A Study of TL-925 as a Treatment for Dry Eye Disease

Study Overview
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Brief Summary
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In this prospective, Phase 2, multicenter, randomized, double-masked, placebo-controlled, parallel-arm study, approximately 100 subjects with moderate to severe dry eye disease (DED) will be randomly assigned (1:1) to receive either TL-925 or placebo as topical ophthalmic eye drops administered bilaterally BID. The study will comprise two phases: 2-weeks screening/run-in and 4-weeks double-masked treatment.

Official Title
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A Phase 2, Multicenter, Randomized, Double-masked, Placebo-controlled Study to Evaluate the Safety and Tolerability of TL-925 Ophthalmic Emulsion 0.1% in Subjects With Moderate to Severe Dry Eye Disease

Conditions
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Dry Eye Disease

Intervention / Treatment
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* Drug: TL-925
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals aged 18 years or older A diagnosis of dry eye disease for at least 6 months An unanesthetized Schirmer's test score (STS) of ≤ 10mm and ≥ 1mm in the study eye A tear film break-up time (TFBUT) of ≤ 5 seconds in the study eye A corneal fluorescein staining score of ≥ 2 in at least one region of the cornea A sum corneal fluorescein staining score of ≥ 4 in the study eye A total lissamine green conjunctival score of ≥ 2 in the study eye Female subjects of childbearing potential and their male partners must both use a highly effective contraception method during the study. Exclusion Criteria: Any clinically significant slit lamp finding Any ongoing ocular infection (bacterial, viral or fungal) or active ocular inflammation Any keratorefractive surgery within the last 12 months Any intraocular or extraocular surgery within 3 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: In this prospective, Phase 2, multicenter, randomized, double-masked, placebo-controlled, parallel-arm study, approximately 100 subjects with moderate to severe dry eye disease (DED) will be randomly assigned (1:1) to receive either TL-925 or placebo as topical ophthalmic eye drops administered bilaterally BID. The study will comprise two phases: 2-weeks screening/run-in and 4-weeks double-masked treatment.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TL-925 Arm<br>TL-925 will be administered OU BID | Drug: TL-925<br>* TL-925 is an eye drop.<br>|
| Placebo Comparator: Placebo Arm<br>Placebo will be administered OU BID | Drug: Placebo<br>* The composition of the placebo is identical to the active formulation except for the exclusion of the active ingredient.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events during screening & treatment period |  | Baseline to the end of day 29 (±2 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in corneal and conjunctival staining | Fluorescein staining by region in designated study eye will be used. Results will be assessed using a 5-point Corneal and Conjunctival Staining Scale. | Baseline to the end of day 29 (±2 days) | 
| Change from baseline in ocular discomfort | Visual analog scale (VAS) will be used. This will assess patients on a a 7-item 100-point scale based on ocular discomfort. | Baseline to the end of day 29 (±2 days) | 
| Change from baseline visual acuity | Best corrected visual acuity (BCVA) will be used to determine change in visual acuity from baseline. | Baseline to the end of day 29 (±2 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TL-925, Phase II