A Study in the Treatment of Mild to Moderate Dry Eye Disease Comparing Saline to TTAX03. (NCT06780306) | Clinical Trial Compass
CompletedPhase 2
A Study in the Treatment of Mild to Moderate Dry Eye Disease Comparing Saline to TTAX03.
United States74 participantsStarted 2024-12-12
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥ 18 years old.
. Provision of signed and dated informed consent form.
. Baseline VAS Dryness score ≥40
. Baseline Ocular Surface Disease Index (OSDI) score ≥ 13.
. Baseline corneal fluorescein staining with a total score ≥ 4 but ≤13, and ≥ 2 in at least one region, by the NEI Grading System† in the study eye.
. In the opinion of the investigator, the participant can follow oral and written instructions.
. In the opinion of the investigator, the participant can complete all study procedures and visits.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this Phase 2 trial has already completed, would you be able to share or look up any preliminary safety findings from the 12-week monitoring period, and what they might mean for someone with my level of dry eye?
2This trial compared TTAX03 against saline — does that tell us anything useful about how TTAX03 performs compared to the standard treatments I'm already being offered or considering?
3Given that the trial focused on mild to moderate dry eye but also included people with severe keratitis, where would my condition fall, and does that affect how relevant these results might be for me?
4Since this was a Phase 2 study primarily designed to evaluate safety rather than fully prove effectiveness, what would need to happen in later-phase trials before TTAX03 could become a realistic option for patients like me?
5Are there any currently enrolling trials or approved treatments for dry eye disease that might be worth considering now, while TTAX03 is still being researched?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Determine 12 week ocular and general safety after application of TTAX03.
. Has a corneal ectatic disorder or other ocular surface disease such as limbal stem cell deficiency or a cicatricial component (e.g., symblepharon, fornix foreshortening and lid margin/lashes abnormality) caused for example by oGVHD, irradiation, chemical burns, trachoma, Stevens Johnson syndrome/toxic epidermal necrolysis, ocular cicatricial pemphigoid, or the destruction of conjunctival goblet cells (as with vitamin A deficiency).
. Has severe blepharitis or severe obvious inflammation of the lid margin.
. Has severe conjunctivochalasis.
. Has nocturnal exposure e.g. incomplete closure or lagophthalmos or floppy eyelid.
. Has epithelial basement membrane dystrophy (i.e., map-dot-fingerprint dystrophy) or history of recurrent corneal erosion
. Has neuropathic corneal pain
. Has a sunken globe (due to the reduction or loss of orbital fat)
. Has severe DED per corneal fluorescein staining with a total score ≥ 13by the NEI Grading System in either eye.