A Study of TL-925 Ophthalmic Emulsion as a Treatment for Dry Eye Disease
- Registration Number
- NCT06225973
- Lead Sponsor
- Telios Pharma, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 880
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TL-925 Arm TL-925 TL-925 will be administered OU BID Vehicle Arm Placebo Vehicle will be administered OU BID
- Primary Outcome Measures
Name Time Method To evaluate the efficacy of TL-925 compared to vehicle on tear production Baseline to Day 29 Percentage of subjects who achieve ≥10 mm improvement in Schirmer's test score
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (17)
Wyse Eyecare
🇺🇸Northbrook, Illinois, United States
Nvision - Torrance
🇺🇸Torrance, California, United States
Andover Eye Associates - Andover
🇺🇸Andover, Massachusetts, United States
Oculus Research
🇺🇸Garner, North Carolina, United States
Global Research Management
🇺🇸Glendale, California, United States
Pankratz Eye
🇺🇸Columbus, Indiana, United States
Andover Eye Associates - Raynham
🇺🇸Raynham, Massachusetts, United States
NEERA - Westborough
🇺🇸Westborough, Massachusetts, United States
Nvision - La Mesa
🇺🇸La Mesa, California, United States
NEERA - Woburn
🇺🇸Woburn, Massachusetts, United States
Cornea and Cataract Consultants of Arizona
🇺🇸Phoenix, Arizona, United States
Scott and Christie EyeCare Associates
🇺🇸Cranberry Township, Pennsylvania, United States
Total Eye Care, PA
🇺🇸Memphis, Tennessee, United States
Butchertown Clinical
🇺🇸Louisville, Kentucky, United States
Wilmington Eye
🇺🇸Leland, North Carolina, United States
Advancing Vision Research
🇺🇸Smyrna, Tennessee, United States
Piedmont Eye Center
🇺🇸Lynchburg, Virginia, United States