (n=43,43,44,48,41,40,41) | 8.62 Units on a scale | Standard Deviation 15.33 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8:driving (n=42,41,42,46,33,38,39) | 3.46 Units on a scale | Standard Deviation 16.24 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: SF (n=43,43,44,48,41,40,41) | 2.62 Units on a scale | Standard Deviation 11.75 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: Overall (n=47,46,47,48,48,43,47) | 79.30 Units on a scale | Standard Deviation 10.95 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline:dependency (n=47,45,47,47,48,43,47) | 93.89 Units on a scale | Standard Deviation 10.42 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: CV (n=42,43,44,48,41,40,41) | 2.33 Units on a scale | Standard Deviation 9.15 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: PV (n=47,46,46,48,46,43,47) | 82.61 Units on a scale | Standard Deviation 20.32 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: RD (n=47,46,47,48,48,43,47) | 72.83 Units on a scale | Standard Deviation 20.12 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: OP (n=47,46,47,48,48,43,47) | 59.51 Units on a scale | Standard Deviation 18.85 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: PV (n=43,43,44,48,39,40,41) | 4.07 Units on a scale | Standard Deviation 15.36 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: CV (n=46,46,47,48,48,43,47) | 96.20 Units on a scale | Standard Deviation 9.08 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: GV (n=47,46,47,48,48,43,47) | 75.65 Units on a scale | Standard Deviation 12.59 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: MH (n=47,46,47,48,48,43,47) | 73.23 Units on a scale | Standard Deviation 19.88 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: Overall (n=43,43,44,48,41,40,41) | 5.13 Units on a scale | Standard Deviation 9.2 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: NAct (n=47,46,47,48,48,43,47) | 70.92 Units on a scale | Standard Deviation 17.53 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: MH (n=43,43,44,48,41,40,41) | 9.59 Units on a scale | Standard Deviation 17.27 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: SF (n=47,46,47,48,48,43,47) | 93.21 Units on a scale | Standard Deviation 10.77 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: DA (n=47,46,47,48,48,43,47) | 77.36 Units on a scale | Standard Deviation 17.71 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: DA (n=43,43,44,48,41,40,41) | 5.43 Units on a scale | Standard Deviation 13.22 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: OP (n=43,43,44,48,41,40,41) | 11.63 Units on a scale | Standard Deviation 21.89 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: RD (n=43,43,44,48,41,40,41) | 5.52 Units on a scale | Standard Deviation 27.59 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline:driving (n=46,44,45,46,41,41,44) | 76.89 Units on a scale | Standard Deviation 15.65 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: GV (n=43,43,44,48,41,40,41) | 1.86 Units on a scale | Standard Deviation 12.2 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: OP (n=47,46,47,48,48,43,47) | 61.17 Units on a scale | Standard Deviation 20.89 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change Week 8:dependency(n=43,42,44,47,41,40,41) | 1.89 Units on a scale | Standard Deviation 8.96 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: OP (n=43,43,44,48,41,40,41) | 13.35 Units on a scale | Standard Deviation 20.95 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: GH (n=42,43,44,48,41,40,41) | 0.00 Units on a scale | Standard Deviation 15.25 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: GV (n=47,46,47,48,48,43,47) | 73.62 Units on a scale | Standard Deviation 14.51 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: GH (n=46,46,47,48,48,43,47) | 62.77 Units on a scale | Standard Deviation 20.1 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: GV (n=43,43,44,48,41,40,41) | 1.36 Units on a scale | Standard Deviation 7.95 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline:driving (n=46,44,45,46,41,41,44) | 77.22 Units on a scale | Standard Deviation 19.09 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8:driving (n=42,41,42,46,33,38,39) | 3.27 Units on a scale | Standard Deviation 13.64 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: NAct (n=47,46,47,48,48,43,47) | 76.60 Units on a scale | Standard Deviation 18.6 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: Overall (n=47,46,47,48,48,43,47) | 81.08 Units on a scale | Standard Deviation 12.99 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: MH (n=47,46,47,48,48,43,47) | 77.53 Units on a scale | Standard Deviation 19.71 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline:dependency (n=47,45,47,47,48,43,47) | 94.33 Units on a scale | Standard Deviation 11.54 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: SF (n=47,46,47,48,48,43,47) | 93.88 Units on a scale | Standard Deviation 11.62 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: RD (n=47,46,47,48,48,43,47) | 76.33 Units on a scale | Standard Deviation 25.96 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: CV (n=42,43,44,48,41,40,41) | 3.98 Units on a scale | Standard Deviation 10.71 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: SF (n=43,43,44,48,41,40,41) | 2.27 Units on a scale | Standard Deviation 10.54 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: PV (n=47,46,46,48,46,43,47) | 85.87 Units on a scale | Standard Deviation 21.51 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: Overall (n=43,43,44,48,41,40,41) | 3.98 Units on a scale | Standard Deviation 7.44 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: NAct (n=43,43,44,48,41,40,41) | 4.17 Units on a scale | Standard Deviation 12.64 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: RD (n=43,43,44,48,41,40,41) | 4.55 Units on a scale | Standard Deviation 20.37 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: DA (n=47,46,47,48,48,43,47) | 81.38 Units on a scale | Standard Deviation 16.32 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: PV (n=43,43,44,48,39,40,41) | 1.70 Units on a scale | Standard Deviation 15.62 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: DA (n=43,43,44,48,41,40,41) | 3.03 Units on a scale | Standard Deviation 13.46 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: CV (n=46,46,47,48,48,43,47) | 93.62 Units on a scale | Standard Deviation 13.26 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: MH (n=43,43,44,48,41,40,41) | 4.55 Units on a scale | Standard Deviation 13.57 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: DA (n=47,46,47,48,48,43,47) | 72.05 Units on a scale | Standard Deviation 25.12 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: SF (n=43,43,44,48,41,40,41) | 3.39 Units on a scale | Standard Deviation 13.58 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: MH (n=43,43,44,48,41,40,41) | 5.34 Units on a scale | Standard Deviation 15.95 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: RD (n=43,43,44,48,41,40,41) | 5.47 Units on a scale | Standard Deviation 18.93 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change Week 8:dependency(n=43,42,44,47,41,40,41) | 4.61 Units on a scale | Standard Deviation 14.83 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8:driving (n=42,41,42,46,33,38,39) | 0.36 Units on a scale | Standard Deviation 12.29 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: CV (n=42,43,44,48,41,40,41) | 2.08 Units on a scale | Standard Deviation 16.97 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: PV (n=43,43,44,48,39,40,41) | 3.65 Units on a scale | Standard Deviation 18.59 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: Overall (n=43,43,44,48,41,40,41) | 4.50 Units on a scale | Standard Deviation 8.19 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: GH (n=46,46,47,48,48,43,47) | 66.15 Units on a scale | Standard Deviation 24.99 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: GV (n=47,46,47,48,48,43,47) | 72.50 Units on a scale | Standard Deviation 20.05 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: OP (n=47,46,47,48,48,43,47) | 53.65 Units on a scale | Standard Deviation 23.06 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: NAct (n=47,46,47,48,48,43,47) | 64.41 Units on a scale | Standard Deviation 23.36 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: DA (n=43,43,44,48,41,40,41) | 4.43 Units on a scale | Standard Deviation 11.32 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: SF (n=47,46,47,48,48,43,47) | 86.46 Units on a scale | Standard Deviation 21.39 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: MH (n=47,46,47,48,48,43,47) | 64.84 Units on a scale | Standard Deviation 26.13 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: RD (n=47,46,47,48,48,43,47) | 61.98 Units on a scale | Standard Deviation 29.73 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline:dependency (n=47,45,47,47,48,43,47) | 81.91 Units on a scale | Standard Deviation 25.79 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline:driving (n=46,44,45,46,41,41,44) | 78.44 Units on a scale | Standard Deviation 20.38 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: CV (n=46,46,47,48,48,43,47) | 90.10 Units on a scale | Standard Deviation 18.41 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: PV (n=47,46,46,48,46,43,47) | 80.21 Units on a scale | Standard Deviation 25.24 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: Overall (n=47,46,47,48,48,43,47) | 73.19 Units on a scale | Standard Deviation 19.31 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: GH (n=42,43,44,48,41,40,41) | 2.08 Units on a scale | Standard Deviation 19.18 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: GV (n=43,43,44,48,41,40,41) | 3.75 Units on a scale | Standard Deviation 12.82 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: OP (n=43,43,44,48,41,40,41) | 9.38 Units on a scale | Standard Deviation 15.79 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: NAct (n=43,43,44,48,41,40,41) | 7.12 Units on a scale | Standard Deviation 16.49 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change Week 8:dependency(n=43,42,44,47,41,40,41) | 5.39 Units on a scale | Standard Deviation 19.59 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: RD (n=47,46,47,48,48,43,47) | 67.71 Units on a scale | Standard Deviation 26.02 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: PV (n=43,43,44,48,39,40,41) | 6.41 Units on a scale | Standard Deviation 21.24 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: DA (n=43,43,44,48,41,40,41) | 8.84 Units on a scale | Standard Deviation 17.88 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: CV (n=46,46,47,48,48,43,47) | 93.75 Units on a scale | Standard Deviation 14.12 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: SF (n=47,46,47,48,48,43,47) | 89.84 Units on a scale | Standard Deviation 14.51 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: Overall (n=47,46,47,48,48,43,47) | 75.06 Units on a scale | Standard Deviation 13.96 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8:driving (n=42,41,42,46,33,38,39) | 3.91 Units on a scale | Standard Deviation 14.43 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: MH (n=43,43,44,48,41,40,41) | 11.28 Units on a scale | Standard Deviation 18.92 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: CV (n=42,43,44,48,41,40,41) | 2.44 Units on a scale | Standard Deviation 13.47 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: NAct (n=43,43,44,48,41,40,41) | 10.87 Units on a scale | Standard Deviation 19.07 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: PV (n=47,46,46,48,46,43,47) | 79.89 Units on a scale | Standard Deviation 21.49 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: OP (n=47,46,47,48,48,43,47) | 55.47 Units on a scale | Standard Deviation 19.28 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: NAct (n=47,46,47,48,48,43,47) | 66.06 Units on a scale | Standard Deviation 20.01 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: GH (n=46,46,47,48,48,43,47) | 59.90 Units on a scale | Standard Deviation 23.49 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: DA (n=47,46,47,48,48,43,47) | 73.00 Units on a scale | Standard Deviation 17.13 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline:dependency (n=47,45,47,47,48,43,47) | 88.02 Units on a scale | Standard Deviation 23.34 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: MH (n=47,46,47,48,48,43,47) | 67.97 Units on a scale | Standard Deviation 22.94 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: GV (n=43,43,44,48,41,40,41) | 1.46 Units on a scale | Standard Deviation 18.11 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: RD (n=43,43,44,48,41,40,41) | 8.23 Units on a scale | Standard Deviation 24.94 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: GV (n=47,46,47,48,48,43,47) | 72.08 Units on a scale | Standard Deviation 13.52 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: Overall (n=43,43,44,48,41,40,41) | 7.15 Units on a scale | Standard Deviation 11.6 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: SF (n=43,43,44,48,41,40,41) | 5.79 Units on a scale | Standard Deviation 13.43 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline:driving (n=46,44,45,46,41,41,44) | 71.54 Units on a scale | Standard Deviation 22.28 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: OP (n=43,43,44,48,41,40,41) | 11.59 Units on a scale | Standard Deviation 19.24 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: GH (n=42,43,44,48,41,40,41) | 1.22 Units on a scale | Standard Deviation 18.5 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: GV (n=43,43,44,48,41,40,41) | 5.00 Units on a scale | Standard Deviation 15.53 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: MH (n=47,46,47,48,48,43,47) | 72.67 Units on a scale | Standard Deviation 22.24 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: GV (n=47,46,47,48,48,43,47) | 70.70 Units on a scale | Standard Deviation 17.1 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: RD (n=47,46,47,48,48,43,47) | 68.02 Units on a scale | Standard Deviation 26.91 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: GH (n=46,46,47,48,48,43,47) | 66.86 Units on a scale | Standard Deviation 25.43 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: SF (n=43,43,44,48,41,40,41) | 6.88 Units on a scale | Standard Deviation 18.55 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline:dependency (n=47,45,47,47,48,43,47) | 87.79 Units on a scale | Standard Deviation 22.15 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: Overall (n=43,43,44,48,41,40,41) | 8.67 Units on a scale | Standard Deviation 11.5 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline:driving (n=46,44,45,46,41,41,44) | 71.65 Units on a scale | Standard Deviation 21.23 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: PV (n=43,43,44,48,39,40,41) | 6.88 Units on a scale | Standard Deviation 20.4 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: CV (n=46,46,47,48,48,43,47) | 91.28 Units on a scale | Standard Deviation 17.15 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: CV (n=42,43,44,48,41,40,41) | 5.63 Units on a scale | Standard Deviation 19.19 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: PV (n=47,46,46,48,46,43,47) | 79.65 Units on a scale | Standard Deviation 26.31 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8:driving (n=42,41,42,46,33,38,39) | 8.22 Units on a scale | Standard Deviation 13.65 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: NAct (n=43,43,44,48,41,40,41) | 7.40 Units on a scale | Standard Deviation 15.49 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: Overall (n=47,46,47,48,48,43,47) | 75.40 Units on a scale | Standard Deviation 15.58 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change Week 8:dependency(n=43,42,44,47,41,40,41) | 7.08 Units on a scale | Standard Deviation 17.45 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: GH (n=42,43,44,48,41,40,41) | -0.63 Units on a scale | Standard Deviation 14.42 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: RD (n=43,43,44,48,41,40,41) | 12.50 Units on a scale | Standard Deviation 25.94 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: MH (n=43,43,44,48,41,40,41) | 10.63 Units on a scale | Standard Deviation 22.3 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: DA (n=43,43,44,48,41,40,41) | 8.85 Units on a scale | Standard Deviation 17.66 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: DA (n=47,46,47,48,48,43,47) | 71.90 Units on a scale | Standard Deviation 20.66 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: NAct (n=47,46,47,48,48,43,47) | 72.00 Units on a scale | Standard Deviation 21.53 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: OP (n=43,43,44,48,41,40,41) | 16.56 Units on a scale | Standard Deviation 20.88 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: SF (n=47,46,47,48,48,43,47) | 87.79 Units on a scale | Standard Deviation 18.99 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: OP (n=47,46,47,48,48,43,47) | 56.40 Units on a scale | Standard Deviation 17.76 |
| Restasis Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: NAct (n=47,46,47,48,48,43,47) | 64.36 Units on a scale | Standard Deviation 23.36 |
| Restasis Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: GH (n=42,43,44,48,41,40,41) | 1.83 Units on a scale | Standard Deviation 10.29 |
| Restasis Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: RD (n=43,43,44,48,41,40,41) | 0.00 Units on a scale | Standard Deviation 29.05 |
| Restasis Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: OP (n=47,46,47,48,48,43,47) | 50.27 Units on a scale | Standard Deviation 24.76 |
| Restasis Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: Overall (n=43,43,44,48,41,40,41) | 5.15 Units on a scale | Standard Deviation 10.42 |
| Restasis Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: DA (n=43,43,44,48,41,40,41) | 5.89 Units on a scale | Standard Deviation 14.67 |
| Restasis Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline:dependency (n=47,45,47,47,48,43,47) | 89.72 Units on a scale | Standard Deviation 19.9 |
| Restasis Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: GH (n=46,46,47,48,48,43,47) | 57.98 Units on a scale | Standard Deviation 20.92 |
| Restasis Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: GV (n=43,43,44,48,41,40,41) | -0.49 Units on a scale | Standard Deviation 10.48 |
| Restasis Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: MH (n=43,43,44,48,41,40,41) | 5.95 Units on a scale | Standard Deviation 16.41 |
| Restasis Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: MH (n=47,46,47,48,48,43,47) | 70.35 Units on a scale | Standard Deviation 23.73 |
| Restasis Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: RD (n=47,46,47,48,48,43,47) | 68.09 Units on a scale | Standard Deviation 27.81 |
| Restasis Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: SF (n=47,46,47,48,48,43,47) | 85.64 Units on a scale | Standard Deviation 20.52 |
| Restasis Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: PV (n=47,46,46,48,46,43,47) | 80.32 Units on a scale | Standard Deviation 22.68 |
| Restasis Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8:driving (n=42,41,42,46,33,38,39) | 3.95 Units on a scale | Standard Deviation 13.07 |
| Restasis Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: SF (n=43,43,44,48,41,40,41) | 8.23 Units on a scale | Standard Deviation 12.06 |
| Restasis Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: CV (n=42,43,44,48,41,40,41) | 4.88 Units on a scale | Standard Deviation 16.03 |
| Restasis Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: GV (n=47,46,47,48,48,43,47) | 73.19 Units on a scale | Standard Deviation 13.37 |
| Restasis Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: CV (n=46,46,47,48,48,43,47) | 90.43 Units on a scale | Standard Deviation 17.72 |
| Restasis Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: OP (n=43,43,44,48,41,40,41) | 9.45 Units on a scale | Standard Deviation 19.72 |
| Restasis Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: Overall (n=47,46,47,48,48,43,47) | 73.97 Units on a scale | Standard Deviation 16.76 |
| Restasis Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change Week 8:dependency(n=43,42,44,47,41,40,41) | 2.24 Units on a scale | Standard Deviation 11.94 |
| Restasis Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline: DA (n=47,46,47,48,48,43,47) | 69.33 Units on a scale | Standard Deviation 21.92 |
| Restasis Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: PV (n=43,43,44,48,39,40,41) | 6.71 Units on a scale | Standard Deviation 20.17 |
| Restasis Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Change at Week 8: NAct (n=43,43,44,48,41,40,41) | 9.96 Units on a scale | Standard Deviation 19.65 |
| Restasis Twice Daily | Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8 | Baseline:driving (n=46,44,45,46,41,41,44) | 71.12 Units on a scale | Standard Deviation 19.8 |
Secondary
Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8
OCI: validated questionnaire 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 Likert scale ranging from 0 (never) to 6 (always/severe). Total score was transformed to range of 0 to 100, higher score indicated more ocular discomfort. Negative change from baseline indicated improvement.
Time frame: Baseline, Week 1, 2, 4, 6, 8
Population: ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. Here, 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Twice Daily | Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8 | Change at Week 8 (n=45,46,47,48,47,44,44) | -9.6 units on a scale | Standard Deviation 8.98 |
| Placebo Twice Daily | Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8 | Change at Week 1 (n=45,45,47,47,44,41,43) | -3.7 units on a scale | Standard Deviation 7.28 |
| Placebo Twice Daily | Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8 | Change at Week 4 (n=44,43,45,48,44,41,43) | -8.9 units on a scale | Standard Deviation 8.44 |
| Placebo Twice Daily | Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8 | Baseline (n=47,46,47,48,48,44,47) | 45.0 units on a scale | Standard Deviation 7.66 |
| Placebo Twice Daily | Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8 | Change at Week 2 (n=44,46,46,48,45,43,44) | -6.3 units on a scale | Standard Deviation 7.89 |
| Placebo Twice Daily | Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8 | Change at Week 6 (n=43,44,43,48,42,41,43) | -10.1 units on a scale | Standard Deviation 9.75 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8 | Baseline (n=47,46,47,48,48,44,47) | 43.9 units on a scale | Standard Deviation 8.09 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8 | Change at Week 4 (n=44,43,45,48,44,41,43) | -7.6 units on a scale | Standard Deviation 9.73 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8 | Change at Week 8 (n=45,46,47,48,47,44,44) | -9.9 units on a scale | Standard Deviation 9.47 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8 | Change at Week 1 (n=45,45,47,47,44,41,43) | -5.9 units on a scale | Standard Deviation 6.44 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8 | Change at Week 6 (n=43,44,43,48,42,41,43) | -9.1 units on a scale | Standard Deviation 9.35 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8 | Change at Week 2 (n=44,46,46,48,45,43,44) | -6.0 units on a scale | Standard Deviation 5.92 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8 | Change at Week 6 (n=43,44,43,48,42,41,43) | -8.8 units on a scale | Standard Deviation 7.46 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8 | Change at Week 2 (n=44,46,46,48,45,43,44) | -6.2 units on a scale | Standard Deviation 9 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8 | Change at Week 8 (n=45,46,47,48,47,44,44) | -8.0 units on a scale | Standard Deviation 8.81 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8 | Change at Week 4 (n=44,43,45,48,44,41,43) | -6.8 units on a scale | Standard Deviation 8.58 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8 | Baseline (n=47,46,47,48,48,44,47) | 44.8 units on a scale | Standard Deviation 7.69 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8 | Change at Week 1 (n=45,45,47,47,44,41,43) | -4.2 units on a scale | Standard Deviation 6.49 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8 | Change at Week 6 (n=43,44,43,48,42,41,43) | -7.5 units on a scale | Standard Deviation 10.31 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8 | Baseline (n=47,46,47,48,48,44,47) | 46.0 units on a scale | Standard Deviation 11.22 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8 | Change at Week 1 (n=45,45,47,47,44,41,43) | -3.9 units on a scale | Standard Deviation 7.68 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8 | Change at Week 2 (n=44,46,46,48,45,43,44) | -5.9 units on a scale | Standard Deviation 7.3 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8 | Change at Week 4 (n=44,43,45,48,44,41,43) | -5.7 units on a scale | Standard Deviation 11.33 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8 | Change at Week 8 (n=45,46,47,48,47,44,44) | -7.4 units on a scale | Standard Deviation 11.34 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8 | Change at Week 4 (n=44,43,45,48,44,41,43) | -8.5 units on a scale | Standard Deviation 10.88 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8 | Change at Week 1 (n=45,45,47,47,44,41,43) | -7.7 units on a scale | Standard Deviation 9.99 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8 | Change at Week 6 (n=43,44,43,48,42,41,43) | -8.0 units on a scale | Standard Deviation 9.72 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8 | Change at Week 8 (n=45,46,47,48,47,44,44) | -8.4 units on a scale | Standard Deviation 9.42 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8 | Change at Week 2 (n=44,46,46,48,45,43,44) | -7.6 units on a scale | Standard Deviation 9.89 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8 | Baseline (n=47,46,47,48,48,44,47) | 45.4 units on a scale | Standard Deviation 8.41 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8 | Change at Week 2 (n=44,46,46,48,45,43,44) | -4.4 units on a scale | Standard Deviation 9.13 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8 | Change at Week 4 (n=44,43,45,48,44,41,43) | -6.1 units on a scale | Standard Deviation 8.33 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8 | Change at Week 1 (n=45,45,47,47,44,41,43) | -4.3 units on a scale | Standard Deviation 7.7 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8 | Change at Week 6 (n=43,44,43,48,42,41,43) | -7.3 units on a scale | Standard Deviation 10.88 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8 | Baseline (n=47,46,47,48,48,44,47) | 42.3 units on a scale | Standard Deviation 7.01 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8 | Change at Week 8 (n=45,46,47,48,47,44,44) | -8.8 units on a scale | Standard Deviation 9.51 |
| Restasis Twice Daily | Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8 | Change at Week 2 (n=44,46,46,48,45,43,44) | -6.8 units on a scale | Standard Deviation 10.59 |
| Restasis Twice Daily | Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8 | Change at Week 1 (n=45,45,47,47,44,41,43) | -3.8 units on a scale | Standard Deviation 7.79 |
| Restasis Twice Daily | Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8 | Change at Week 8 (n=45,46,47,48,47,44,44) | -7.1 units on a scale | Standard Deviation 10.16 |
| Restasis Twice Daily | Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8 | Change at Week 4 (n=44,43,45,48,44,41,43) | -5.2 units on a scale | Standard Deviation 8.23 |
| Restasis Twice Daily | Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8 | Change at Week 6 (n=43,44,43,48,42,41,43) | -7.2 units on a scale | Standard Deviation 9.36 |
| Restasis Twice Daily | Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8 | Baseline (n=47,46,47,48,48,44,47) | 47.4 units on a scale | Standard Deviation 12.51 |
Secondary
Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8
OSDI is a validated instrument for ocular surface disease. It has 12 items, each measured on 5-point Likert scale (0=none of the time, 4=all the time). Based on these item scores, a total OSDI score (question 1 \[Q1\]-Q12) and three subscale scores can be derived: Ocular Symptom (Q1-Q3), Vision-related function (Q4-Q9), and Environmental trigger (Q10-Q12). Each derived score ranges from 0 to 100, with a higher score indicates worse condition.
Time frame: Baseline, Week 1, 2, 4, 6, 8
Population: ITT population. LOCF method was used for imputing missing data at Week 8. Here 'N' (number of participants analyzed) included those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 1:function (n=43,45,44,47,43,39,39) | -6.1 units on a scale | Standard Deviation 15.49 |
| Placebo Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Baseline:symptoms (n=47,46,46,48,48,43,47) | 39.7 units on a scale | Standard Deviation 22.87 |
| Placebo Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Baseline:function (n=46,46,45,48,47,43,44) | 31.8 units on a scale | Standard Deviation 21.05 |
| Placebo Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Baseline:triggers (n=46,41,42,45,42,41,43) | 46.7 units on a scale | Standard Deviation 30.81 |
| Placebo Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 1:total (n=45,45,46,47,44,40,43) | -6.8 units on a scale | Standard Deviation 14.39 |
| Placebo Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 1:symptoms (n=45,45,46,47,44,40,43) | -5.9 units on a scale | Standard Deviation 16.73 |
| Placebo Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Baseline:total (n=47,46,46,48,48,43,47) | 37.6 units on a scale | Standard Deviation 21.46 |
| Placebo Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 1:triggers (n=43,39,39,43,38,35,39) | -7.9 units on a scale | Standard Deviation 23.64 |
| Placebo Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 2:total (n=44,46,45,48,45,43,44) | -8.7 units on a scale | Standard Deviation 12.6 |
| Placebo Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 2:symptoms (n=44,46,45,48,45,43,44) | -9.1 units on a scale | Standard Deviation 18.49 |
| Placebo Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 2:function (n=42,46,42,48,43,43,41) | -8.6 units on a scale | Standard Deviation 14.26 |
| Placebo Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 2:triggers (n=42,40,40,38,35,39,40) | -9.9 units on a scale | Standard Deviation 18.38 |
| Placebo Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 4:total (n=44,43,44,48,44,41,43) | -11.5 units on a scale | Standard Deviation 15.88 |
| Placebo Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 4:symptoms (n=44,43,44,48,44,41,43) | -12.1 units on a scale | Standard Deviation 18.19 |
| Placebo Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 4:function (n=43,42,42,47,41,41,40) | -10.2 units on a scale | Standard Deviation 16.42 |
| Placebo Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 4:triggers (n=43,36,39,43,36,37,39) | -13.5 units on a scale | Standard Deviation 26.02 |
| Placebo Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 6:total (n=43,44,42,48,42,41,43) | -10.5 units on a scale | Standard Deviation 14.26 |
| Placebo Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 6:symptoms (n=43,44,42,48,42,41,43) | -11.2 units on a scale | Standard Deviation 18.36 |
| Placebo Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 6:function (n=42,44,38,46,40,41,40) | -9.1 units on a scale | Standard Deviation 18.88 |
| Placebo Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 6:triggers (n=40,38,37,41,34,38,39) | -13.2 units on a scale | Standard Deviation 21.62 |
| Placebo Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 8:total (n=45,46,46,48,32,35,39) | -11.0 units on a scale | Standard Deviation 18.55 |
| Placebo Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 8:symptoms (n=45,46,46,48,47,43,44) | -13.1 units on a scale | Standard Deviation 20.37 |
| Placebo Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 8:function (n=44,46,45,48,46,43,41) | -9.1 units on a scale | Standard Deviation 21.31 |
| Placebo Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 8:triggers(n=44,41,42,45,,41,41,41) | -12.2 units on a scale | Standard Deviation 24.86 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 1:symptoms (n=45,45,46,47,44,40,43) | -4.1 units on a scale | Standard Deviation 15.85 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Baseline:function (n=46,46,45,48,47,43,44) | 28.8 units on a scale | Standard Deviation 20.3 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 4:symptoms (n=44,43,44,48,44,41,43) | -8.5 units on a scale | Standard Deviation 12.79 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 4:total (n=44,43,44,48,44,41,43) | -7.2 units on a scale | Standard Deviation 12.98 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 8:function (n=44,46,45,48,46,43,41) | -6.4 units on a scale | Standard Deviation 16.54 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 2:triggers (n=42,40,40,38,35,39,40) | -7.9 units on a scale | Standard Deviation 24.98 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Baseline:symptoms (n=47,46,46,48,48,43,47) | 38.8 units on a scale | Standard Deviation 21.6 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Baseline:triggers (n=46,41,42,45,42,41,43) | 49.8 units on a scale | Standard Deviation 29.64 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Baseline:total (n=47,46,46,48,48,43,47) | 35.6 units on a scale | Standard Deviation 19.71 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 1:function (n=43,45,44,47,43,39,39) | -3.7 units on a scale | Standard Deviation 16.32 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 8:symptoms (n=45,46,46,48,47,43,44) | -8.9 units on a scale | Standard Deviation 16.14 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 8:total (n=45,46,46,48,32,35,39) | -8.5 units on a scale | Standard Deviation 15.34 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 6:triggers (n=40,38,37,41,34,38,39) | -13.0 units on a scale | Standard Deviation 24.8 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 1:triggers (n=43,39,39,43,38,35,39) | -12.0 units on a scale | Standard Deviation 24.05 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 1:total (n=45,45,46,47,44,40,43) | -5.1 units on a scale | Standard Deviation 13.61 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 6:function (n=42,44,38,46,40,41,40) | -7.0 units on a scale | Standard Deviation 15.3 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 8:triggers(n=44,41,42,45,,41,41,41) | -14.2 units on a scale | Standard Deviation 24.46 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 2:total (n=44,46,45,48,45,43,44) | -6.2 units on a scale | Standard Deviation 12.09 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 6:symptoms (n=43,44,42,48,42,41,43) | -10.0 units on a scale | Standard Deviation 13.76 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 6:total (n=43,44,42,48,42,41,43) | -9.1 units on a scale | Standard Deviation 14.19 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 2:symptoms (n=44,46,45,48,45,43,44) | -6.2 units on a scale | Standard Deviation 13.99 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 4:triggers (n=43,36,39,43,36,37,39) | -10.4 units on a scale | Standard Deviation 21.9 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 4:function (n=43,42,42,47,41,41,40) | -4.7 units on a scale | Standard Deviation 15.98 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 2:function (n=42,46,42,48,43,43,41) | -5.8 units on a scale | Standard Deviation 13.67 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Baseline:triggers (n=46,41,42,45,42,41,43) | 42.0 units on a scale | Standard Deviation 31.63 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 8:triggers(n=44,41,42,45,,41,41,41) | -8.4 units on a scale | Standard Deviation 23.62 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 6:total (n=43,44,42,48,42,41,43) | -7.9 units on a scale | Standard Deviation 13.89 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 4:total (n=44,43,44,48,44,41,43) | -8.1 units on a scale | Standard Deviation 15.53 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 1:triggers (n=43,39,39,43,38,35,39) | -6.6 units on a scale | Standard Deviation 24.74 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 4:symptoms (n=44,43,44,48,44,41,43) | -13.4 units on a scale | Standard Deviation 20.27 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 6:function (n=42,44,38,46,40,41,40) | -5.1 units on a scale | Standard Deviation 14.46 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 2:triggers (n=42,40,40,38,35,39,40) | -8.8 units on a scale | Standard Deviation 24.76 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Baseline:symptoms (n=47,46,46,48,48,43,47) | 38.6 units on a scale | Standard Deviation 20.66 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 8:function (n=44,46,45,48,46,43,41) | -4.5 units on a scale | Standard Deviation 14.82 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 4:triggers (n=43,36,39,43,36,37,39) | -5.8 units on a scale | Standard Deviation 30.16 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 8:symptoms (n=45,46,46,48,47,43,44) | -11.6 units on a scale | Standard Deviation 20.52 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 2:function (n=42,46,42,48,43,43,41) | -5.5 units on a scale | Standard Deviation 12.92 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 1:symptoms (n=45,45,46,47,44,40,43) | -8.5 units on a scale | Standard Deviation 17.52 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 4:function (n=43,42,42,47,41,41,40) | -6.3 units on a scale | Standard Deviation 16.97 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Baseline:total (n=47,46,46,48,48,43,47) | 31.5 units on a scale | Standard Deviation 17.95 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 6:symptoms (n=43,44,42,48,42,41,43) | -12.3 units on a scale | Standard Deviation 17.96 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 8:total (n=45,46,46,48,32,35,39) | -7.6 units on a scale | Standard Deviation 15.22 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Baseline:function (n=46,46,45,48,47,43,44) | 23.5 units on a scale | Standard Deviation 19.55 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 2:symptoms (n=44,46,45,48,45,43,44) | -11.5 units on a scale | Standard Deviation 17.79 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 1:function (n=43,45,44,47,43,39,39) | -4.4 units on a scale | Standard Deviation 13.48 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 2:total (n=44,46,45,48,45,43,44) | -8.6 units on a scale | Standard Deviation 13.66 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 1:total (n=45,45,46,47,44,40,43) | -6.3 units on a scale | Standard Deviation 13.79 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 6:triggers (n=40,38,37,41,34,38,39) | -9.7 units on a scale | Standard Deviation 23.61 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Baseline:triggers (n=46,41,42,45,42,41,43) | 46.1 units on a scale | Standard Deviation 29.64 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 1:total (n=45,45,46,47,44,40,43) | -8.9 units on a scale | Standard Deviation 11.43 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 1:symptoms (n=45,45,46,47,44,40,43) | -8.2 units on a scale | Standard Deviation 17.59 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 8:symptoms (n=45,46,46,48,47,43,44) | -11.6 units on a scale | Standard Deviation 20.68 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 1:function (n=43,45,44,47,43,39,39) | -9.1 units on a scale | Standard Deviation 14.77 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 1:triggers (n=43,39,39,43,38,35,39) | -10.2 units on a scale | Standard Deviation 18.88 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 2:total (n=44,46,45,48,45,43,44) | -8.9 units on a scale | Standard Deviation 13.08 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 2:symptoms (n=44,46,45,48,45,43,44) | -11.5 units on a scale | Standard Deviation 18.12 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 2:function (n=42,46,42,48,43,43,41) | -7.6 units on a scale | Standard Deviation 16.52 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 2:triggers (n=42,40,40,38,35,39,40) | -9.4 units on a scale | Standard Deviation 16.6 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 4:total (n=44,43,44,48,44,41,43) | -9.7 units on a scale | Standard Deviation 14.12 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 8:function (n=44,46,45,48,46,43,41) | -9.2 units on a scale | Standard Deviation 18.33 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 4:symptoms (n=44,43,44,48,44,41,43) | -10.9 units on a scale | Standard Deviation 18.37 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 4:function (n=43,42,42,47,41,41,40) | -8.5 units on a scale | Standard Deviation 16.77 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 4:triggers (n=43,36,39,43,36,37,39) | -9.8 units on a scale | Standard Deviation 23.23 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 6:total (n=43,44,42,48,42,41,43) | -10.9 units on a scale | Standard Deviation 14.33 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 6:symptoms (n=43,44,42,48,42,41,43) | -11.4 units on a scale | Standard Deviation 19.52 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 6:function (n=42,44,38,46,40,41,40) | -9.6 units on a scale | Standard Deviation 14.74 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 6:triggers (n=40,38,37,41,34,38,39) | -9.2 units on a scale | Standard Deviation 24.85 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 8:triggers(n=44,41,42,45,,41,41,41) | -6.4 units on a scale | Standard Deviation 29.08 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 8:total (n=45,46,46,48,32,35,39) | -8.8 units on a scale | Standard Deviation 16.56 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Baseline:total (n=47,46,46,48,48,43,47) | 41.8 units on a scale | Standard Deviation 22.04 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Baseline:symptoms (n=47,46,46,48,48,43,47) | 45.7 units on a scale | Standard Deviation 24.37 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Baseline:function (n=46,46,45,48,47,43,44) | 38.3 units on a scale | Standard Deviation 26.66 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 2:total (n=44,46,45,48,45,43,44) | -4.7 units on a scale | Standard Deviation 19.01 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 8:function (n=44,46,45,48,46,43,41) | -6.2 units on a scale | Standard Deviation 23.86 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Baseline:function (n=46,46,45,48,47,43,44) | 31.8 units on a scale | Standard Deviation 20.74 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 6:symptoms (n=43,44,42,48,42,41,43) | -7.1 units on a scale | Standard Deviation 21.03 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 4:total (n=44,43,44,48,44,41,43) | -10.0 units on a scale | Standard Deviation 20.92 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 8:symptoms (n=45,46,46,48,47,43,44) | -10.5 units on a scale | Standard Deviation 23.98 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 6:function (n=42,44,38,46,40,41,40) | -3.7 units on a scale | Standard Deviation 20.1 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 2:function (n=42,46,42,48,43,43,41) | -3.5 units on a scale | Standard Deviation 23.92 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 1:triggers (n=43,39,39,43,38,35,39) | -14.7 units on a scale | Standard Deviation 23.12 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Baseline:triggers (n=46,41,42,45,42,41,43) | 45.6 units on a scale | Standard Deviation 29.52 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 2:symptoms (n=44,46,45,48,45,43,44) | -6.9 units on a scale | Standard Deviation 19.41 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 2:triggers (n=42,40,40,38,35,39,40) | -10.1 units on a scale | Standard Deviation 29 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Baseline:total (n=47,46,46,48,48,43,47) | 37.8 units on a scale | Standard Deviation 18.76 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 4:triggers (n=43,36,39,43,36,37,39) | -16.3 units on a scale | Standard Deviation 29.55 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 4:symptoms (n=44,43,44,48,44,41,43) | -10.8 units on a scale | Standard Deviation 23.47 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 8:triggers(n=44,41,42,45,,41,41,41) | -13.5 units on a scale | Standard Deviation 29.07 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 1:symptoms (n=45,45,46,47,44,40,43) | -6.3 units on a scale | Standard Deviation 20.26 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 8:total (n=45,46,46,48,32,35,39) | -9.5 units on a scale | Standard Deviation 20.92 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Baseline:symptoms (n=47,46,46,48,48,43,47) | 41.7 units on a scale | Standard Deviation 22.87 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 1:total (n=45,45,46,47,44,40,43) | -6.5 units on a scale | Standard Deviation 17.18 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 6:total (n=43,44,42,48,42,41,43) | -8.1 units on a scale | Standard Deviation 20.48 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 4:function (n=43,42,42,47,41,41,40) | -5.1 units on a scale | Standard Deviation 20.37 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 1:function (n=43,45,44,47,43,39,39) | -4.4 units on a scale | Standard Deviation 19.94 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 6:triggers (n=40,38,37,41,34,38,39) | -12.4 units on a scale | Standard Deviation 32.88 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 2:function (n=42,46,42,48,43,43,41) | -7.0 units on a scale | Standard Deviation 19.1 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 2:symptoms (n=44,46,45,48,45,43,44) | -9.7 units on a scale | Standard Deviation 21.74 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 4:function (n=43,42,42,47,41,41,40) | -7.3 units on a scale | Standard Deviation 18.75 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 8:function (n=44,46,45,48,46,43,41) | -9.2 units on a scale | Standard Deviation 18.31 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 4:triggers (n=43,36,39,43,36,37,39) | -21.5 units on a scale | Standard Deviation 25.07 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 2:total (n=44,46,45,48,45,43,44) | -10.3 units on a scale | Standard Deviation 20.16 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 6:total (n=43,44,42,48,42,41,43) | -14.0 units on a scale | Standard Deviation 19.43 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 8:symptoms (n=45,46,46,48,47,43,44) | -14.3 units on a scale | Standard Deviation 21.54 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 6:symptoms (n=43,44,42,48,42,41,43) | -13.4 units on a scale | Standard Deviation 21.8 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 1:triggers (n=43,39,39,43,38,35,39) | -15.0 units on a scale | Standard Deviation 28.19 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 6:function (n=42,44,38,46,40,41,40) | -9.3 units on a scale | Standard Deviation 19.34 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 1:function (n=43,45,44,47,43,39,39) | -9.1 units on a scale | Standard Deviation 17.81 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 6:triggers (n=40,38,37,41,34,38,39) | -24.5 units on a scale | Standard Deviation 28.3 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Baseline:function (n=46,46,45,48,47,43,44) | 31.3 units on a scale | Standard Deviation 27.07 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 1:symptoms (n=45,45,46,47,44,40,43) | -6.9 units on a scale | Standard Deviation 17.99 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Baseline:total (n=47,46,46,48,48,43,47) | 35.6 units on a scale | Standard Deviation 22.45 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 8:total (n=45,46,46,48,32,35,39) | -12.7 units on a scale | Standard Deviation 18.21 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 1:total (n=45,45,46,47,44,40,43) | -9.2 units on a scale | Standard Deviation 17.13 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 2:triggers (n=42,40,40,38,35,39,40) | -19.2 units on a scale | Standard Deviation 29.05 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 4:symptoms (n=44,43,44,48,44,41,43) | -10.4 units on a scale | Standard Deviation 18.61 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Baseline:triggers (n=46,41,42,45,42,41,43) | 44.8 units on a scale | Standard Deviation 26.92 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 4:total (n=44,43,44,48,44,41,43) | -11.3 units on a scale | Standard Deviation 17.12 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 8:triggers(n=44,41,42,45,,41,41,41) | -19.6 units on a scale | Standard Deviation 26.06 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Baseline:symptoms (n=47,46,46,48,48,43,47) | 35.9 units on a scale | Standard Deviation 20.86 |
| Restasis Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 2:total (n=44,46,45,48,45,43,44) | -7.3 units on a scale | Standard Deviation 16.51 |
| Restasis Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Baseline:symptoms (n=47,46,46,48,48,43,47) | 47.3 units on a scale | Standard Deviation 24.64 |
| Restasis Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 8:function (n=44,46,45,48,46,43,41) | -6.8 units on a scale | Standard Deviation 19.72 |
| Restasis Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 4:triggers (n=43,36,39,43,36,37,39) | -4.7 units on a scale | Standard Deviation 20.9 |
| Restasis Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 8:total (n=45,46,46,48,32,35,39) | -6.6 units on a scale | Standard Deviation 16.11 |
| Restasis Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 2:symptoms (n=44,46,45,48,45,43,44) | -7.6 units on a scale | Standard Deviation 17.77 |
| Restasis Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Baseline:total (n=47,46,46,48,48,43,47) | 41.8 units on a scale | Standard Deviation 22.93 |
| Restasis Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 4:function (n=43,42,42,47,41,41,40) | -8.7 units on a scale | Standard Deviation 17.83 |
| Restasis Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 1:total (n=45,45,46,47,44,40,43) | -4.7 units on a scale | Standard Deviation 12.46 |
| Restasis Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 4:symptoms (n=44,43,44,48,44,41,43) | -6.6 units on a scale | Standard Deviation 15.06 |
| Restasis Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 1:triggers (n=43,39,39,43,38,35,39) | -2.4 units on a scale | Standard Deviation 18.97 |
| Restasis Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 4:total (n=44,43,44,48,44,41,43) | -7.0 units on a scale | Standard Deviation 13.95 |
| Restasis Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 6:function (n=42,44,38,46,40,41,40) | -8.3 units on a scale | Standard Deviation 17.09 |
| Restasis Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 6:symptoms (n=43,44,42,48,42,41,43) | -9.1 units on a scale | Standard Deviation 15.52 |
| Restasis Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 1:function (n=43,45,44,47,43,39,39) | -7.3 units on a scale | Standard Deviation 16.84 |
| Restasis Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 2:triggers (n=42,40,40,38,35,39,40) | -5.5 units on a scale | Standard Deviation 21.42 |
| Restasis Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Baseline:triggers (n=46,41,42,45,42,41,43) | 50.3 units on a scale | Standard Deviation 30.12 |
| Restasis Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 8:triggers(n=44,41,42,45,,41,41,41) | -4.8 units on a scale | Standard Deviation 23.62 |
| Restasis Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 8:symptoms (n=45,46,46,48,47,43,44) | -7.4 units on a scale | Standard Deviation 17.72 |
| Restasis Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 6:triggers (n=40,38,37,41,34,38,39) | -5.9 units on a scale | Standard Deviation 22.65 |
| Restasis Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 2:function (n=42,46,42,48,43,43,41) | -8.6 units on a scale | Standard Deviation 19.44 |
| Restasis Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 6:total (n=43,44,42,48,42,41,43) | -7.7 units on a scale | Standard Deviation 14 |
| Restasis Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Change at Week 1:symptoms (n=45,45,46,47,44,40,43) | -4.5 units on a scale | Standard Deviation 13.03 |
| Restasis Twice Daily | Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8 | Baseline:function (n=46,46,45,48,47,43,44) | 36.1 units on a scale | Standard Deviation 26.02 |
Secondary
Change From Baseline in Schirmer Wetting Score With Anesthesia at Week 8
Schirmer test was performed 2 to 3 minutes after 1 drop of proparacaine 0.5% was placed in lower conjunctival fornix and superior bulbar conjunctiva of each eye. It was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
Time frame: Baseline, Week 8
Population: ITT population included all enrolled participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Twice Daily | Change From Baseline in Schirmer Wetting Score With Anesthesia at Week 8 | Baseline (n=47,46,47,48,48,43,47) | 6.56 mm | Standard Deviation 4.69 |
| Placebo Twice Daily | Change From Baseline in Schirmer Wetting Score With Anesthesia at Week 8 | Change at Week 8 (n=43,43,45,48,41,39,42) | 2.24 mm | Standard Deviation 5.07 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Schirmer Wetting Score With Anesthesia at Week 8 | Baseline (n=47,46,47,48,48,43,47) | 7.58 mm | Standard Deviation 4.44 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Schirmer Wetting Score With Anesthesia at Week 8 | Change at Week 8 (n=43,43,45,48,41,39,42) | 0.13 mm | Standard Deviation 5.47 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Schirmer Wetting Score With Anesthesia at Week 8 | Baseline (n=47,46,47,48,48,43,47) | 6.63 mm | Standard Deviation 5.05 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Schirmer Wetting Score With Anesthesia at Week 8 | Change at Week 8 (n=43,43,45,48,41,39,42) | 2.56 mm | Standard Deviation 6.11 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Schirmer Wetting Score With Anesthesia at Week 8 | Baseline (n=47,46,47,48,48,43,47) | 6.67 mm | Standard Deviation 4.01 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Schirmer Wetting Score With Anesthesia at Week 8 | Change at Week 8 (n=43,43,45,48,41,39,42) | 1.48 mm | Standard Deviation 5.48 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Schirmer Wetting Score With Anesthesia at Week 8 | Baseline (n=47,46,47,48,48,43,47) | 7.85 mm | Standard Deviation 5.35 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Schirmer Wetting Score With Anesthesia at Week 8 | Change at Week 8 (n=43,43,45,48,41,39,42) | -0.44 mm | Standard Deviation 5.13 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Schirmer Wetting Score With Anesthesia at Week 8 | Baseline (n=47,46,47,48,48,43,47) | 7.92 mm | Standard Deviation 5.13 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Schirmer Wetting Score With Anesthesia at Week 8 | Change at Week 8 (n=43,43,45,48,41,39,42) | 0.83 mm | Standard Deviation 6.04 |
| Restasis Twice Daily | Change From Baseline in Schirmer Wetting Score With Anesthesia at Week 8 | Baseline (n=47,46,47,48,48,43,47) | 8.14 mm | Standard Deviation 5.75 |
| Restasis Twice Daily | Change From Baseline in Schirmer Wetting Score With Anesthesia at Week 8 | Change at Week 8 (n=43,43,45,48,41,39,42) | 1.74 mm | Standard Deviation 5.74 |
Secondary
Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8
Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
Time frame: Baseline, Week 1, 2, 4, 6, 8
Population: ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. Here, 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Twice Daily | Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8 | Change at Week 8 (n=45,46,47,48,47,44,45) | 1.89 mm | Standard Deviation 5.22 |
| Placebo Twice Daily | Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8 | Change at Week 1 (n=45,45,47,47,44,42,43) | 2.06 mm | Standard Deviation 4.54 |
| Placebo Twice Daily | Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8 | Change at Week 4 (n=44,43,45,48,44,39,43) | 2.42 mm | Standard Deviation 6.64 |
| Placebo Twice Daily | Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8 | Baseline (n=47,46,47,48,48,44,47) | 4.15 mm | Standard Deviation 2.07 |
| Placebo Twice Daily | Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8 | Change at Week 2 (n=44,46,46,48,45,44,44) | 2.43 mm | Standard Deviation 4.98 |
| Placebo Twice Daily | Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8 | Change at Week 6 (n=43,44,43,47,42,41,43) | 1.86 mm | Standard Deviation 3.82 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8 | Baseline (n=47,46,47,48,48,44,47) | 4.40 mm | Standard Deviation 2.2 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8 | Change at Week 4 (n=44,43,45,48,44,39,43) | 2.69 mm | Standard Deviation 4.56 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8 | Change at Week 8 (n=45,46,47,48,47,44,45) | 2.30 mm | Standard Deviation 4.73 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8 | Change at Week 1 (n=45,45,47,47,44,42,43) | 1.68 mm | Standard Deviation 4.69 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8 | Change at Week 6 (n=43,44,43,47,42,41,43) | 1.41 mm | Standard Deviation 3.27 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8 | Change at Week 2 (n=44,46,46,48,45,44,44) | 1.63 mm | Standard Deviation 4.04 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8 | Change at Week 6 (n=43,44,43,47,42,41,43) | 1.59 mm | Standard Deviation 3.55 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8 | Change at Week 2 (n=44,46,46,48,45,44,44) | 2.67 mm | Standard Deviation 4.44 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8 | Change at Week 8 (n=45,46,47,48,47,44,45) | 2.19 mm | Standard Deviation 4.22 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8 | Change at Week 4 (n=44,43,45,48,44,39,43) | 2.56 mm | Standard Deviation 4.76 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8 | Baseline (n=47,46,47,48,48,44,47) | 4.02 mm | Standard Deviation 2.12 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8 | Change at Week 1 (n=45,45,47,47,44,42,43) | 0.80 mm | Standard Deviation 3.03 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8 | Change at Week 6 (n=43,44,43,47,42,41,43) | 1.76 mm | Standard Deviation 4.11 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8 | Baseline (n=47,46,47,48,48,44,47) | 3.77 mm | Standard Deviation 1.87 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8 | Change at Week 1 (n=45,45,47,47,44,42,43) | 2.07 mm | Standard Deviation 3.87 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8 | Change at Week 2 (n=44,46,46,48,45,44,44) | 3.13 mm | Standard Deviation 4.61 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8 | Change at Week 4 (n=44,43,45,48,44,39,43) | 1.72 mm | Standard Deviation 3.6 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8 | Change at Week 8 (n=45,46,47,48,47,44,45) | 3.59 mm | Standard Deviation 6.22 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8 | Change at Week 4 (n=44,43,45,48,44,39,43) | 1.66 mm | Standard Deviation 5.03 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8 | Change at Week 1 (n=45,45,47,47,44,42,43) | 1.80 mm | Standard Deviation 4.64 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8 | Change at Week 6 (n=43,44,43,47,42,41,43) | 3.64 mm | Standard Deviation 6.57 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8 | Change at Week 8 (n=45,46,47,48,47,44,45) | 2.60 mm | Standard Deviation 4.8 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8 | Change at Week 2 (n=44,46,46,48,45,44,44) | 2.74 mm | Standard Deviation 4.6 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8 | Baseline (n=47,46,47,48,48,44,47) | 4.43 mm | Standard Deviation 2.29 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8 | Change at Week 2 (n=44,46,46,48,45,44,44) | 3.43 mm | Standard Deviation 6.62 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8 | Change at Week 4 (n=44,43,45,48,44,39,43) | 4.21 mm | Standard Deviation 7.03 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8 | Change at Week 1 (n=45,45,47,47,44,42,43) | 2.68 mm | Standard Deviation 6.11 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8 | Change at Week 6 (n=43,44,43,47,42,41,43) | 4.65 mm | Standard Deviation 6.3 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8 | Baseline (n=47,46,47,48,48,44,47) | 4.40 mm | Standard Deviation 2.24 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8 | Change at Week 8 (n=45,46,47,48,47,44,45) | 3.76 mm | Standard Deviation 6.28 |
| Restasis Twice Daily | Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8 | Change at Week 2 (n=44,46,46,48,45,44,44) | 3.84 mm | Standard Deviation 5.66 |
| Restasis Twice Daily | Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8 | Change at Week 1 (n=45,45,47,47,44,42,43) | 3.60 mm | Standard Deviation 5.44 |
| Restasis Twice Daily | Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8 | Change at Week 8 (n=45,46,47,48,47,44,45) | 4.48 mm | Standard Deviation 7.05 |
| Restasis Twice Daily | Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8 | Change at Week 4 (n=44,43,45,48,44,39,43) | 4.06 mm | Standard Deviation 6.65 |
| Restasis Twice Daily | Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8 | Change at Week 6 (n=43,44,43,47,42,41,43) | 3.87 mm | Standard Deviation 5.75 |
| Restasis Twice Daily | Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8 | Baseline (n=47,46,47,48,48,44,47) | 4.74 mm | Standard Deviation 2.03 |
Secondary
Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8
TBUT was the time interval between the last complete blink and the first appearance of a dry spot, or disruption in the tear film. It was measured under a slit lamp following instillation of fluorescein dye in the eye using a stopwatch. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
Time frame: Baseline, Week 1, 2, 4, 6, 8
Population: ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Twice Daily | Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8 | Change at Week 8 (n=45,46,47,48,47,43,45) | 0.55 seconds | Standard Deviation 2.19 |
| Placebo Twice Daily | Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8 | Change at Week 1 (n=45,45,47,47,44,42,44) | 0.17 seconds | Standard Deviation 1.63 |
| Placebo Twice Daily | Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8 | Change at Week 4 (n=44,43,45,48,44,39,43) | 0.48 seconds | Standard Deviation 2.14 |
| Placebo Twice Daily | Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8 | Baseline (n=47,46,47,48,48,43,47) | 3.50 seconds | Standard Deviation 1.32 |
| Placebo Twice Daily | Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8 | Change at Week 2 (n=44,46,46,48,45,43,44) | 0.03 seconds | Standard Deviation 1.4 |
| Placebo Twice Daily | Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8 | Change at Week 6 (n=43,44,43,48,42,41,43) | 1.03 seconds | Standard Deviation 4.65 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8 | Baseline (n=47,46,47,48,48,43,47) | 3.96 seconds | Standard Deviation 3.3 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8 | Change at Week 4 (n=44,43,45,48,44,39,43) | 0.61 seconds | Standard Deviation 2.95 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8 | Change at Week 8 (n=45,46,47,48,47,43,45) | 0.51 seconds | Standard Deviation 2.93 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8 | Change at Week 1 (n=45,45,47,47,44,42,44) | 0.60 seconds | Standard Deviation 2.11 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8 | Change at Week 6 (n=43,44,43,48,42,41,43) | 0.36 seconds | Standard Deviation 2.77 |
| CP-690,550, 0.0003% Twice Daily | Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8 | Change at Week 2 (n=44,46,46,48,45,43,44) | 1.04 seconds | Standard Deviation 4.49 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8 | Change at Week 6 (n=43,44,43,48,42,41,43) | -0.01 seconds | Standard Deviation 2.46 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8 | Change at Week 2 (n=44,46,46,48,45,43,44) | 0.24 seconds | Standard Deviation 3.08 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8 | Change at Week 8 (n=45,46,47,48,47,43,45) | -0.18 seconds | Standard Deviation 2.3 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8 | Change at Week 4 (n=44,43,45,48,44,39,43) | -0.11 seconds | Standard Deviation 2.31 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8 | Baseline (n=47,46,47,48,48,43,47) | 4.32 seconds | Standard Deviation 2.74 |
| CP-690,550, 0.001% Twice Daily | Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8 | Change at Week 1 (n=45,45,47,47,44,42,44) | 0.21 seconds | Standard Deviation 2.5 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8 | Change at Week 6 (n=43,44,43,48,42,41,43) | -0.71 seconds | Standard Deviation 4.85 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8 | Baseline (n=47,46,47,48,48,43,47) | 4.65 seconds | Standard Deviation 6.5 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8 | Change at Week 1 (n=45,45,47,47,44,42,44) | -0.27 seconds | Standard Deviation 1.55 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8 | Change at Week 2 (n=44,46,46,48,45,43,44) | -0.44 seconds | Standard Deviation 3.8 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8 | Change at Week 4 (n=44,43,45,48,44,39,43) | -0.30 seconds | Standard Deviation 4.21 |
| CP-690,550, 0.003% Twice Daily | Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8 | Change at Week 8 (n=45,46,47,48,47,43,45) | -0.04 seconds | Standard Deviation 5.01 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8 | Change at Week 4 (n=44,43,45,48,44,39,43) | 0.10 seconds | Standard Deviation 1.5 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8 | Change at Week 1 (n=45,45,47,47,44,42,44) | -0.07 seconds | Standard Deviation 1.26 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8 | Change at Week 6 (n=43,44,43,48,42,41,43) | 0.13 seconds | Standard Deviation 1.45 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8 | Change at Week 8 (n=45,46,47,48,47,43,45) | 0.08 seconds | Standard Deviation 1.5 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8 | Change at Week 2 (n=44,46,46,48,45,43,44) | -0.18 seconds | Standard Deviation 1.01 |
| CP-690,550, 0.005% Twice Daily | Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8 | Baseline (n=47,46,47,48,48,43,47) | 4.12 seconds | Standard Deviation 2.44 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8 | Change at Week 2 (n=44,46,46,48,45,43,44) | 0.04 seconds | Standard Deviation 2.59 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8 | Change at Week 4 (n=44,43,45,48,44,39,43) | -0.08 seconds | Standard Deviation 2.37 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8 | Change at Week 1 (n=45,45,47,47,44,42,44) | -0.51 seconds | Standard Deviation 2.24 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8 | Change at Week 6 (n=43,44,43,48,42,41,43) | -0.21 seconds | Standard Deviation 2.51 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8 | Baseline (n=47,46,47,48,48,43,47) | 3.90 seconds | Standard Deviation 2.47 |
| CP-690,550, 0.005% Once Daily | Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8 | Change at Week 8 (n=45,46,47,48,47,43,45) | 0.31 seconds | Standard Deviation 3.54 |
| Restasis Twice Daily | Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8 | Change at Week 2 (n=44,46,46,48,45,43,44) | 0.36 seconds | Standard Deviation 2.96 |
| Restasis Twice Daily | Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8 | Change at Week 1 (n=45,45,47,47,44,42,44) | -0.14 seconds | Standard Deviation 2 |
| Restasis Twice Daily | Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8 | Change at Week 8 (n=45,46,47,48,47,43,45) | 0.52 seconds | Standard Deviation 3.07 |
| Restasis Twice Daily | Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8 | Change at Week 4 (n=44,43,45,48,44,39,43) | 0.52 seconds | Standard Deviation 2.43 |
| Restasis Twice Daily | Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8 | Change at Week 6 (n=43,44,43,48,42,41,43) | 0.59 seconds | Standard Deviation 3.32 |
| Restasis Twice Daily | Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8 | Baseline (n=47,46,47,48,48,43,47) | 3.95 seconds | Standard Deviation 2.3 |
Secondary
Change From Baseline Ocular Surface Disease Index (OSDI) Raw Score at Week 1, 2, 4, 6 and 8
OSDI is a validated instrument for ocular surface disease. It has 12 items, each with a raw score measured on 5-point Likert scale (0=none of the time, 4=all the time).
Time frame: Baseline, Week 1, 2, 4, 6, 8
Population: Data for OSDI raw score was not analyzed due to the exploratory nature and overwhelming amount of data derived from the analysis.
Secondary
Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score With Anesthesia at Week 8
Schirmer test was performed 2 to 3 minutes after 1 drop of proparacaine 0.5% was placed in lower conjunctival fornix and superior bulbar conjunctiva of each eye. It was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
Time frame: Week 8
Population: ITT population included all enrolled participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Twice Daily | Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score With Anesthesia at Week 8 | 32.6 percentage of participants |
| CP-690,550, 0.0003% Twice Daily | Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score With Anesthesia at Week 8 | 27.9 percentage of participants |
| CP-690,550, 0.001% Twice Daily | Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score With Anesthesia at Week 8 | 48.9 percentage of participants |
| CP-690,550, 0.003% Twice Daily | Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score With Anesthesia at Week 8 | 31.3 percentage of participants |
| CP-690,550, 0.005% Twice Daily | Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score With Anesthesia at Week 8 | 24.4 percentage of participants |
| CP-690,550, 0.005% Once Daily | Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score With Anesthesia at Week 8 | 25.6 percentage of participants |
| Restasis Twice Daily | Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score With Anesthesia at Week 8 | 38.1 percentage of participants |
Secondary
Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4 and 6
Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
Time frame: Week 1, 2, 4, 6
Population: ITT population included all enrolled participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) included those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo Twice Daily | Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4 and 6 | Week 1 | 20.0 percentage of participants |
| Placebo Twice Daily | Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4 and 6 | Week 2 | 18.2 percentage of participants |
| Placebo Twice Daily | Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4 and 6 | Week 4 | 18.2 percentage of participants |
| Placebo Twice Daily | Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4 and 6 | Week 6 | 20.9 percentage of participants |
| CP-690,550, 0.0003% Twice Daily | Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4 and 6 | Week 6 | 9.1 percentage of participants |
| CP-690,550, 0.0003% Twice Daily | Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4 and 6 | Week 4 | 20.9 percentage of participants |
| CP-690,550, 0.0003% Twice Daily | Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4 and 6 | Week 1 | 9.1 percentage of participants |
| CP-690,550, 0.0003% Twice Daily | Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4 and 6 | Week 2 | 20.0 percentage of participants |
| CP-690,550, 0.001% Twice Daily | Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4 and 6 | Week 4 | 17.8 percentage of participants |
| CP-690,550, 0.001% Twice Daily | Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4 and 6 | Week 2 | 23.9 percentage of participants |
| CP-690,550, 0.001% Twice Daily | Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4 and 6 | Week 1 | 6.4 percentage of participants |
| CP-690,550, 0.001% Twice Daily | Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4 and 6 | Week 6 | 16.3 percentage of participants |
| CP-690,550, 0.003% Twice Daily | Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4 and 6 | Week 1 | 14.9 percentage of participants |
| CP-690,550, 0.003% Twice Daily | Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4 and 6 | Week 2 | 16.7 percentage of participants |
| CP-690,550, 0.003% Twice Daily | Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4 and 6 | Week 4 | 10.4 percentage of participants |
| CP-690,550, 0.003% Twice Daily | Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4 and 6 | Week 6 | 12.8 percentage of participants |
| CP-690,550, 0.005% Twice Daily | Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4 and 6 | Week 1 | 11.6 percentage of participants |
| CP-690,550, 0.005% Twice Daily | Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4 and 6 | Week 6 | 34.1 percentage of participants |
| CP-690,550, 0.005% Twice Daily | Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4 and 6 | Week 2 | 25.0 percentage of participants |
| CP-690,550, 0.005% Twice Daily | Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4 and 6 | Week 4 | 16.3 percentage of participants |
| CP-690,550, 0.005% Once Daily | Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4 and 6 | Week 2 | 22.7 percentage of participants |
| CP-690,550, 0.005% Once Daily | Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4 and 6 | Week 1 | 16.7 percentage of participants |
| CP-690,550, 0.005% Once Daily | Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4 and 6 | Week 4 | 28.2 percentage of participants |
| CP-690,550, 0.005% Once Daily | Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4 and 6 | Week 6 | 39.0 percentage of participants |
| Restasis Twice Daily | Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4 and 6 | Week 4 | 30.2 percentage of participants |
| Restasis Twice Daily | Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4 and 6 | Week 1 | 30.2 percentage of participants |
| Restasis Twice Daily | Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4 and 6 | Week 2 | 36.4 percentage of participants |
| Restasis Twice Daily | Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4 and 6 | Week 6 | 34.9 percentage of participants |
Secondary
Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining
Corneal staining was assessed using fluorescein dye, yellow filter, slit lamp. Cornea was divided into 5 different zones. Each corneal zone was graded independently using 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. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
Time frame: Week 1, 2, 4, 6, 8
Population: ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo Twice Daily | Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining | Week 4 | 4.5 percentage of participants |
| Placebo Twice Daily | Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining | Week 8 | 6.7 percentage of participants |
| Placebo Twice Daily | Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining | Week 1 | 2.2 percentage of participants |
| Placebo Twice Daily | Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining | Week 6 | 4.7 percentage of participants |
| Placebo Twice Daily | Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining | Week 2 | 2.3 percentage of participants |
| CP-690,550, 0.0003% Twice Daily | Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining | Week 1 | 0.0 percentage of participants |
| CP-690,550, 0.0003% Twice Daily | Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining | Week 4 | 2.3 percentage of participants |
| CP-690,550, 0.0003% Twice Daily | Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining | Week 8 | 6.5 percentage of participants |
| CP-690,550, 0.0003% Twice Daily | Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining | Week 2 | 4.3 percentage of participants |
| CP-690,550, 0.0003% Twice Daily | Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining | Week 6 | 6.8 percentage of participants |
| CP-690,550, 0.001% Twice Daily | Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining | Week 1 | 0.0 percentage of participants |
| CP-690,550, 0.001% Twice Daily | Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining | Week 8 | 4.3 percentage of participants |
| CP-690,550, 0.001% Twice Daily | Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining | Week 2 | 0.0 percentage of participants |
| CP-690,550, 0.001% Twice Daily | Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining | Week 4 | 4.4 percentage of participants |
| CP-690,550, 0.001% Twice Daily | Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining | Week 6 | 7.0 percentage of participants |
| CP-690,550, 0.003% Twice Daily | Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining | Week 6 | 4.2 percentage of participants |
| CP-690,550, 0.003% Twice Daily | Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining | Week 1 | 0.0 percentage of participants |
| CP-690,550, 0.003% Twice Daily | Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining | Week 2 | 4.2 percentage of participants |
| CP-690,550, 0.003% Twice Daily | Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining | Week 8 | 10.4 percentage of participants |
| CP-690,550, 0.003% Twice Daily | Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining | Week 4 | 6.3 percentage of participants |
| CP-690,550, 0.005% Twice Daily | Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining | Week 4 | 2.3 percentage of participants |
| CP-690,550, 0.005% Twice Daily | Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining | Week 2 | 0.0 percentage of participants |
| CP-690,550, 0.005% Twice Daily | Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining | Week 8 | 6.4 percentage of participants |
| CP-690,550, 0.005% Twice Daily | Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining | Week 1 | 0.0 percentage of participants |
| CP-690,550, 0.005% Twice Daily | Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining | Week 6 | 7.1 percentage of participants |
| CP-690,550, 0.005% Once Daily | Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining | Week 8 | 15.9 percentage of participants |
| CP-690,550, 0.005% Once Daily | Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining | Week 1 | 4.8 percentage of participants |
| CP-690,550, 0.005% Once Daily | Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining | Week 2 | 4.5 percentage of participants |
| CP-690,550, 0.005% Once Daily | Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining | Week 4 | 2.6 percentage of participants |
| CP-690,550, 0.005% Once Daily | Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining | Week 6 | 7.3 percentage of participants |
| Restasis Twice Daily | Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining | Week 6 | 7.0 percentage of participants |
| Restasis Twice Daily | Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining | Week 4 | 4.7 percentage of participants |
| Restasis Twice Daily | Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining | Week 2 | 0.0 percentage of participants |
| Restasis Twice Daily | Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining | Week 1 | 0.0 percentage of participants |
| Restasis Twice Daily | Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining | Week 8 | 4.5 percentage of participants |
Secondary
Percentage of Participants With >= 10 Units Decrease in Total OSDI Score
OSDI is a validated instrument for ocular surface disease. It has 12 items, each has a raw score measured on 5-point Likert scale (0=none of the time, 4=all the time). Based on these item scores, a total OSDI score can be derived which ranges from 0 to 100; a higher score indicates worse ocular disease.
Time frame: Week 1, 2, 4, 6, 8
Population: ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo Twice Daily | Percentage of Participants With >= 10 Units Decrease in Total OSDI Score | Week 4 | 47.7 percentage of participants |
| Placebo Twice Daily | Percentage of Participants With >= 10 Units Decrease in Total OSDI Score | Week 8 | 40.0 percentage of participants |
| Placebo Twice Daily | Percentage of Participants With >= 10 Units Decrease in Total OSDI Score | Week 1 | 37.8 percentage of participants |
| Placebo Twice Daily | Percentage of Participants With >= 10 Units Decrease in Total OSDI Score | Week 6 | 46.5 percentage of participants |
| Placebo Twice Daily | Percentage of Participants With >= 10 Units Decrease in Total OSDI Score | Week 2 | 50.0 percentage of participants |
| CP-690,550, 0.0003% Twice Daily | Percentage of Participants With >= 10 Units Decrease in Total OSDI Score | Week 1 | 37.8 percentage of participants |
| CP-690,550, 0.0003% Twice Daily | Percentage of Participants With >= 10 Units Decrease in Total OSDI Score | Week 4 | 44.2 percentage of participants |
| CP-690,550, 0.0003% Twice Daily | Percentage of Participants With >= 10 Units Decrease in Total OSDI Score | Week 8 | 50.0 percentage of participants |
| CP-690,550, 0.0003% Twice Daily | Percentage of Participants With >= 10 Units Decrease in Total OSDI Score | Week 2 | 45.7 percentage of participants |
| CP-690,550, 0.0003% Twice Daily | Percentage of Participants With >= 10 Units Decrease in Total OSDI Score | Week 6 | 52.3 percentage of participants |
| CP-690,550, 0.001% Twice Daily | Percentage of Participants With >= 10 Units Decrease in Total OSDI Score | Week 1 | 34.8 percentage of participants |
| CP-690,550, 0.001% Twice Daily | Percentage of Participants With >= 10 Units Decrease in Total OSDI Score | Week 8 | 41.3 percentage of participants |
| CP-690,550, 0.001% Twice Daily | Percentage of Participants With >= 10 Units Decrease in Total OSDI Score | Week 2 | 40.0 percentage of participants |
| CP-690,550, 0.001% Twice Daily | Percentage of Participants With >= 10 Units Decrease in Total OSDI Score | Week 4 | 38.6 percentage of participants |
| CP-690,550, 0.001% Twice Daily | Percentage of Participants With >= 10 Units Decrease in Total OSDI Score | Week 6 | 35.7 percentage of participants |
| CP-690,550, 0.003% Twice Daily | Percentage of Participants With >= 10 Units Decrease in Total OSDI Score | Week 6 | 52.1 percentage of participants |
| CP-690,550, 0.003% Twice Daily | Percentage of Participants With >= 10 Units Decrease in Total OSDI Score | Week 1 | 46.8 percentage of participants |
| CP-690,550, 0.003% Twice Daily | Percentage of Participants With >= 10 Units Decrease in Total OSDI Score | Week 2 | 43.8 percentage of participants |
| CP-690,550, 0.003% Twice Daily | Percentage of Participants With >= 10 Units Decrease in Total OSDI Score | Week 8 | 47.9 percentage of participants |
| CP-690,550, 0.003% Twice Daily | Percentage of Participants With >= 10 Units Decrease in Total OSDI Score | Week 4 | 50.0 percentage of participants |
| CP-690,550, 0.005% Twice Daily | Percentage of Participants With >= 10 Units Decrease in Total OSDI Score | Week 4 | 45.5 percentage of participants |
| CP-690,550, 0.005% Twice Daily | Percentage of Participants With >= 10 Units Decrease in Total OSDI Score | Week 2 | 33.3 percentage of participants |
| CP-690,550, 0.005% Twice Daily | Percentage of Participants With >= 10 Units Decrease in Total OSDI Score | Week 8 | 44.7 percentage of participants |
| CP-690,550, 0.005% Twice Daily | Percentage of Participants With >= 10 Units Decrease in Total OSDI Score | Week 1 | 45.5 percentage of participants |
| CP-690,550, 0.005% Twice Daily | Percentage of Participants With >= 10 Units Decrease in Total OSDI Score | Week 6 | 40.5 percentage of participants |
| CP-690,550, 0.005% Once Daily | Percentage of Participants With >= 10 Units Decrease in Total OSDI Score | Week 8 | 46.5 percentage of participants |
| CP-690,550, 0.005% Once Daily | Percentage of Participants With >= 10 Units Decrease in Total OSDI Score | Week 1 | 40.0 percentage of participants |
| CP-690,550, 0.005% Once Daily | Percentage of Participants With >= 10 Units Decrease in Total OSDI Score | Week 2 | 39.5 percentage of participants |
| CP-690,550, 0.005% Once Daily | Percentage of Participants With >= 10 Units Decrease in Total OSDI Score | Week 4 | 41.5 percentage of participants |
| CP-690,550, 0.005% Once Daily | Percentage of Participants With >= 10 Units Decrease in Total OSDI Score | Week 6 | 51.2 percentage of participants |
| Restasis Twice Daily | Percentage of Participants With >= 10 Units Decrease in Total OSDI Score | Week 6 | 39.5 percentage of participants |
| Restasis Twice Daily | Percentage of Participants With >= 10 Units Decrease in Total OSDI Score | Week 4 | 44.2 percentage of participants |
| Restasis Twice Daily | Percentage of Participants With >= 10 Units Decrease in Total OSDI Score | Week 2 | 43.2 percentage of participants |
| Restasis Twice Daily | Percentage of Participants With >= 10 Units Decrease in Total OSDI Score | Week 1 | 37.2 percentage of participants |
| Restasis Twice Daily | Percentage of Participants With >= 10 Units Decrease in Total OSDI Score | Week 8 | 38.6 percentage of participants |
Secondary
Percentage of Participants With >= 5 Units Decrease in Total OCI Score
OCI: validated questionnaire 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 Likert scale ranging from 0 (never) to 6 (always/severe). Total score was transformed to range of 0 to 100, higher score indicated more ocular discomfort.
Time frame: Week 1, 2, 4, 6, 8
Population: ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo Twice Daily | Percentage of Participants With >= 5 Units Decrease in Total OCI Score | Week 4 | 68.2 percentage of participants |
| Placebo Twice Daily | Percentage of Participants With >= 5 Units Decrease in Total OCI Score | Week 1 | 44.4 percentage of participants |
| Placebo Twice Daily | Percentage of Participants With >= 5 Units Decrease in Total OCI Score | Week 8 | 64.4 percentage of participants |
| Placebo Twice Daily | Percentage of Participants With >= 5 Units Decrease in Total OCI Score | Week 2 | 56.8 percentage of participants |
| Placebo Twice Daily | Percentage of Participants With >= 5 Units Decrease in Total OCI Score | Week 6 | 72.1 percentage of participants |
| CP-690,550, 0.0003% Twice Daily | Percentage of Participants With >= 5 Units Decrease in Total OCI Score | Week 4 | 60.5 percentage of participants |
| CP-690,550, 0.0003% Twice Daily | Percentage of Participants With >= 5 Units Decrease in Total OCI Score | Week 2 | 52.2 percentage of participants |
| CP-690,550, 0.0003% Twice Daily | Percentage of Participants With >= 5 Units Decrease in Total OCI Score | Week 6 | 68.2 percentage of participants |
| CP-690,550, 0.0003% Twice Daily | Percentage of Participants With >= 5 Units Decrease in Total OCI Score | Week 1 | 53.3 percentage of participants |
| CP-690,550, 0.0003% Twice Daily | Percentage of Participants With >= 5 Units Decrease in Total OCI Score | Week 8 | 71.7 percentage of participants |
| CP-690,550, 0.001% Twice Daily | Percentage of Participants With >= 5 Units Decrease in Total OCI Score | Week 8 | 59.6 percentage of participants |
| CP-690,550, 0.001% Twice Daily | Percentage of Participants With >= 5 Units Decrease in Total OCI Score | Week 2 | 45.7 percentage of participants |
| CP-690,550, 0.001% Twice Daily | Percentage of Participants With >= 5 Units Decrease in Total OCI Score | Week 1 | 38.3 percentage of participants |
| CP-690,550, 0.001% Twice Daily | Percentage of Participants With >= 5 Units Decrease in Total OCI Score | Week 4 | 55.6 percentage of participants |
| CP-690,550, 0.001% Twice Daily | Percentage of Participants With >= 5 Units Decrease in Total OCI Score | Week 6 | 72.1 percentage of participants |
| CP-690,550, 0.003% Twice Daily | Percentage of Participants With >= 5 Units Decrease in Total OCI Score | Week 4 | 58.3 percentage of participants |
| CP-690,550, 0.003% Twice Daily | Percentage of Participants With >= 5 Units Decrease in Total OCI Score | Week 1 | 53.2 percentage of participants |
| CP-690,550, 0.003% Twice Daily | Percentage of Participants With >= 5 Units Decrease in Total OCI Score | Week 2 | 62.5 percentage of participants |
| CP-690,550, 0.003% Twice Daily | Percentage of Participants With >= 5 Units Decrease in Total OCI Score | Week 6 | 62.5 percentage of participants |
| CP-690,550, 0.003% Twice Daily | Percentage of Participants With >= 5 Units Decrease in Total OCI Score | Week 8 | 60.4 percentage of participants |
| CP-690,550, 0.005% Twice Daily | Percentage of Participants With >= 5 Units Decrease in Total OCI Score | Week 1 | 56.8 percentage of participants |
| CP-690,550, 0.005% Twice Daily | Percentage of Participants With >= 5 Units Decrease in Total OCI Score | Week 8 | 57.4 percentage of participants |
| CP-690,550, 0.005% Twice Daily | Percentage of Participants With >= 5 Units Decrease in Total OCI Score | Week 4 | 65.9 percentage of participants |
| CP-690,550, 0.005% Twice Daily | Percentage of Participants With >= 5 Units Decrease in Total OCI Score | Week 6 | 61.9 percentage of participants |
| CP-690,550, 0.005% Twice Daily | Percentage of Participants With >= 5 Units Decrease in Total OCI Score | Week 2 | 57.8 percentage of participants |
| CP-690,550, 0.005% Once Daily | Percentage of Participants With >= 5 Units Decrease in Total OCI Score | Week 1 | 43.9 percentage of participants |
| CP-690,550, 0.005% Once Daily | Percentage of Participants With >= 5 Units Decrease in Total OCI Score | Week 8 | 59.1 percentage of participants |
| CP-690,550, 0.005% Once Daily | Percentage of Participants With >= 5 Units Decrease in Total OCI Score | Week 6 | 51.2 percentage of participants |
| CP-690,550, 0.005% Once Daily | Percentage of Participants With >= 5 Units Decrease in Total OCI Score | Week 2 | 48.8 percentage of participants |
| CP-690,550, 0.005% Once Daily | Percentage of Participants With >= 5 Units Decrease in Total OCI Score | Week 4 | 51.2 percentage of participants |
| Restasis Twice Daily | Percentage of Participants With >= 5 Units Decrease in Total OCI Score | Week 6 | 51.2 percentage of participants |
| Restasis Twice Daily | Percentage of Participants With >= 5 Units Decrease in Total OCI Score | Week 2 | 52.3 percentage of participants |
| Restasis Twice Daily | Percentage of Participants With >= 5 Units Decrease in Total OCI Score | Week 4 | 46.5 percentage of participants |
| Restasis Twice Daily | Percentage of Participants With >= 5 Units Decrease in Total OCI Score | Week 1 | 39.5 percentage of participants |
| Restasis Twice Daily | Percentage of Participants With >= 5 Units Decrease in Total OCI Score | Week 8 | 52.3 percentage of participants |
Secondary
Time to Achieve 100 Percent (%) Clearance of Corneal Staining
Corneal staining was assessed by instilling sodium fluorescein dye in the eye and after 1 to 2 minutes, observing for corneal staining with the aid of a yellow filter and slit lamp. The cornea was divided into five different zones and each corneal zone was graded independently using a 0 to 3 grading scale; where 0=none, 1=slight, 2=moderate, 3=severe. Results from study eye were to be reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
Time frame: Baseline through Week 8
Population: ITT population included all enrolled participants who received at least 1 dose of study medication.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo Twice Daily | Time to Achieve 100 Percent (%) Clearance of Corneal Staining | NA days |
| CP-690,550, 0.0003% Twice Daily | Time to Achieve 100 Percent (%) Clearance of Corneal Staining | NA days |
| CP-690,550, 0.001% Twice Daily | Time to Achieve 100 Percent (%) Clearance of Corneal Staining | NA days |
| CP-690,550, 0.003% Twice Daily | Time to Achieve 100 Percent (%) Clearance of Corneal Staining | NA days |
| CP-690,550, 0.005% Twice Daily | Time to Achieve 100 Percent (%) Clearance of Corneal Staining | NA days |
| CP-690,550, 0.005% Once Daily | Time to Achieve 100 Percent (%) Clearance of Corneal Staining | NA days |
| Restasis Twice Daily | Time to Achieve 100 Percent (%) Clearance of Corneal Staining | NA days |
Secondary
Time to Achieve >= 10mm Schirmer Test Score Without Anesthesia
Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
Time frame: Baseline through Week 8
Population: ITT population included all enrolled participants who received at least 1 dose of study medication.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo Twice Daily | Time to Achieve >= 10mm Schirmer Test Score Without Anesthesia | NA days |
| CP-690,550, 0.0003% Twice Daily | Time to Achieve >= 10mm Schirmer Test Score Without Anesthesia | NA days |
| CP-690,550, 0.001% Twice Daily | Time to Achieve >= 10mm Schirmer Test Score Without Anesthesia | 59.00 days |
| CP-690,550, 0.003% Twice Daily | Time to Achieve >= 10mm Schirmer Test Score Without Anesthesia | 58.00 days |
| CP-690,550, 0.005% Twice Daily | Time to Achieve >= 10mm Schirmer Test Score Without Anesthesia | NA days |
| CP-690,550, 0.005% Once Daily | Time to Achieve >= 10mm Schirmer Test Score Without Anesthesia | 57.00 days |
| Restasis Twice Daily | Time to Achieve >= 10mm Schirmer Test Score Without Anesthesia | NA days |
Secondary
Time to Achieve >= 5 Units Decrease in Ocular Comfort Index (OCI) Score
OCI: validated questionnaire to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contained 12 questions, each measured on a 7-point Likert scale ranging from 0 (never) to 6 (always/severe). Total score was transformed to range of 0 to 100, higher score indicated more ocular discomfort. Negative change from baseline indicated improvement.
Time frame: Baseline through Week 8
Population: ITT population included all enrolled participants who received at least 1 dose of study medication.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo Twice Daily | Time to Achieve >= 5 Units Decrease in Ocular Comfort Index (OCI) Score | 15.00 days |
| CP-690,550, 0.0003% Twice Daily | Time to Achieve >= 5 Units Decrease in Ocular Comfort Index (OCI) Score | 8.50 days |
| CP-690,550, 0.001% Twice Daily | Time to Achieve >= 5 Units Decrease in Ocular Comfort Index (OCI) Score | 15.00 days |
| CP-690,550, 0.003% Twice Daily | Time to Achieve >= 5 Units Decrease in Ocular Comfort Index (OCI) Score | 9.50 days |
| CP-690,550, 0.005% Twice Daily | Time to Achieve >= 5 Units Decrease in Ocular Comfort Index (OCI) Score | 9.00 days |
| CP-690,550, 0.005% Once Daily | Time to Achieve >= 5 Units Decrease in Ocular Comfort Index (OCI) Score | 15.00 days |
| Restasis Twice Daily | Time to Achieve >= 5 Units Decrease in Ocular Comfort Index (OCI) Score | 16.00 days |
80% CI: [9, 28]
80% CI: [8, 27]
80% CI: [15, 27]
80% CI: [8, 15]
80% CI: [8, 15]
80% CI: [8, 43]
80% CI: [15, 30]