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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06225973
Other study ID # TL-925-303
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


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
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