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

Phase 2

Completed

• Conditions: Dry Eye Disease
• Interventions: Drug: TL-925; Drug: Placebo

• Registration Number: NCT05745064
• Lead Sponsor: Telios Pharma, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-07
• Study First Submitted QC: 2023-02-22
• Study Start: 2023-02-27
• Study First Posted: 2023-02-27
• Primary Completion: 2023-07-11
• Study Completion: 2023-07-11
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-14
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TL-925 Arm	TL-925	TL-925 will be administered OU BID
Placebo Arm	Placebo	Placebo will be administered OU BID

Primary Outcome Measures

Name	Time	Method
Adverse events during screening & treatment period	Baseline to the end of day 29 (±2 days)

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Vision Institute; 🇺🇸 Colorado Springs, Colorado, United States

Andover Eye Associates; 🇺🇸 Andover, Massachusetts, United States

Aesthetic Eye Care; 🇺🇸 Newport Beach, California, United States

Michael Washburn Center for Ophthalmic Research, LLC.; 🇺🇸 Indianapolis, Indiana, United States