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TL-925 for Dry Eye Syndrome

Phase 2
Waitlist Available
Research Sponsored by Telios Pharma, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to day 29

Summary

This trial is looking at a new eye drop called TL-925 for people with moderate to severe dry eye disease. Around 670 participants will be randomly assigned to use either TL-925 or a control

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
While specific side effects are not listed here, typical side effects from ophthalmic emulsions may include temporary vision blurring, discomfort or irritation in the eyes upon application, redness, itching or watering of eyes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to day 29
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 29 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To evaluate the efficacy of TL-925 compared to vehicle on tear production

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TL-925
2023
Completed Phase 2
~190

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Who is running the clinical trial?

Telios Pharma, Inc.Lead Sponsor
9 Previous Clinical Trials
719 Total Patients Enrolled
~0 spots leftby Dec 2024
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