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

Dry Eye Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05745064
• Other study ID #: TL-925-301
• Status: Completed
• Phase: Phase 2
• Start date: February 27, 2023
• Est. completion date: July 11, 2023

Study information

• Verified date: November 2023
• Source: Telios Pharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: July 11, 2023
• Est. primary completion date: July 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• TL-925
TL-925 is an eye drop.
• Placebo
The composition of the placebo is identical to the active formulation except for the exclusion of the active ingredient.

Locations

Country	Name	City	State
United States	Andover Eye Associates	Andover	Massachusetts
United States	Vision Institute	Colorado Springs	Colorado
United States	Michael Washburn Center for Ophthalmic Research, LLC.	Indianapolis	Indiana
United States	Aesthetic Eye Care	Newport Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
Telios Pharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events during screening & treatment period		Baseline to the end of day 29 (±2 days)
Secondary	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)
Secondary	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)
Secondary	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)