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

Dry Eye Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06225973
• Other study ID #: TL-925-303
• Status: Recruiting
• Phase: Phase 2
• Start date: February 6, 2024
• Est. completion date: December 2024

Study information

• Verified date: June 2024
• Source: Telios Pharma, Inc.
• Contact: John Mei
• Phone: 650-542-0136
• Email: jmei[@]teliospharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this prospective, phase 2b, multicenter, randomized, double-masked, vehicle-controlled, parallel-arm study, approximately 880 subjects with moderate to severe dry eye disease (DED) will be randomly assigned (1:1) to receive either TL-925 or vehicle as topical ophthalmic eye drops administered bilaterally BID.

The study will comprise two phases: a two-week screening phase/run-in and a six-week double-masked treatment phase.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 880
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

• 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

• Best-corrected visual acuity =0.7 logarithm of the minimum angle of resolution

• Any keratorefractive surgery within the last 12 months

• Any intraocular or extraocular surgery within 3 months

• Any blepharoplasty or corneal transplant in either eye

• Any form of punctual, or intracanalicular occlusion in either eye

• History or presence of any ocular disorder that may interfere with study results

Related Conditions & MeSH terms

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

Intervention

Drug:
• TL-925
TL-925 is an eye drop.

Other:
• Placebo
The composition of the vehicle 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	Andover	Massachusetts
United States	Pankratz Eye	Columbus	Indiana
United States	Scott and Christie EyeCare Associates	Cranberry Township	Pennsylvania
United States	Oculus Research	Garner	North Carolina
United States	Global Research Management	Glendale	California
United States	Advancing Vision Research	Goodlettsville	Tennessee
United States	Nvision - La Mesa	La Mesa	California
United States	Wilmington Eye	Leland	North Carolina
United States	Butchertown Clinical	Louisville	Kentucky
United States	Piedmont Eye Center	Lynchburg	Virginia
United States	Total Eye Care, PA	Memphis	Tennessee
United States	Wyse Eyecare	Northbrook	Illinois
United States	Cornea and Cataract Consultants of Arizona	Phoenix	Arizona
United States	Andover Eye Associates - Raynham	Raynham	Massachusetts
United States	Advancing Vision Research	Smyrna	Tennessee
United States	Nvision - Torrance	Torrance	California
United States	NEERA - Westborough	Westborough	Massachusetts
United States	NEERA - Woburn	Woburn	Massachusetts

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	To evaluate the efficacy of TL-925 compared to vehicle on tear production	Percentage of subjects who achieve =10 mm improvement in Schirmer's test score	Baseline to Day 29