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 range18 Years
SexALL
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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
✕. 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).
What they're measuring
1
Determine 12 week ocular and general safety after application of TTAX03.