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Tavilermide Eye Drops for Dry Eye

Phase 3
Waitlist Available
Research Sponsored by Mimetogen Pharmaceuticals USA, 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 85
Awards & highlights

Study Summary

This trial will test if a new eye drop can treat dry eye symptoms better than a fake drop.

Who is the study for?
This trial is for individuals with dry eye disease for at least 6 months, who've been using artificial tears. They should have specific test scores indicating dry eyes but can't join if they're pregnant, not using birth control, have uncontrolled diseases, or significant eye findings unrelated to dry eye.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of a 5% Tavilermide ophthalmic solution against a placebo in treating signs and symptoms of dry eye disease.See study design
What are the potential side effects?
Potential side effects are not detailed here but may include typical reactions to ophthalmic solutions such as irritation, redness, discomfort or blurred vision.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to day 85
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 85 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in Eye Dryness Score as Measured by the VAS
Change From Baseline in Total Corneal Fluorescein Staining as Measured by the NEI Scale

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: 5% Tavilermide ophthalmic solutionExperimental Treatment1 Intervention
Group II: Vehicle ophthalmic solutionPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Mimetogen Pharmaceuticals USA, Inc.Lead Sponsor
5 Previous Clinical Trials
2,005 Total Patients Enrolled

Media Library

5% Tavilermide ophthalmic solution (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05848128 — Phase 3
Dry Eye Syndrome Research Study Groups: 5% Tavilermide ophthalmic solution, Vehicle ophthalmic solution
Dry Eye Syndrome Clinical Trial 2023: 5% Tavilermide ophthalmic solution Highlights & Side Effects. Trial Name: NCT05848128 — Phase 3
5% Tavilermide ophthalmic solution (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05848128 — Phase 3

Frequently Asked Questions

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

What risks are associated with the utilization of 5% Tavilermide ophthalmic solution?

"Our organisation has rated 5% Tavilermide ophthalmic solution a 3 out of 3 due to prior clinical data suggesting its efficacy and multiple rounds of certified safety trials."

Answered by AI

What is the participant capacity of this research endeavor?

"Mimetogen Pharmaceuticals USA, Inc., is sponsoring this clinical trial in various locations including LoBue Laser and Eye Medical Center (Murrieta, California) and the Eye Research Foundation (Newport Beach, Florida). It requires 630 participants who meet inclusion criteria to be able to carry out its research."

Answered by AI

Is this research still enrolling participants?

"According to clinicaltrials.gov, the recruitment process for this experiment is ongoing; it was originally posted on June 28th 2023 and underwent its most recent revision two days ago."

Answered by AI

In what locations is this survey being conducted?

"Currently, this trial is accepting participants at 17 distinct medical sites. These include Murrieta, Newport Beach and Fort Myers along with 14 other locations. It is advisable to pick the closest location in order to reduce transportation burdens associated with taking part in this research."

Answered by AI

Who else is applying?

What state do they live in?
Indiana
What site did they apply to?
Price Vision Group
West Bay Eye Associates
Eye Doctors of Arizona
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2

Why did patients apply to this trial?

HAVE DEALT WITH DRY EYES AS LONG AS I CAN REMEMBER. I have yet to find anything that other than temporarily helps my dry eyes.
PatientReceived 1 prior treatment
I have used multiple OTC drops with little success. I would like to find something that works long term to relieve my dry eyes.
PatientReceived 2+ prior treatments
I have been prescribed Xidra, but it is too expensive. I would like to be part of a process where more drugs are available for dry eye.
PatientReceived 2+ prior treatments
I have been prescribed Restatis and Xidra, but they are both too expensive and I am currently not using them. I am hoping that if more drugs come onto the market, then they will become more affordable.
PatientReceived 2+ prior treatments
~0 spots leftby May 2024