A Study of TL-925 Ophthalmic Emulsion as a Treatment for Dry Eye Disease
Launched by TELIOS PHARMA, INC. · Jan 17, 2024
Trial Information
Current as of July 01, 2025
Active, not recruiting
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
About Telios Pharma, Inc.
Telios Pharma, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative therapies for unmet medical needs in the field of dermatology and other specialty areas. With a commitment to advancing patient care, Telios leverages cutting-edge scientific research and a robust pipeline of product candidates aimed at addressing conditions characterized by inflammation and tissue repair. The company’s mission is to transform the standard of care through the discovery and development of novel treatments that enhance the quality of life for patients.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Memphis, Tennessee, United States
Glendale, California, United States
Lynchburg, Virginia, United States
Phoenix, Arizona, United States
Cranberry Township, Pennsylvania, United States
Raynham, Massachusetts, United States
Goodlettsville, Tennessee, United States
Garner, North Carolina, United States
Smyrna, Tennessee, United States
Andover, Massachusetts, United States
Leland, North Carolina, United States
Northbrook, Illinois, United States
La Mesa, California, United States
Torrance, California, United States
Westborough, Massachusetts, United States
Torrance, California, United States
Columbus, Indiana, United States
Louisville, Kentucky, United States
Woburn, Massachusetts, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported