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

Launched by TELIOS PHARMA, INC. · Jan 17, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called TL-925, which is an eye drop designed to help people with moderate to severe dry eye disease (DED). The study will involve around 880 participants who will be randomly assigned to receive either TL-925 or a placebo (a non-active version of the eye drop) for six weeks. To be eligible, participants must have been diagnosed with dry eye disease for at least six months and have specific test results that indicate they have moderate to severe symptoms.

The trial will take place over two phases: a two-week screening period followed by the six-week treatment phase. Participants will have their eyes examined and will need to use effective contraception if they are of childbearing age. During the trial, they can expect to receive either the treatment or the placebo, and they will not know which one they are getting to ensure unbiased results. It's important to note that individuals with certain eye conditions or recent eye surgeries may not be eligible to participate in this study.

Gender

ALL

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