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
| Verified date | March 2024 |
| Source | Telios Pharma, Inc. |
| Contact | John Mei |
| Phone | 650-542-0136 |
| jmei[@]teliospharma.com | |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
In this prospective, phase 2b, multicenter, randomized, double-masked, vehicle-controlled, parallel-arm study, approximately 670 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.
| Status | Recruiting |
| Enrollment | 670 |
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| 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 | Piedmont Eye Center | Lynchburg | Virginia |
| United States | Total Eye Care, PA | Memphis | Tennessee |
| United States | Cornea and Cataract Consultants of Arizona | Phoenix | Arizona |
| United States | Nvision | Torrance | California |
| United States | NEERA - Westborough | Westborough | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Telios Pharma, Inc. |
United States,
| 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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