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TL-925 Arm for Dry Eye Syndrome

Phase 2
Recruiting
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
Awards & highlights

Study 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.Check my eligibility
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.See study design
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
~110

Find a Location

Who is running the clinical trial?

Telios Pharma, Inc.Lead Sponsor
9 Previous Clinical Trials
737 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants currently being sought for enrollment in this study?

"Per clinicaltrials.gov, this ongoing medical research is actively seeking suitable participants. The trial was originally listed on February 6th, 2024 and last modified on March 12th, 2024."

Answered by AI

What is the level of safety associated with TL-925 Arm for individuals undergoing treatment?

"According to our evaluation at Power, the safety rating for TL-925 Arm is 2 on a scale of 1 to 3. This assessment aligns with it being a Phase 2 trial where some safety data exists but no efficacy data has been observed yet."

Answered by AI

Are there multiple locations conducting this study within the region?

"Several sites, including Cornea and Cataract Consultants of Arizona in Phoenix, Piedmont Eye Center in Lynchburg, and Global Research Management in Glendale, are among the 9 locations where participants can enroll for this investigation."

Answered by AI

What is the cumulative count of individuals who are participating in this clinical study?

"A total of 670 suitable individuals meeting the defined criteria are needed to partake in this research endeavor. Eligible patients have the opportunity to engage in the study at diverse locations, including Cornea and Cataract Consultants of Arizona situated in Phoenix, Arizona, as well as Piedmont Eye Center located in Lynchburg, Virginia."

Answered by AI

Who else is applying?

What site did they apply to?
Cornea and Cataract Consultants of Arizona
Nvision
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

Constant dry eyes both eyes. Tired of constantly having to apply artificial tears which are expensive and annoying.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study of TL-925 Ophthalmic Emulsion as a Treatment for Dry Eye Disease
2024. "A Study of TL-925 Ophthalmic Emulsion as a Treatment for Dry Eye Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06225973.
All > Paid Studies Boston > Greensboro
~447 spots leftby Dec 2024
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