| 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. | ITT population with available data was analyzed. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, Day 57 (Week 8) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | Placebo | Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period. |
| | | Title | Denominators | Categories |
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| Baseline | - ParticipantsOG000130
- ParticipantsOG001130
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| 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. | MMRM | | 0.764 | | LS Mean Difference | -0.03 | Standard Error of the Mean | 0.094 | 2-Sided | 95 | -0.214 | 0.157 | | | | | Superiority | |
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| 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). | ITT population with available data were analyzed. | Posted | | Mean | Standard Deviation | percentage of dryness | | Baseline, Day 57 (Week 8) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Placebo | Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period. |
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| 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. | ITT population with available data was analyzed. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline; Weeks 1, 2, 4, and 8 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Placebo | Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period. |
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| 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. | ITT population with available data was analyzed. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline; Weeks 1, 2, 4, and 8 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Placebo | Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period. |
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| 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. | ITT population with available data was analyzed. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline; Weeks 1, 2, 4, and 8 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Placebo | Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period. |
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| 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. | ITT population with available data was analyzed. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline; Weeks 1, 2, 4, and 8 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Placebo | Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period. |
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| 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. | ITT population with available data was analyzed. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline; Weeks 1, 2, 4, and 8 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Placebo | Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period. |
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| 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. | ITT population with available data was analyzed. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline; Weeks 1, 2, 4, and 8 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Placebo | Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period. |
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| 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. | ITT population with available data was analyzed. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline; Weeks 1, 2, 4, and 8 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | Placebo | Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period. |
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| 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. | ITT population with available data was analyzed. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline; Weeks 1, 2, 4, and 8 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Placebo | Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period. |
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| 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. | ITT population with available data was analyzed | Posted | | Mean | Standard Deviation | score on a scale | | Baseline; Weeks 1, 2, 4, and 8 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Placebo | Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period. |
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| 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. | ITT population with available data was analyzed | Posted | | Mean | Standard Deviation | score on a scale | | Baseline; Weeks 1, 2, 4, and 8 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Placebo | Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period. |
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| 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. | ITT population with available data was analyzed | Posted | | Mean | Standard Deviation | score on a scale | | Baseline; Weeks 1, 2, 4, and 8 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | Placebo | Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period. |
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| 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. | ITT population with available data was analyzed | Posted | | Mean | Standard Deviation | score on a scale | | Baseline; Weeks 1, 2, 4, and 8 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | Placebo | Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period. |
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| 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. | ITT population with available data was analyzed | Posted | | Mean | Standard Deviation | score on a scale | | Baseline; Weeks 1, 2, 4, and 8 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Placebo | Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period. |
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| 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. | ITT population with available data was analyzed | Posted | | Mean | Standard Deviation | score on a scale | | Baseline; Weeks 1, 2, 4, and 8 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Placebo | Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period. |
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| 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. | ITT population with available data was analyzed | Posted | | Mean | Standard Deviation | score on a scale | | Baseline; Weeks 1, 2, 4, and 8 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Placebo | Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period. |
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| 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. | ITT population with available data was analyzed | Posted | | Mean | Standard Deviation | score on a scale | | Baseline; Weeks 1, 2, 4, and 8 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Placebo | Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period. |
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| 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. | ITT population with available data was analyzed | Posted | | Mean | Standard Deviation | score on a scale | | Baseline; Weeks 1, 2, 4, and 8 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Placebo | Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period. |
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| 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. | ITT population with available data was analyzed | Posted | | Mean | Standard Deviation | mm | | Baseline; Weeks 2, 4, and 8 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | Placebo | Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period. |
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| 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. | ITT population with available data was analyzed | Posted | | Mean | Standard Deviation | seconds | | Baseline; Weeks 1, 2, 4, and 8 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Placebo | Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period. |
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| 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). | ITT population with available data was analyzed | Posted | | Mean | Standard Deviation | percentage of burining/stinging | | Baseline; Weeks 1, 2, 4, and 8 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | Placebo | Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period. |
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| 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). | ITT population with available data was analyzed | Posted | | Mean | Standard Deviation | percentage of foreign body sensation | | Baseline; Weeks 1, 2, 4, and 8 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | Placebo | Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period. |
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| 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). | ITT population with available data was analyzed | Posted | | Mean | Standard Deviation | percentage of itching | | Baseline; Weeks 1, 2, 4, and 8 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Placebo | Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period. |
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| 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). | ITT population with available data was analyzed | Posted | | Mean | Standard Deviation | percentage of blurred vision | | Baseline; Weeks 1, 2, 4, and 8 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Placebo | Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period. |
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| 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). | ITT population with available data was analyzed | Posted | | Mean | Standard Deviation | percentage of eye dryness | | Baseline; Weeks 1, 2, 4, and 8 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Placebo | Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period. |
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| 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). | ITT population with available data was analyzed | Posted | | Mean | Standard Deviation | percentage of photophobia | | Baseline; Weeks 1, 2, 4, and 8 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Placebo | Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period. |
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| 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). | ITT population with available data was analyzed | Posted | | Mean | Standard Deviation | percentage of pain | | Baseline; Weeks 1, 2, 4, and 8 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Placebo | Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period. |
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| 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. | ITT population with available data was analyzed | Posted | | Mean | Standard Deviation | score on a scale | | Baseline; Weeks 1, 2, 4, and 8 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Placebo | Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period. |
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| 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. | ITT population with available data was analyzed | Posted | | Mean | Standard Deviation | score on a scale | | Baseline; Weeks 1, 2, 4, and 8 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Placebo | Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period. |
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| 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. | ITT population with available data will be analyzed | Posted | | Mean | Standard Deviation | score on a scale | | Baseline; Weeks 1, 2, 4, and 8 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Placebo | Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period. |
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| 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. | ITT population with available data will be analyzed | Posted | | Mean | Standard Deviation | score on a scale | | Baseline; Weeks 1, 2, 4, and 8 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Placebo | Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period. |
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| 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. | ITT population with available data will be analyzed | Posted | | Mean | Standard Deviation | score on a scale | | Baseline; Weeks 1, 2, 4, and 8 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | Placebo | Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period. |
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| 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. | ITT population with available data will be analyzed | Posted | | Mean | Standard Deviation | score on a scale | | Baseline; Weeks 1, 2, 4, and 8 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | Placebo | Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period. |
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| 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 | ITT population with available data was analyzed | Posted | | Mean | Standard Deviation | score on a scale | | Week 1 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | Placebo | Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period. |
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