TL-925 for Dry Eye Syndrome

Recruiting in Palo Alto (17 mi)

+18 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Telios Pharma, Inc.

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

This trial is for people who have had dry eye disease (DED) for at least 6 months. They should have a specific range of tear production as measured by the Schirmer's test. Women able to bear children and their male partners must use effective birth control during the study. People with recent eye surgeries, infections, inflammation, or other significant eye conditions can't participate.

Inclusion Criteria

Unanesthetized Schirmer's test score (STS) of ≤ 10mm and ≥ 1mm in the study eye

My partner and I are using effective birth control during the study.

I have been diagnosed with dry eye disease for over 6 months.

Exclusion Criteria

Any clinically significant slit lamp finding

Best-corrected visual acuity ≥0.7 logarithm of the minimum angle of resolution

I do not have any current eye infections or inflammation.

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Treatment Details

Interventions

TL-925 (Other)

Trial OverviewThe trial is testing TL-925 Ophthalmic Emulsion against a placebo in patients with moderate to severe DED. Participants will be randomly assigned to one of two groups: one receiving TL-925 and the other a placebo, both as eye drops twice daily for six weeks after an initial two-week screening phase.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TL-925 ArmExperimental Treatment1 Intervention

TL-925 will be administered OU BID

Group II: Vehicle ArmPlacebo Group1 Intervention

Vehicle will be administered OU BID