TTAX03 for Dry Eye Syndrome
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this randomized, controlled, multicenter study is to evaluate the safety and efficacy of TTAX03 in participants with mild to moderate DED.The primary question it aims to answer is if TTAX03 is safe. The secondary is the effectiveness.Researchers will compare 10mg of TTAX03 reconstituted in 150, 300, or 600 uL saline to the saline control group to look at effectiveness.Participants will be randomized to a treatment group one time and be evaluated at 5 different study visits.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are using a nasal cholinergic agonist or topical glaucoma medication, you may need to stop as these are listed in the exclusion criteria.
Are You a Good Fit for This Trial?
This trial is for people with mild to moderate dry eye disease (DED). Participants should not have any other serious eye conditions or infections. They must be willing to attend five study visits.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive TTAX03 or saline control via bandage contact lens for 5 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- TTAX03
Find a Clinic Near You
Who Is Running the Clinical Trial?
BioTissue Holdings, Inc
Lead Sponsor