Clinical trial NCT06225973: A Study of TL-925 Ophthalmic Emulsion as a Treatment for Dry Eye Disease
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Dry Eye Disease
Lead sponsor: Telios Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2024-01-26
Enrollment: 880
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: To evaluate the efficacy of TL-925 compared to vehicle on tear production
timeFrame: Baseline to Day 29
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Cornea and Cataract Consultants of Arizona
state: Arizona
city: Glendale
country: United States
facility: Global Research Management
state: California
city: La Mesa
country: United States
facility: Nvision - La Mesa
state: California
city: Torrance
country: United States
facility: Nvision - Torrance
state: California
city: Northbrook
country: United States
facility: Wyse Eyecare
state: Illinois
city: Columbus
country: United States
facility: Pankratz Eye
state: Indiana
city: Louisville
country: United States
facility: Butchertown Clinical
state: Kentucky
city: Andover
country: United States
facility: Andover Eye Associates - Andover
state: Massachusetts
city: Raynham
country: United States
facility: Andover Eye Associates - Raynham
state: Massachusetts
city: Westborough
country: United States
facility: NEERA - Westborough
state: Massachusetts
city: Woburn
country: United States
facility: NEERA - Woburn
state: Massachusetts
city: Garner
country: United States
facility: Oculus Research
state: North Carolina
city: Leland
country: United States
facility: Wilmington Eye
state: North Carolina
city: Cranberry Township
country: United States
facility: Scott and Christie EyeCare Associates
state: Pennsylvania
city: Goodlettsville
country: United States
facility: Advancing Vision Research
state: Tennessee
city: Memphis
country: United States
facility: Total Eye Care, PA
state: Tennessee
city: Smyrna
country: United States
facility: Advancing Vision Research
state: Tennessee
city: Lynchburg
country: United States
facility: Piedmont Eye Center
state: Virginia
Study officials:
References: