Dry Eye
Conditions
Brief summary
The objective of this study was to compare the safety and efficacy of tanfanercept ophthalmic solution 0.25% with placebo for the treatment of the signs and symptoms of dry eye.
Interventions
DRUG0.25% Tanfanercept Ophthalmic Solution
Tanfanercept ophthalmic solution.
DRUGPlacebo
Placebo vehicle solution.
Sponsors
Daewoong Pharmaceutical Co. LTD.
HanAll BioPharma Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have a participant-reported history of dry eye for at least 6 months prior to Visit 1 * Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1 * Have a best-corrected visual acuity (BCVA) of 0.7 minimum angle of resolution (logMAR) or better (Snellen equivalent score of 20/100 or better) in each eye at Visit 1 * Report a score of ≥ 2 according to the Ora Calibra® ocular discomfort & 4-symptom questionnaire in at least one of the dry eye symptoms at Visits 1 and 2 * Have a Schirmer's Test score of ≤ 10 millimeter (mm) and ≥ 1 mm in at least one eye at Visits 1 and 2 * Have a corneal fluorescein staining score ≥ 2 according to the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining in at least 1 of the corneal regions (inferior, superior, or central) in at least 1 eye at Visits 1 and 2 * Have a conjunctival redness score ≥ 1 according to the Ora Calibra® conjunctival redness for dry eye scale in at least 1 eye at Visits 1 and 2
Exclusion criteria
* Have any clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction, lid margin inflammation or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters * Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1 * Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study * Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months * Have used any cyclosporine-containing drops (such as Restasis®, Cequa®), or lifitegrast ophthalmic solution (Xiidra®) within 60 days of Visit 1 * Have any previous experience using TNF inhibitor ophthalmic solutions, such Tanfanercept Ophthalmic Solution * Be currently taking any topical ophthalmic prescription (including medications for glaucoma) or over-the-counter (OTC) solutions, artificial tears, gels or scrubs, and cannot discontinue these medications for the duration of the trial (excluding medications allowed for the conduct of the study) * Be a woman who is pregnant, nursing or planning a pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Central Corneal Staining Score (CCSS) at Day 57 | Baseline, Day 57 (Week 8) | CCSS was graded using the Ora Calibra® Corneal and Conjunctival Fluorescein Staining Scale. The Ora Calibra® Corneal and Conjunctival Staining Scale ranged 0 = None, 1 = Trace, 2 = Mild, 3 = Moderate, and 4 = Severe; lower score indicated improvement. |
| Change From Baseline in Eye Dryness Score (EDS) Assessed by Visual Analogue Scale at Day 57 | Baseline, Day 57 (Week 8) | Eye dryness score was scored on a Visual Analogue Scale (VAS) that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Inferior Region | Baseline; Weeks 1, 2, 4, and 8 | The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement. |
| Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Temporal Region | Baseline; Weeks 1, 2, 4, and 8 | The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement. |
| Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Nasal Region | Baseline; Weeks 1, 2, 4, and 8 | The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement. |
| Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Corneal Sum | Baseline; Weeks 1, 2, 4, and 8 | The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement. Fluorescein total staining score for corneal regions was derived as the sum of the reported scores for the inferior, superior, and central regions. Total score ranged between 0 to 12, and lower score indicated improvement. |
| Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Conjunctival Sum | Baseline; Weeks 1, 2, 4, and 8 | The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement. Fluorescein total staining score for conjunctival regions was derived the sum of the reported scores for the nasal and temporal regions. Total score ranged between 0 to 8, and lower score indicated improvement. |
| Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Total Staining | Baseline; Weeks 1, 2, 4, and 8 | The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement. Fluorescein total staining score for corneal and conjunctival regions was derived as the sum of the reported scores for the inferior, superior, central, temporal, and nasal regions. Total score ranged between 0 to 20, and lower score indicated improvement. |
| Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Central Region | Baseline; Weeks 1, 2, 4, and 8 | The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of lissamine green staining. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. |
| Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Superior Region | Baseline; Weeks 1, 2, 4, and 8 | The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of lissamine green staining. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. |
| Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Inferior Region | Baseline; Weeks 1, 2, 4, and 8 | The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of lissamine green staining. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. |
| Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Temporal Region | Baseline; Weeks 1, 2, 4, and 8 | The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of lissamine green staining. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. |
| Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Nasal Region | Baseline; Weeks 1, 2, 4, and 8 | The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of lissamine green staining. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. |
| Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Corneal Sum | Baseline; Weeks 1, 2, 4, and 8 | The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of lissamine green staining. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Lissamine Green total staining score for corneal regions was derived as the sum of the reported scores for the inferior, superior, and central regions. Total score ranged between 0 to 12,and lower score indicated improvement. |
| Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Conjunctival Sum | Baseline; Weeks 1, 2, 4, and 8 | The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of lissamine green staining. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Lissamine Green total staining score for conjunctival regions was derived as the sum of the reported scores for the nasal and temporal regions. Total score ranged between 0 to 8, and lower score indicated improvement. |
| Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Total Staining | Baseline; Weeks 1, 2, 4, and 8 | The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of lissamine green staining. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Lissamine Green total staining score for corneal and conjunctival regions was derived as the sum of the reported scores for the inferior, superior, central, nasal, and temporal regions. Total score ranged between 0 to 20, and lower score indicated improvement. |
| Change From Baseline in Conjunctival Redness Score at Weeks 1, 2, 4, and 8 | Baseline; Weeks 1, 2, 4, and 8 | It was evaluated by the Ora Calibra® conjunctival redness scale for dry eye. The score ranged from 0 to 4 (0=none and 4=severe), where lower score indicated improvement. |
| Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Central Region | Baseline; Weeks 1, 2, 4, and 8 | The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement. |
| Change From Baseline in Tear Film Break-up Time at Weeks 1, 2, 4, and 8 | Baseline; Weeks 1, 2, 4, and 8 | Sodium fluorescein solution was instilled into each eye and participants were instructed to blinked several times. The time it took to form micelles from the time that the eye is opened was noted. |
| Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Burning/Stinging | Baseline; Weeks 1, 2, 4, and 8 | Participants rated ocular symptom of burning/stinging by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort). |
| Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Foreign Body Sensation | Baseline; Weeks 1, 2, 4, and 8 | Participants rated ocular symptom of foreign body sensation by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort). |
| Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Itching | Baseline; Weeks 1, 2, 4, and 8 | Participants rated ocular symptom of itching by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort). |
| Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Blurred Vision | Baseline; Weeks 1, 2, 4, and 8 | Participants rated ocular symptom of blurred vision by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort). |
| Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Eye Dryness | Baseline; Weeks 1, 2, 4, and 8 | Participants rated ocular symptom of eye dryness by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort). |
| Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Photophobia | Baseline; Weeks 1, 2, 4, and 8 | Participants rated ocular symptom of photophobia by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort). |
| Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Pain | Baseline; Weeks 1, 2, 4, and 8 | Participants rated ocular symptom of pain by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort). |
| Change From Baseline in Ocular Surface Disease Index (OSDI) at Weeks 1, 2, 4, and 8 | Baseline; Weeks 1, 2, 4, and 8 | OSDI was a simple 12-question survey that rated the severity of the participant's dry eye disease based on the symptoms. Each question response ranged from 0 to 4, where 0 = None of the Time, 1 = Some of the Time, 2 = Half of the Time, 3 = Most of the Time, and 4 = All of the Time. Total OSDI score = (Sum of all answered questions) \* 25/ (number of questions answered); which ranged from 0 to 100, with higher score representing greater disability. |
| Change From Baseline in Ora Calibra® Ocular Discomfort Scale at Weeks 1, 2, 4, and 8 | Baseline; Weeks 1, 2, 4, and 8 | It was assessed by the Ora Calibra® ocular discomfort scale. The score ranged from 0 to 4 (0=none and 4=severe), where lower score indicated improvement. |
| Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Burning Discomfort | Baseline; Weeks 1, 2, 4, and 8 | Ora Calibra® ocular discomfort & 4-symptom questionnaire for dry eye included rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Participants rated the severity of burning at all scheduled visits on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity. |
| Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Dryness Discomfort | Baseline; Weeks 1, 2, 4, and 8 | Ora Calibra® ocular discomfort & 4-symptom questionnaire for dry eye included rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Participants rated the severity of dryness at all scheduled visits on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity. |
| Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Grittiness Discomfort | Baseline; Weeks 1, 2, 4, and 8 | Ora Calibra® ocular discomfort & 4-symptom questionnaire for dry eye included rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Participants rated the severity of grittiness at all scheduled visits on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity. |
| Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Stinging Discomfort | Baseline; Weeks 1, 2, 4, and 8 | Ora Calibra® ocular discomfort & 4-symptom questionnaire for dry eye included rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Participants rated the severity of stinging at all scheduled visits on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity. |
| Ora Calibra® Drop Comfort Assessment at Week 1 | Week 1 | Ora Calibra® drop comfort scale ranged from 0 to 10. A score of 0 indicated comfortable and 10 indicated uncomfortable. Lower score indicated better comfort level. Immediately Upon Instillation, 1 Minute Post Instillation and 2 Minutes Post Instillation at Week 1 |
| Change From Baseline in Schirmer's Test Score at Weeks 2, 4, and 8 | Baseline; Weeks 2, 4, and 8 | The Schirmer test strip was placed in the lower temporal lid margin of each eye. Participants were instructed to close their eyes and after 5 minutes had elapsed, the length of moistened area of schirmer strip was recorded (millimeter \[mm\]) for each eye. |
| Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Superior Region | Baseline; Weeks 1, 2, 4, and 8 | The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement. |
Countries
United States
Participant flow
Recruitment details
Participants who met all the eligibility criteria were enrolled at sites in the United States.
Pre-assignment details
Participants entered the 14-day Placebo Run-in Period prior to randomization and during the 14-day period, assessments were conducted to ascertain eligibility to enter the study. Those who qualified were randomized to receive investigational product (0.25% tanfanercept ophthalmic solution or placebo) in a double-masked fashion for 8 weeks in the Treatment Period.
Participants by arm
| Arm | Count |
|---|---|
| 0.25% Tanfanercept Ophthalmic Solution Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period. | 130 |
| Placebo Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period. | 130 |
| Total | 260 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Treatment Period (8 Weeks) | Administrative reasons | 0 | 1 | 1 |
| Treatment Period (8 Weeks) | Adverse Event | 0 | 5 | 2 |
| Treatment Period (8 Weeks) | Other than specified | 0 | 3 | 1 |
| Treatment Period (8 Weeks) | Protocol Violation | 0 | 0 | 1 |
| Treatment Period (8 Weeks) | Withdrawal by Subject | 0 | 5 | 3 |
Baseline characteristics
| Characteristic | Placebo | Total | 0.25% Tanfanercept Ophthalmic Solution |
|---|---|---|---|
| Age, Continuous | 63.1 years STANDARD_DEVIATION 11.2 | 62.7 years STANDARD_DEVIATION 12.28 | 62.4 years STANDARD_DEVIATION 13.31 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 21 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 121 Participants | 239 Participants | 118 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 13 Participants | 27 Participants | 14 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 27 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 103 Participants | 201 Participants | 98 Participants |
| Sex: Female, Male Female | 90 Participants | 182 Participants | 92 Participants |
| Sex: Female, Male Male | 40 Participants | 78 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 260 | 0 / 130 | 0 / 130 |
| other Total, other adverse events | 7 / 260 | 42 / 130 | 39 / 130 |
| serious Total, serious adverse events | 0 / 260 | 0 / 130 | 1 / 130 |
Outcome results
Primary
Change From Baseline in Central Corneal Staining Score (CCSS) at Day 57
CCSS was graded using the Ora Calibra® Corneal and Conjunctival Fluorescein Staining Scale. The Ora Calibra® Corneal and Conjunctival Staining Scale ranged 0 = None, 1 = Trace, 2 = Mild, 3 = Moderate, and 4 = Severe; lower score indicated improvement.
Time frame: Baseline, Day 57 (Week 8)
Population: ITT population with available data was analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Central Corneal Staining Score (CCSS) at Day 57 | Baseline | 2.40 score on a scale | Standard Deviation 0.497 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Central Corneal Staining Score (CCSS) at Day 57 | Change at Week 8 | -0.82 score on a scale | Standard Deviation 0.812 |
| Placebo | Change From Baseline in Central Corneal Staining Score (CCSS) at Day 57 | Baseline | 2.37 score on a scale | Standard Deviation 0.477 |
| Placebo | Change From Baseline in Central Corneal Staining Score (CCSS) at Day 57 | Change at Week 8 | -0.79 score on a scale | Standard Deviation 0.806 |
Comparison: The Least Square (LS) means, LS mean difference, Standard Errors (SEs), two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the Mixed model repeated measures (MMRM) model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.76495% CI: [-0.214, 0.157]MMRM
Primary
Change From Baseline in Eye Dryness Score (EDS) Assessed by Visual Analogue Scale at Day 57
Eye dryness score was scored on a Visual Analogue Scale (VAS) that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).
Time frame: Baseline, Day 57 (Week 8)
Population: ITT population with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Eye Dryness Score (EDS) Assessed by Visual Analogue Scale at Day 57 | Baseline | 66.1 percentage of dryness | Standard Deviation 22.95 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Eye Dryness Score (EDS) Assessed by Visual Analogue Scale at Day 57 | Change at Week 8 | -16.19 percentage of dryness | Standard Deviation 30.625 |
| Placebo | Change From Baseline in Eye Dryness Score (EDS) Assessed by Visual Analogue Scale at Day 57 | Baseline | 60.8 percentage of dryness | Standard Deviation 25.57 |
| Placebo | Change From Baseline in Eye Dryness Score (EDS) Assessed by Visual Analogue Scale at Day 57 | Change at Week 8 | -19.79 percentage of dryness | Standard Deviation 26.317 |
Comparison: The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.14495% CI: [-1.483, 10.155]MMRM
Secondary
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Central Region
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of lissamine green staining. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement.
Time frame: Baseline; Weeks 1, 2, 4, and 8
Population: ITT population with available data was analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Central Region | Change at Week 1 | 0.01 score on a scale | Standard Deviation 0.663 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Central Region | Change at Week 2 | -0.13 score on a scale | Standard Deviation 0.549 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Central Region | Change at Week 4 | -0.24 score on a scale | Standard Deviation 0.616 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Central Region | Change at Week 8 | -0.29 score on a scale | Standard Deviation 0.602 |
| Placebo | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Central Region | Change at Week 8 | -0.30 score on a scale | Standard Deviation 0.628 |
| Placebo | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Central Region | Change at Week 1 | -0.16 score on a scale | Standard Deviation 0.672 |
| Placebo | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Central Region | Change at Week 4 | -0.30 score on a scale | Standard Deviation 0.624 |
| Placebo | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Central Region | Change at Week 2 | -0.25 score on a scale | Standard Deviation 0.579 |
Comparison: Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.01695% CI: [0.03, 0.292]MMRM
Comparison: Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.09995% CI: [-0.021, 0.242]MMRM
Comparison: Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.49395% CI: [-0.086, 0.179]MMRM
Comparison: Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.98795% CI: [-0.133, 0.135]MMRM
Secondary
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Conjunctival Sum
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of lissamine green staining. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Lissamine Green total staining score for conjunctival regions was derived as the sum of the reported scores for the nasal and temporal regions. Total score ranged between 0 to 8, and lower score indicated improvement.
Time frame: Baseline; Weeks 1, 2, 4, and 8
Population: ITT population with available data was analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Conjunctival Sum | Change at Week 1 | -0.14 score on a scale | Standard Deviation 1.397 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Conjunctival Sum | Change at Week 2 | -0.42 score on a scale | Standard Deviation 1.6 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Conjunctival Sum | Change at Week 4 | -0.42 score on a scale | Standard Deviation 1.348 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Conjunctival Sum | Change at Week 8 | -0.26 score on a scale | Standard Deviation 1.537 |
| Placebo | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Conjunctival Sum | Change at Week 8 | -0.48 score on a scale | Standard Deviation 1.717 |
| Placebo | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Conjunctival Sum | Change at Week 1 | -0.29 score on a scale | Standard Deviation 1.261 |
| Placebo | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Conjunctival Sum | Change at Week 4 | -0.54 score on a scale | Standard Deviation 1.488 |
| Placebo | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Conjunctival Sum | Change at Week 2 | -0.60 score on a scale | Standard Deviation 1.307 |
Comparison: Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.32495% CI: [-0.166, 0.501]MMRM
Comparison: Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.26295% CI: [-0.143, 0.525]MMRM
Comparison: Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.39195% CI: [-0.19, 0.485]MMRM
Comparison: Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.19295% CI: [-0.114, 0.568]MMRM
Secondary
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Corneal Sum
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of lissamine green staining. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Lissamine Green total staining score for corneal regions was derived as the sum of the reported scores for the inferior, superior, and central regions. Total score ranged between 0 to 12,and lower score indicated improvement.
Time frame: Baseline; Weeks 1, 2, 4, and 8
Population: ITT population with available data was analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Corneal Sum | Change at Week 1 | -0.17 score on a scale | Standard Deviation 1.622 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Corneal Sum | Change at Week 2 | -0.39 score on a scale | Standard Deviation 1.395 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Corneal Sum | Change at Week 4 | -0.74 score on a scale | Standard Deviation 1.334 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Corneal Sum | Change at Week 8 | -0.69 score on a scale | Standard Deviation 1.344 |
| Placebo | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Corneal Sum | Change at Week 8 | -0.82 score on a scale | Standard Deviation 1.691 |
| Placebo | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Corneal Sum | Change at Week 1 | -0.42 score on a scale | Standard Deviation 1.526 |
| Placebo | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Corneal Sum | Change at Week 4 | -0.79 score on a scale | Standard Deviation 1.516 |
| Placebo | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Corneal Sum | Change at Week 2 | -0.75 score on a scale | Standard Deviation 1.445 |
Comparison: Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.13195% CI: [-0.077, 0.591]MMRM
Comparison: Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.0495% CI: [0.016, 0.685]MMRM
Comparison: Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.76795% CI: [-0.287, 0.389]MMRM
Comparison: Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.4195% CI: [-0.198, 0.485]MMRM
Secondary
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Inferior Region
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of lissamine green staining. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement.
Time frame: Baseline; Weeks 1, 2, 4, and 8
Population: ITT population with available data was analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Inferior Region | Change at Week 1 | -0.07 score on a scale | Standard Deviation 0.789 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Inferior Region | Change at Week 2 | -0.06 score on a scale | Standard Deviation 0.766 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Inferior Region | Change at Week 4 | -0.25 score on a scale | Standard Deviation 0.606 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Inferior Region | Change at Week 8 | -0.23 score on a scale | Standard Deviation 0.7 |
| Placebo | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Inferior Region | Change at Week 8 | -0.33 score on a scale | Standard Deviation 0.889 |
| Placebo | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Inferior Region | Change at Week 1 | -0.14 score on a scale | Standard Deviation 0.797 |
| Placebo | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Inferior Region | Change at Week 4 | -0.27 score on a scale | Standard Deviation 0.802 |
| Placebo | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Inferior Region | Change at Week 2 | -0.33 score on a scale | Standard Deviation 0.741 |
Comparison: Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.52795% CI: [-0.116, 0.226]MMRM
Comparison: Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.00595% CI: [0.077, 0.418]MMRM
Comparison: Wek 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errorsp-value: 0.9295% CI: [-0.164, 0.181]MMRM
Comparison: Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.28695% CI: [-0.08, 0.269]MMRM
Secondary
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Nasal Region
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of lissamine green staining. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement.
Time frame: Baseline; Weeks 1, 2, 4, and 8
Population: ITT population with available data was analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Nasal Region | Change at Week 1 | -0.13 score on a scale | Standard Deviation 0.735 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Nasal Region | Change at Week 2 | -0.25 score on a scale | Standard Deviation 0.962 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Nasal Region | Change at Week 4 | -0.19 score on a scale | Standard Deviation 0.775 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Nasal Region | Change at Week 8 | -0.11 score on a scale | Standard Deviation 0.926 |
| Placebo | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Nasal Region | Change at Week 8 | -0.31 score on a scale | Standard Deviation 1.044 |
| Placebo | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Nasal Region | Change at Week 1 | -0.10 score on a scale | Standard Deviation 0.781 |
| Placebo | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Nasal Region | Change at Week 4 | -0.24 score on a scale | Standard Deviation 0.896 |
| Placebo | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Nasal Region | Change at Week 2 | -0.35 score on a scale | Standard Deviation 0.699 |
Comparison: Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.88495% CI: [-0.206, 0.178]MMRM
Comparison: Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.30395% CI: [-0.091, 0.293]MMRM
Comparison: Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.55495% CI: [-0.135, 0.253]MMRM
Comparison: Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.05195% CI: [-0.001, 0.391]MMRM
Secondary
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Superior Region
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of lissamine green staining. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement.
Time frame: Baseline; Weeks 1, 2, 4, and 8
Population: ITT population with available data was analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Superior Region | Change at Week 1 | -0.11 score on a scale | Standard Deviation 0.8 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Superior Region | Change at Week 2 | -0.20 score on a scale | Standard Deviation 0.721 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Superior Region | Change at Week 4 | -0.25 score on a scale | Standard Deviation 0.674 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Superior Region | Change at Week 8 | -0.18 score on a scale | Standard Deviation 0.592 |
| Placebo | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Superior Region | Change at Week 8 | -0.19 score on a scale | Standard Deviation 0.656 |
| Placebo | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Superior Region | Change at Week 1 | -0.12 score on a scale | Standard Deviation 0.523 |
| Placebo | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Superior Region | Change at Week 4 | -0.22 score on a scale | Standard Deviation 0.549 |
| Placebo | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Superior Region | Change at Week 2 | -0.17 score on a scale | Standard Deviation 0.576 |
Comparison: Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.65595% CI: [-0.109, 0.173]MMRM
Comparison: Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.82695% CI: [-0.157, 0.125]MMRM
Comparison: Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.86195% CI: [-0.155, 0.13]MMRM
Comparison: Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.55695% CI: [-0.101, 0.187]MMRM
Secondary
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Temporal Region
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of lissamine green staining. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement.
Time frame: Baseline; Weeks 1, 2, 4, and 8
Population: ITT population with available data was analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Temporal Region | Change at Week 1 | -0.02 score on a scale | Standard Deviation 0.875 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Temporal Region | Change at Week 2 | -0.17 score on a scale | Standard Deviation 0.924 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Temporal Region | Change at Week 4 | -0.23 score on a scale | Standard Deviation 0.822 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Temporal Region | Change at Week 8 | -0.15 score on a scale | Standard Deviation 0.817 |
| Placebo | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Temporal Region | Change at Week 8 | -0.17 score on a scale | Standard Deviation 0.896 |
| Placebo | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Temporal Region | Change at Week 1 | -0.18 score on a scale | Standard Deviation 0.809 |
| Placebo | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Temporal Region | Change at Week 4 | -0.31 score on a scale | Standard Deviation 0.79 |
| Placebo | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Temporal Region | Change at Week 2 | -0.25 score on a scale | Standard Deviation 0.817 |
Comparison: Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.07195% CI: [-0.015, 0.369]MMRM
Comparison: Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.38495% CI: [-0.107, 0.278]MMRM
Comparison: Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.39195% CI: [-0.109, 0.28]MMRM
Comparison: Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.80295% CI: [-0.171, 0.222]MMRM
Secondary
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Total Staining
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of lissamine green staining. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Lissamine Green total staining score for corneal and conjunctival regions was derived as the sum of the reported scores for the inferior, superior, central, nasal, and temporal regions. Total score ranged between 0 to 20, and lower score indicated improvement.
Time frame: Baseline; Weeks 1, 2, 4, and 8
Population: ITT population with available data was analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Total Staining | Change at Week 1 | -0.32 score on a scale | Standard Deviation 2.634 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Total Staining | Change at Week 2 | -0.81 score on a scale | Standard Deviation 2.618 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Total Staining | Change at Week 4 | -1.16 score on a scale | Standard Deviation 2.262 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Total Staining | Change at Week 8 | -0.95 score on a scale | Standard Deviation 2.364 |
| Placebo | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Total Staining | Change at Week 8 | -1.29 score on a scale | Standard Deviation 2.912 |
| Placebo | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Total Staining | Change at Week 1 | -0.71 score on a scale | Standard Deviation 2.252 |
| Placebo | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Total Staining | Change at Week 4 | -1.33 score on a scale | Standard Deviation 2.507 |
| Placebo | Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Total Staining | Change at Week 2 | -1.35 score on a scale | Standard Deviation 2.277 |
Comparison: Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.1495% CI: [-0.141, 0.999]MMRM
Comparison: Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.06195% CI: [-0.025, 1.117]MMRM
Comparison: Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.4995% CI: [-0.374, 0.78]MMRM
Comparison: Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.21295% CI: [-0.212, 0.953]MMRM
Secondary
Change From Baseline in Conjunctival Redness Score at Weeks 1, 2, 4, and 8
It was evaluated by the Ora Calibra® conjunctival redness scale for dry eye. The score ranged from 0 to 4 (0=none and 4=severe), where lower score indicated improvement.
Time frame: Baseline; Weeks 1, 2, 4, and 8
Population: ITT population with available data was analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Conjunctival Redness Score at Weeks 1, 2, 4, and 8 | Change at Week 1 | -0.10 score on a scale | Standard Deviation 0.45 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Conjunctival Redness Score at Weeks 1, 2, 4, and 8 | Change at Week 2 | -0.14 score on a scale | Standard Deviation 0.435 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Conjunctival Redness Score at Weeks 1, 2, 4, and 8 | Change at Week 4 | -0.13 score on a scale | Standard Deviation 0.577 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Conjunctival Redness Score at Weeks 1, 2, 4, and 8 | Change at Week 8 | -0.09 score on a scale | Standard Deviation 0.648 |
| Placebo | Change From Baseline in Conjunctival Redness Score at Weeks 1, 2, 4, and 8 | Change at Week 8 | -0.32 score on a scale | Standard Deviation 0.544 |
| Placebo | Change From Baseline in Conjunctival Redness Score at Weeks 1, 2, 4, and 8 | Change at Week 1 | -0.08 score on a scale | Standard Deviation 0.519 |
| Placebo | Change From Baseline in Conjunctival Redness Score at Weeks 1, 2, 4, and 8 | Change at Week 4 | -0.22 score on a scale | Standard Deviation 0.534 |
| Placebo | Change From Baseline in Conjunctival Redness Score at Weeks 1, 2, 4, and 8 | Change at Week 2 | -0.19 score on a scale | Standard Deviation 0.456 |
Comparison: Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.78495% CI: [-0.134, 0.101]MMRM
Comparison: Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.32495% CI: [-0.058, 0.176]MMRM
Comparison: Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.1395% CI: [-0.027, 0.21]MMRM
Comparison: Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 095% CI: [0.11, 0.35]MMRM
Secondary
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Central Region
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement.
Time frame: Baseline; Weeks 1, 2, 4, and 8
Population: ITT population with available data was analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Central Region | Change at Week 1 | -0.43 score on a scale | Standard Deviation 0.649 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Central Region | Change at Week 2 | -0.45 score on a scale | Standard Deviation 0.814 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Central Region | Change at Week 4 | -0.57 score on a scale | Standard Deviation 0.788 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Central Region | Change at Week 8 | -0.82 score on a scale | Standard Deviation 0.812 |
| Placebo | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Central Region | Change at Week 8 | -0.79 score on a scale | Standard Deviation 0.806 |
| Placebo | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Central Region | Change at Week 1 | -0.59 score on a scale | Standard Deviation 0.667 |
| Placebo | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Central Region | Change at Week 4 | -0.64 score on a scale | Standard Deviation 0.861 |
| Placebo | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Central Region | Change at Week 2 | -0.61 score on a scale | Standard Deviation 0.723 |
Comparison: Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.05695% CI: [-0.005, 0.363]MMRM
Comparison: Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.06495% CI: [-0.01, 0.359]MMRM
Comparison: Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.32895% CI: [-0.093, 0.279]MMRM
Comparison: Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.83795% CI: [-0.208, 0.168]MMRM
Secondary
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Conjunctival Sum
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement. Fluorescein total staining score for conjunctival regions was derived the sum of the reported scores for the nasal and temporal regions. Total score ranged between 0 to 8, and lower score indicated improvement.
Time frame: Baseline; Weeks 1, 2, 4, and 8
Population: ITT population with available data was analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Conjunctival Sum | Change at Week 1 | -0.28 score on a scale | Standard Deviation 1.219 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Conjunctival Sum | Change at Week 2 | -0.31 score on a scale | Standard Deviation 1.582 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Conjunctival Sum | Change at Week 4 | -0.36 score on a scale | Standard Deviation 1.463 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Conjunctival Sum | Change at Week 8 | -0.39 score on a scale | Standard Deviation 1.427 |
| Placebo | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Conjunctival Sum | Change at Week 8 | -0.74 score on a scale | Standard Deviation 1.51 |
| Placebo | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Conjunctival Sum | Change at Week 1 | -0.29 score on a scale | Standard Deviation 1.184 |
| Placebo | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Conjunctival Sum | Change at Week 4 | -0.54 score on a scale | Standard Deviation 1.352 |
| Placebo | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Conjunctival Sum | Change at Week 2 | -0.42 score on a scale | Standard Deviation 1.371 |
Comparison: Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.82495% CI: [-0.273, 0.343]MMRM
Comparison: Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.43795% CI: [-0.186, 0.431]MMRM
Comparison: Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.19395% CI: [-0.105, 0.519]MMRM
Comparison: Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.02495% CI: [0.048, 0.679]MMRM
Secondary
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Corneal Sum
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement. Fluorescein total staining score for corneal regions was derived as the sum of the reported scores for the inferior, superior, and central regions. Total score ranged between 0 to 12, and lower score indicated improvement.
Time frame: Baseline; Weeks 1, 2, 4, and 8
Population: ITT population with available data was analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Corneal Sum | Change at Week 1 | -0.78 score on a scale | Standard Deviation 1.37 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Corneal Sum | Change at Week 2 | -0.76 score on a scale | Standard Deviation 1.929 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Corneal Sum | Change at Week 4 | -0.94 score on a scale | Standard Deviation 1.877 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Corneal Sum | Change at Week 8 | -1.52 score on a scale | Standard Deviation 1.904 |
| Placebo | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Corneal Sum | Change at Week 8 | -1.39 score on a scale | Standard Deviation 2.049 |
| Placebo | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Corneal Sum | Change at Week 1 | -0.91 score on a scale | Standard Deviation 1.585 |
| Placebo | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Corneal Sum | Change at Week 4 | -1.04 score on a scale | Standard Deviation 1.976 |
| Placebo | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Corneal Sum | Change at Week 2 | -1.06 score on a scale | Standard Deviation 1.75 |
Comparison: Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.29395% CI: [-0.196, 0.647]MMRM
Comparison: Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.09495% CI: [-0.062, 0.783]MMRM
Comparison: Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.40495% CI: [-0.245, 0.608]MMRM
Comparison: Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.80695% CI: [-0.485, 0.377]MMRM
Secondary
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Inferior Region
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement.
Time frame: Baseline; Weeks 1, 2, 4, and 8
Population: ITT population with available data was analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Inferior Region | Change at Week 1 | -0.14 score on a scale | Standard Deviation 0.611 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Inferior Region | Change at Week 2 | -0.10 score on a scale | Standard Deviation 0.732 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Inferior Region | Change at Week 4 | -0.12 score on a scale | Standard Deviation 0.756 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Inferior Region | Change at Week 8 | -0.33 score on a scale | Standard Deviation 0.708 |
| Placebo | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Inferior Region | Change at Week 8 | -0.27 score on a scale | Standard Deviation 0.892 |
| Placebo | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Inferior Region | Change at Week 1 | -0.13 score on a scale | Standard Deviation 0.684 |
| Placebo | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Inferior Region | Change at Week 4 | -0.15 score on a scale | Standard Deviation 0.77 |
| Placebo | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Inferior Region | Change at Week 2 | -0.24 score on a scale | Standard Deviation 0.729 |
Comparison: Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.76595% CI: [-0.141, 0.192]MMRM
Comparison: Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.05395% CI: [-0.002, 0.331]MMRM
Comparison: Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.55295% CI: [-0.117, 0.219]MMRM
Comparison: Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.59395% CI: [-0.216, 0.124]MMRM
Secondary
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Nasal Region
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement.
Time frame: Baseline; Weeks 1, 2, 4, and 8
Population: ITT population with available data was analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Nasal Region | Change at Week 1 | -0.12 score on a scale | Standard Deviation 0.703 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Nasal Region | Change at Week 4 | -0.19 score on a scale | Standard Deviation 0.817 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Nasal Region | Change at Week 2 | -0.17 score on a scale | Standard Deviation 0.86 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Nasal Region | Change at Week 8 | -0.19 score on a scale | Standard Deviation 0.829 |
| Placebo | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Nasal Region | Change at Week 2 | -0.23 score on a scale | Standard Deviation 0.797 |
| Placebo | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Nasal Region | Change at Week 1 | -0.16 score on a scale | Standard Deviation 0.7 |
| Placebo | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Nasal Region | Change at Week 8 | -0.33 score on a scale | Standard Deviation 0.879 |
| Placebo | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Nasal Region | Change at Week 4 | -0.27 score on a scale | Standard Deviation 0.822 |
Comparison: Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.60495% CI: [-0.131, 0.224]MMRM
Comparison: Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.51995% CI: [-0.119, 0.236]MMRM
Comparison: Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.29995% CI: [-0.085, 0.275]MMRM
Comparison: Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.12495% CI: [-0.039, 0.324]MMRM
Secondary
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Superior Region
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement.
Time frame: Baseline; Weeks 1, 2, 4, and 8
Population: ITT population with available data was analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Superior Region | Change at Week 1 | -0.21 score on a scale | Standard Deviation 0.572 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Superior Region | Change at Week 2 | -0.22 score on a scale | Standard Deviation 0.805 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Superior Region | Change at Week 4 | -0.25 score on a scale | Standard Deviation 0.731 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Superior Region | Change at Week 8 | -0.37 score on a scale | Standard Deviation 0.747 |
| Placebo | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Superior Region | Change at Week 8 | -0.33 score on a scale | Standard Deviation 0.729 |
| Placebo | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Superior Region | Change at Week 1 | -0.20 score on a scale | Standard Deviation 0.639 |
| Placebo | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Superior Region | Change at Week 4 | -0.25 score on a scale | Standard Deviation 0.753 |
| Placebo | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Superior Region | Change at Week 2 | -0.21 score on a scale | Standard Deviation 0.705 |
Comparison: Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.68695% CI: [-0.123, 0.187]MMRM
Comparison: Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.6895% CI: [-0.123, 0.188]MMRM
Comparison: Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.52995% CI: [-0.107, 0.207]MMRM
Comparison: Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.74595% CI: [-0.132, 0.185]MMRM
Secondary
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Temporal Region
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement.
Time frame: Baseline; Weeks 1, 2, 4, and 8
Population: ITT population with available data was analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Temporal Region | Change at Week 1 | -0.16 score on a scale | Standard Deviation 0.742 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Temporal Region | Change at Week 2 | -0.14 score on a scale | Standard Deviation 0.87 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Temporal Region | Change at Week 4 | -0.17 score on a scale | Standard Deviation 0.875 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Temporal Region | Change at Week 8 | -0.20 score on a scale | Standard Deviation 0.746 |
| Placebo | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Temporal Region | Change at Week 8 | -0.40 score on a scale | Standard Deviation 0.827 |
| Placebo | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Temporal Region | Change at Week 1 | -0.13 score on a scale | Standard Deviation 0.749 |
| Placebo | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Temporal Region | Change at Week 4 | -0.27 score on a scale | Standard Deviation 0.756 |
| Placebo | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Temporal Region | Change at Week 2 | -0.19 score on a scale | Standard Deviation 0.785 |
Comparison: Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.88495% CI: [-0.183, 0.158]MMRM
Comparison: Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.47495% CI: [-0.109, 0.233]MMRM
Comparison: Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.20295% CI: [-0.06, 0.285]MMRM
Comparison: Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.01395% CI: [0.047, 0.396]MMRM
Secondary
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Total Staining
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement. Fluorescein total staining score for corneal and conjunctival regions was derived as the sum of the reported scores for the inferior, superior, central, temporal, and nasal regions. Total score ranged between 0 to 20, and lower score indicated improvement.
Time frame: Baseline; Weeks 1, 2, 4, and 8
Population: ITT population with available data was analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Total Staining | Change at Week 1 | -1.07 score on a scale | Standard Deviation 2.104 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Total Staining | Change at Week 2 | -1.07 score on a scale | Standard Deviation 3.125 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Total Staining | Change at Week 4 | -1.30 score on a scale | Standard Deviation 2.974 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Total Staining | Change at Week 8 | -1.92 score on a scale | Standard Deviation 2.931 |
| Placebo | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Total Staining | Change at Week 8 | -2.12 score on a scale | Standard Deviation 3.234 |
| Placebo | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Total Staining | Change at Week 1 | -1.20 score on a scale | Standard Deviation 2.395 |
| Placebo | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Total Staining | Change at Week 4 | -1.58 score on a scale | Standard Deviation 2.956 |
| Placebo | Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Total Staining | Change at Week 2 | -1.48 score on a scale | Standard Deviation 2.672 |
Comparison: Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.4395% CI: [-0.386, 0.907]MMRM
Comparison: Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.14395% CI: [-0.164, 1.132]MMRM
Comparison: Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.24595% CI: [-0.267, 1.042]MMRM
Comparison: Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.35995% CI: [-0.352, 0.97]MMRM
Secondary
Change From Baseline in Ocular Surface Disease Index (OSDI) at Weeks 1, 2, 4, and 8
OSDI was a simple 12-question survey that rated the severity of the participant's dry eye disease based on the symptoms. Each question response ranged from 0 to 4, where 0 = None of the Time, 1 = Some of the Time, 2 = Half of the Time, 3 = Most of the Time, and 4 = All of the Time. Total OSDI score = (Sum of all answered questions) \* 25/ (number of questions answered); which ranged from 0 to 100, with higher score representing greater disability.
Time frame: Baseline; Weeks 1, 2, 4, and 8
Population: ITT population with available data was analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Ocular Surface Disease Index (OSDI) at Weeks 1, 2, 4, and 8 | Change at Week 1 | -3.13 score on a scale | Standard Deviation 13.229 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Ocular Surface Disease Index (OSDI) at Weeks 1, 2, 4, and 8 | Change at Week 2 | -4.85 score on a scale | Standard Deviation 16.092 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Ocular Surface Disease Index (OSDI) at Weeks 1, 2, 4, and 8 | Change at Week 4 | -4.54 score on a scale | Standard Deviation 18.002 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Ocular Surface Disease Index (OSDI) at Weeks 1, 2, 4, and 8 | Change at Week 8 | -6.74 score on a scale | Standard Deviation 18.702 |
| Placebo | Change From Baseline in Ocular Surface Disease Index (OSDI) at Weeks 1, 2, 4, and 8 | Change at Week 8 | -9.99 score on a scale | Standard Deviation 14.215 |
| Placebo | Change From Baseline in Ocular Surface Disease Index (OSDI) at Weeks 1, 2, 4, and 8 | Change at Week 1 | -5.65 score on a scale | Standard Deviation 14.785 |
| Placebo | Change From Baseline in Ocular Surface Disease Index (OSDI) at Weeks 1, 2, 4, and 8 | Change at Week 4 | -8.16 score on a scale | Standard Deviation 15.17 |
| Placebo | Change From Baseline in Ocular Surface Disease Index (OSDI) at Weeks 1, 2, 4, and 8 | Change at Week 2 | -6.23 score on a scale | Standard Deviation 14.617 |
Comparison: Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errorsp-value: 0.04195% CI: [0.154, 6.994]MMRM
Comparison: Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errorsp-value: 0.12295% CI: [-0.723, 6.118]MMRM
Comparison: Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errorsp-value: 0.00995% CI: [1.146, 8.056]MMRM
Comparison: Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errorsp-value: 0.02495% CI: [0.544, 7.536]MMRM
Secondary
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Burning Discomfort
Ora Calibra® ocular discomfort & 4-symptom questionnaire for dry eye included rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Participants rated the severity of burning at all scheduled visits on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity.
Time frame: Baseline; Weeks 1, 2, 4, and 8
Population: ITT population with available data will be analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Burning Discomfort | Change at Week 1 | -0.44 score on a scale | Standard Deviation 1.304 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Burning Discomfort | Change at Week 2 | -0.42 score on a scale | Standard Deviation 1.277 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Burning Discomfort | Change at Week 4 | -0.56 score on a scale | Standard Deviation 1.477 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Burning Discomfort | Change at Week 8 | -0.55 score on a scale | Standard Deviation 1.511 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Burning Discomfort | Change at Week 8 | -0.55 score on a scale | Standard Deviation 1.304 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Burning Discomfort | Change at Week 1 | -0.23 score on a scale | Standard Deviation 1.409 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Burning Discomfort | Change at Week 4 | -0.35 score on a scale | Standard Deviation 1.238 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Burning Discomfort | Change at Week 2 | -0.29 score on a scale | Standard Deviation 1.338 |
Comparison: Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errorsp-value: 0.96995% CI: [-0.3, 0.288]MMRM
Comparison: Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errorsp-value: 0.50495% CI: [-0.194, 0.394]MMRM
Comparison: Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errorsp-value: 0.91595% CI: [-0.281, 0.314]MMRM
Comparison: Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errorsp-value: 0.19595% CI: [-0.102, 0.499]MMRM
Secondary
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Dryness Discomfort
Ora Calibra® ocular discomfort & 4-symptom questionnaire for dry eye included rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Participants rated the severity of dryness at all scheduled visits on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity.
Time frame: Baseline; Weeks 1, 2, 4, and 8
Population: ITT population with available data will be analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Dryness Discomfort | Change at Week 1 | -0.34 score on a scale | Standard Deviation 1.048 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Dryness Discomfort | Change at Week 2 | -0.43 score on a scale | Standard Deviation 1.266 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Dryness Discomfort | Change at Week 4 | -0.60 score on a scale | Standard Deviation 1.334 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Dryness Discomfort | Change at Week 8 | -0.66 score on a scale | Standard Deviation 1.446 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Dryness Discomfort | Change at Week 8 | -0.74 score on a scale | Standard Deviation 1.262 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Dryness Discomfort | Change at Week 1 | -0.34 score on a scale | Standard Deviation 1.234 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Dryness Discomfort | Change at Week 4 | -0.44 score on a scale | Standard Deviation 1.314 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Dryness Discomfort | Change at Week 2 | -0.43 score on a scale | Standard Deviation 1.268 |
Comparison: Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errorsp-value: 0.28795% CI: [-0.133, 0.449]MMRM
Comparison: Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errorsp-value: 0.2695% CI: [-0.124, 0.458]MMRM
Comparison: Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errorsp-value: 0.98795% CI: [-0.296, 0.291]MMRM
Comparison: Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errorsp-value: 0.14395% CI: [-0.075, 0.519]MMRM
Secondary
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Grittiness Discomfort
Ora Calibra® ocular discomfort & 4-symptom questionnaire for dry eye included rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Participants rated the severity of grittiness at all scheduled visits on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity.
Time frame: Baseline; Weeks 1, 2, 4, and 8
Population: ITT population with available data will be analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Grittiness Discomfort | Change at Week 1 | -0.26 score on a scale | Standard Deviation 1.231 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Grittiness Discomfort | Change at Week 2 | -0.45 score on a scale | Standard Deviation 1.478 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Grittiness Discomfort | Change at Week 4 | -0.48 score on a scale | Standard Deviation 1.421 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Grittiness Discomfort | Change at Week 8 | -0.58 score on a scale | Standard Deviation 1.441 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Grittiness Discomfort | Change at Week 8 | -0.59 score on a scale | Standard Deviation 1.302 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Grittiness Discomfort | Change at Week 1 | -0.29 score on a scale | Standard Deviation 1.278 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Grittiness Discomfort | Change at Week 4 | -0.38 score on a scale | Standard Deviation 1.214 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Grittiness Discomfort | Change at Week 2 | -0.56 score on a scale | Standard Deviation 1.293 |
Comparison: Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: -0.19895% CI: [-0.102, 0.49]MMRM
Comparison: Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.07695% CI: [-0.028, 0.564]MMRM
Comparison: Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.65695% CI: [-0.231, 0.367]MMRM
Comparison: Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.32495% CI: [-0.15, 0.454]MMRM
Secondary
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Stinging Discomfort
Ora Calibra® ocular discomfort & 4-symptom questionnaire for dry eye included rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Participants rated the severity of stinging at all scheduled visits on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity.
Time frame: Baseline; Weeks 1, 2, 4, and 8
Population: ITT population with available data will be analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Stinging Discomfort | Change at Week 1 | -0.30 score on a scale | Standard Deviation 1.193 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Stinging Discomfort | Change at Week 2 | -0.34 score on a scale | Standard Deviation 1.191 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Stinging Discomfort | Change at Week 4 | -0.50 score on a scale | Standard Deviation 1.362 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Stinging Discomfort | Change at Week 8 | -0.50 score on a scale | Standard Deviation 1.371 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Stinging Discomfort | Change at Week 8 | -0.61 score on a scale | Standard Deviation 1.254 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Stinging Discomfort | Change at Week 1 | -0.31 score on a scale | Standard Deviation 1.365 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Stinging Discomfort | Change at Week 4 | -0.50 score on a scale | Standard Deviation 1.37 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Stinging Discomfort | Change at Week 2 | -0.52 score on a scale | Standard Deviation 1.25 |
Comparison: Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errorsp-value: 0.47795% CI: [-0.182, 0.39]MMRM
Comparison: Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errorsp-value: 0.03395% CI: [0.026, 0.598]MMRM
Comparison: Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errorsp-value: 0.37495% CI: [-0.158, 0.42]MMRM
Comparison: Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errorsp-value: 0.11495% CI: [-0.056, 0.529]MMRM
Secondary
Change From Baseline in Ora Calibra® Ocular Discomfort Scale at Weeks 1, 2, 4, and 8
It was assessed by the Ora Calibra® ocular discomfort scale. The score ranged from 0 to 4 (0=none and 4=severe), where lower score indicated improvement.
Time frame: Baseline; Weeks 1, 2, 4, and 8
Population: ITT population with available data was analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort Scale at Weeks 1, 2, 4, and 8 | Change at Week 1 | -0.22 score on a scale | Standard Deviation 1.177 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort Scale at Weeks 1, 2, 4, and 8 | Change at Week 2 | -0.34 score on a scale | Standard Deviation 1.172 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort Scale at Weeks 1, 2, 4, and 8 | Change at Week 4 | -0.48 score on a scale | Standard Deviation 1.294 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort Scale at Weeks 1, 2, 4, and 8 | Change at Week 8 | -0.53 score on a scale | Standard Deviation 1.261 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort Scale at Weeks 1, 2, 4, and 8 | Change at Week 8 | -0.71 score on a scale | Standard Deviation 1.083 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort Scale at Weeks 1, 2, 4, and 8 | Change at Week 1 | -0.31 score on a scale | Standard Deviation 1.084 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort Scale at Weeks 1, 2, 4, and 8 | Change at Week 4 | -0.39 score on a scale | Standard Deviation 1.11 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort Scale at Weeks 1, 2, 4, and 8 | Change at Week 2 | -0.41 score on a scale | Standard Deviation 1.06 |
Comparison: Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errorsp-value: 0.28295% CI: [-0.115, 0.394]MMRM
Comparison: Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errorsp-value: 0.35395% CI: [-0.134, 0.375]MMRM
Comparison: Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errorsp-value: 0.76495% CI: [-0.297, 0.218]MMRM
Comparison: Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errorsp-value: 0.10495% CI: [-0.044, 0.476]MMRM
Secondary
Change From Baseline in Schirmer's Test Score at Weeks 2, 4, and 8
The Schirmer test strip was placed in the lower temporal lid margin of each eye. Participants were instructed to close their eyes and after 5 minutes had elapsed, the length of moistened area of schirmer strip was recorded (millimeter \[mm\]) for each eye.
Time frame: Baseline; Weeks 2, 4, and 8
Population: ITT population with available data was analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Schirmer's Test Score at Weeks 2, 4, and 8 | Change at Week 2 | 0.69 mm | Standard Deviation 5.155 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Schirmer's Test Score at Weeks 2, 4, and 8 | Change at Week 4 | 1.24 mm | Standard Deviation 5.858 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Schirmer's Test Score at Weeks 2, 4, and 8 | Change at Week 8 | 2.45 mm | Standard Deviation 5.913 |
| Placebo | Change From Baseline in Schirmer's Test Score at Weeks 2, 4, and 8 | Change at Week 2 | 0.31 mm | Standard Deviation 4.361 |
| Placebo | Change From Baseline in Schirmer's Test Score at Weeks 2, 4, and 8 | Change at Week 4 | 0.56 mm | Standard Deviation 4.972 |
| Placebo | Change From Baseline in Schirmer's Test Score at Weeks 2, 4, and 8 | Change at Week 8 | 0.51 mm | Standard Deviation 4.257 |
Comparison: Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.53295% CI: [-0.834, 1.613]MMRM
Comparison: Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.25295% CI: [-0.515, 1.959]MMRM
Comparison: Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.00295% CI: [0.732, 3.231]MMRM
Secondary
Change From Baseline in Tear Film Break-up Time at Weeks 1, 2, 4, and 8
Sodium fluorescein solution was instilled into each eye and participants were instructed to blinked several times. The time it took to form micelles from the time that the eye is opened was noted.
Time frame: Baseline; Weeks 1, 2, 4, and 8
Population: ITT population with available data was analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Tear Film Break-up Time at Weeks 1, 2, 4, and 8 | Change at Week 1 | 0.45 seconds | Standard Deviation 1.643 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Tear Film Break-up Time at Weeks 1, 2, 4, and 8 | Change at Week 2 | 0.17 seconds | Standard Deviation 1.168 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Tear Film Break-up Time at Weeks 1, 2, 4, and 8 | Change at Week 4 | 0.16 seconds | Standard Deviation 1.064 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Tear Film Break-up Time at Weeks 1, 2, 4, and 8 | Change at Week 8 | 0.52 seconds | Standard Deviation 1.548 |
| Placebo | Change From Baseline in Tear Film Break-up Time at Weeks 1, 2, 4, and 8 | Change at Week 8 | 0.48 seconds | Standard Deviation 1.226 |
| Placebo | Change From Baseline in Tear Film Break-up Time at Weeks 1, 2, 4, and 8 | Change at Week 1 | 0.55 seconds | Standard Deviation 1.513 |
| Placebo | Change From Baseline in Tear Film Break-up Time at Weeks 1, 2, 4, and 8 | Change at Week 4 | 0.57 seconds | Standard Deviation 1.6 |
| Placebo | Change From Baseline in Tear Film Break-up Time at Weeks 1, 2, 4, and 8 | Change at Week 2 | 0.42 seconds | Standard Deviation 1.171 |
Comparison: Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.72395% CI: [-0.386, 0.268]MMRM
Comparison: Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.25495% CI: [-0.519, 0.137]MMRM
Comparison: Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.03495% CI: [-0.69, -0.028]MMRM
Comparison: Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.6495% CI: [-0.255, 0.414]MMRM
Secondary
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Blurred Vision
Participants rated ocular symptom of blurred vision by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).
Time frame: Baseline; Weeks 1, 2, 4, and 8
Population: ITT population with available data was analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Blurred Vision | Change at Week 1 | -5.95 percentage of blurred vision | Standard Deviation 20.483 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Blurred Vision | Change at Week 2 | -8.94 percentage of blurred vision | Standard Deviation 21.564 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Blurred Vision | Change at Week 4 | -9.50 percentage of blurred vision | Standard Deviation 25.051 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Blurred Vision | Change at Week 8 | -9.24 percentage of blurred vision | Standard Deviation 26.069 |
| Placebo | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Blurred Vision | Change at Week 8 | -9.46 percentage of blurred vision | Standard Deviation 23.783 |
| Placebo | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Blurred Vision | Change at Week 1 | -7.53 percentage of blurred vision | Standard Deviation 18.674 |
| Placebo | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Blurred Vision | Change at Week 4 | -9.49 percentage of blurred vision | Standard Deviation 22.681 |
| Placebo | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Blurred Vision | Change at Week 2 | -8.61 percentage of blurred vision | Standard Deviation 22.511 |
Comparison: Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errorsp-value: 0.1195% CI: [-0.958, 9.425]MMRM
Comparison: Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errorsp-value: 0.31595% CI: [-2.535, 7.855]MMRM
Comparison: Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errorsp-value: 0.31895% CI: [-2.582, 7.928]MMRM
Comparison: Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errorsp-value: 0.30395% CI: [-2.525, 8.111]MMRM
Secondary
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Burning/Stinging
Participants rated ocular symptom of burning/stinging by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).
Time frame: Baseline; Weeks 1, 2, 4, and 8
Population: ITT population with available data was analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Burning/Stinging | Change at Week 1 | -7.49 percentage of burining/stinging | Standard Deviation 27.712 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Burning/Stinging | Change at Week 2 | -8.74 percentage of burining/stinging | Standard Deviation 26.961 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Burning/Stinging | Change at Week 4 | -11.84 percentage of burining/stinging | Standard Deviation 29.437 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Burning/Stinging | Change at Week 8 | -12.17 percentage of burining/stinging | Standard Deviation 28.441 |
| Placebo | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Burning/Stinging | Change at Week 8 | -11.82 percentage of burining/stinging | Standard Deviation 22.174 |
| Placebo | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Burning/Stinging | Change at Week 1 | -5.43 percentage of burining/stinging | Standard Deviation 21.63 |
| Placebo | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Burning/Stinging | Change at Week 4 | -9.04 percentage of burining/stinging | Standard Deviation 22.261 |
| Placebo | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Burning/Stinging | Change at Week 2 | -9.66 percentage of burining/stinging | Standard Deviation 23.478 |
p-value: 0.61595% CI: [-4.223, 7.133]MMRM
Comparison: Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.09795% CI: [-0.866, 10.494]MMRM
Comparison: Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.71895% CI: [-4.69, 6.81]MMRM
Comparison: Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.29895% CI: [-2.728, 8.903]MMRM
Secondary
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Eye Dryness
Participants rated ocular symptom of eye dryness by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).
Time frame: Baseline; Weeks 1, 2, 4, and 8
Population: ITT population with available data was analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Eye Dryness | Change at Week 1 | -6.98 percentage of eye dryness | Standard Deviation 22.84 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Eye Dryness | Change at Week 2 | -10.34 percentage of eye dryness | Standard Deviation 23.308 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Eye Dryness | Change at Week 4 | -13.64 percentage of eye dryness | Standard Deviation 26.572 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Eye Dryness | Change at Week 8 | -16.19 percentage of eye dryness | Standard Deviation 30.625 |
| Placebo | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Eye Dryness | Change at Week 8 | -19.79 percentage of eye dryness | Standard Deviation 26.317 |
| Placebo | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Eye Dryness | Change at Week 1 | -9.23 percentage of eye dryness | Standard Deviation 21.209 |
| Placebo | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Eye Dryness | Change at Week 4 | -13.12 percentage of eye dryness | Standard Deviation 23.297 |
| Placebo | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Eye Dryness | Change at Week 2 | -12.52 percentage of eye dryness | Standard Deviation 22.974 |
Comparison: Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errorsp-value: 0.13695% CI: [-1.402, 10.273]MMRM
Comparison: Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.16595% CI: [-1.7, 9.966]MMRM
Comparison: Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.66595% CI: [-4.6, 7.207]MMRM
Comparison: Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.09995% CI: [-0.95, 10.995]MMRM
Secondary
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Foreign Body Sensation
Participants rated ocular symptom of foreign body sensation by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).
Time frame: Baseline; Weeks 1, 2, 4, and 8
Population: ITT population with available data was analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Foreign Body Sensation | Change at Week 1 | -4.63 percentage of foreign body sensation | Standard Deviation 23.06 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Foreign Body Sensation | Change at Week 2 | -7.93 percentage of foreign body sensation | Standard Deviation 23.489 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Foreign Body Sensation | Change at Week 4 | -7.83 percentage of foreign body sensation | Standard Deviation 25.806 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Foreign Body Sensation | Change at Week 8 | -7.81 percentage of foreign body sensation | Standard Deviation 30.745 |
| Placebo | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Foreign Body Sensation | Change at Week 8 | -11.58 percentage of foreign body sensation | Standard Deviation 25.182 |
| Placebo | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Foreign Body Sensation | Change at Week 1 | -4.06 percentage of foreign body sensation | Standard Deviation 23.349 |
| Placebo | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Foreign Body Sensation | Change at Week 4 | -6.90 percentage of foreign body sensation | Standard Deviation 22.919 |
| Placebo | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Foreign Body Sensation | Change at Week 2 | -8.26 percentage of foreign body sensation | Standard Deviation 22.783 |
Comparison: Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errorsp-value: 0.34395% CI: [-2.854, 8.191]MMRM
Comparison: Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.18895% CI: [-1.813, 9.232]MMRM
Comparison: Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.37195% CI: [-3.04, 8.143]MMRM
Comparison: Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.01795% CI: [1.259, 12.573]MMRM
Secondary
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Itching
Participants rated ocular symptom of itching by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).
Time frame: Baseline; Weeks 1, 2, 4, and 8
Population: ITT population with available data was analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Itching | Change at Week 1 | -6.49 percentage of itching | Standard Deviation 21.885 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Itching | Change at Week 2 | -8.39 percentage of itching | Standard Deviation 23.746 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Itching | Change at Week 4 | -10.31 percentage of itching | Standard Deviation 23.372 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Itching | Change at Week 8 | -11.12 percentage of itching | Standard Deviation 27.65 |
| Placebo | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Itching | Change at Week 8 | -14.33 percentage of itching | Standard Deviation 21.512 |
| Placebo | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Itching | Change at Week 1 | -5.52 percentage of itching | Standard Deviation 20.82 |
| Placebo | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Itching | Change at Week 4 | -9.78 percentage of itching | Standard Deviation 22.738 |
| Placebo | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Itching | Change at Week 2 | -9.07 percentage of itching | Standard Deviation 21.807 |
Comparison: Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.75495% CI: [-4.452, 6.147]MMRM
Comparison: Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.36895% CI: [-2.865, 7.731]MMRM
Comparison: Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.62195% CI: [-4.014, 6.715]MMRM
Comparison: Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.p-value: 0.08795% CI: [-0.688, 10.168]MMRM
Secondary
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Pain
Participants rated ocular symptom of pain by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).
Time frame: Baseline; Weeks 1, 2, 4, and 8
Population: ITT population with available data was analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Pain | Change at Week 1 | -6.27 percentage of pain | Standard Deviation 22.501 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Pain | Change at Week 2 | -5.00 percentage of pain | Standard Deviation 23.843 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Pain | Change at Week 4 | -6.27 percentage of pain | Standard Deviation 29.718 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Pain | Change at Week 8 | -7.23 percentage of pain | Standard Deviation 27.317 |
| Placebo | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Pain | Change at Week 8 | -9.83 percentage of pain | Standard Deviation 22.37 |
| Placebo | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Pain | Change at Week 1 | -5.63 percentage of pain | Standard Deviation 18.611 |
| Placebo | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Pain | Change at Week 4 | -8.27 percentage of pain | Standard Deviation 20.666 |
| Placebo | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Pain | Change at Week 2 | -7.25 percentage of pain | Standard Deviation 19.041 |
Comparison: Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errorsp-value: 0.61395% CI: [-3.799, 6.438]MMRM
Comparison: Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errorsp-value: 0.08395% CI: [-0.586, 9.653]MMRM
Comparison: Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errorsp-value: 0.16595% CI: [-1.508, 8.851]MMRM
Comparison: Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errorsp-value: 0.1195% CI: [-0.964, 9.522]MMRM
Secondary
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Photophobia
Participants rated ocular symptom of photophobia by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).
Time frame: Baseline; Weeks 1, 2, 4, and 8
Population: ITT population with available data was analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Photophobia | Change at Week 1 | -6.57 percentage of photophobia | Standard Deviation 22.155 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Photophobia | Change at Week 2 | -7.17 percentage of photophobia | Standard Deviation 22.689 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Photophobia | Change at Week 4 | -8.20 percentage of photophobia | Standard Deviation 28.014 |
| 0.25% Tanfanercept Ophthalmic Solution | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Photophobia | Change at Week 8 | -10.71 percentage of photophobia | Standard Deviation 30.328 |
| Placebo | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Photophobia | Change at Week 8 | -12.18 percentage of photophobia | Standard Deviation 28.722 |
| Placebo | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Photophobia | Change at Week 1 | -3.56 percentage of photophobia | Standard Deviation 22.871 |
| Placebo | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Photophobia | Change at Week 4 | -9.10 percentage of photophobia | Standard Deviation 26.35 |
| Placebo | Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Photophobia | Change at Week 2 | -5.54 percentage of photophobia | Standard Deviation 23.594 |
Comparison: Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errorsp-value: 0.86195% CI: [-5.232, 6.254]MMRM
Comparison: Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errorsp-value: 0.54895% CI: [-3.983, 7.497]MMRM
Comparison: Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errorsp-value: 0.1895% CI: [-1.839, 9.777]MMRM
Comparison: Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errorsp-value: 0.18995% CI: [-1.941, 9.807]MMRM
Secondary
Ora Calibra® Drop Comfort Assessment at Week 1
Ora Calibra® drop comfort scale ranged from 0 to 10. A score of 0 indicated comfortable and 10 indicated uncomfortable. Lower score indicated better comfort level. Immediately Upon Instillation, 1 Minute Post Instillation and 2 Minutes Post Instillation at Week 1
Time frame: Week 1
Population: ITT population with available data was analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.25% Tanfanercept Ophthalmic Solution | Ora Calibra® Drop Comfort Assessment at Week 1 | Immediately Upon Instillation at Week 1 | 2.55 score on a scale | Standard Deviation 2.673 |
| 0.25% Tanfanercept Ophthalmic Solution | Ora Calibra® Drop Comfort Assessment at Week 1 | 1 Minute Post Instillation at Week 1 | 1.95 score on a scale | Standard Deviation 2.063 |
| 0.25% Tanfanercept Ophthalmic Solution | Ora Calibra® Drop Comfort Assessment at Week 1 | 2 Minutes Post Instillation at Week 1 | 1.56 score on a scale | Standard Deviation 1.884 |
| Placebo | Ora Calibra® Drop Comfort Assessment at Week 1 | Immediately Upon Instillation at Week 1 | 2.72 score on a scale | Standard Deviation 2.532 |
| Placebo | Ora Calibra® Drop Comfort Assessment at Week 1 | 1 Minute Post Instillation at Week 1 | 2.21 score on a scale | Standard Deviation 2.174 |
| Placebo | Ora Calibra® Drop Comfort Assessment at Week 1 | 2 Minutes Post Instillation at Week 1 | 1.79 score on a scale | Standard Deviation 2.058 |
Comparison: Immediately Upon Instillation at Week 1p-value: 0.59895% CI: [-0.822, 0.475]t-test, 2 sided
Comparison: 1 Minute Post Instillation at Week 1p-value: 0.34395% CI: [-0.783, 0.273]t-test, 2 sided
Comparison: 2 Minutes Post Instillation at Week 1p-value: 0.35995% CI: [-0.721, 0.262]t-test, 2 sided