A Phase 2 Randomized, Controlled, Multicenter, Dose Optimization Study of TTAX03 in the Treatment of Mild to Moderate Dry Eye Disease (DED)
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
University California Berkeley
RECRUITING
Berkeley
Florida
Advanced Research, LLC.
RECRUITING
Deerfield Beach
Massachusetts
Eye Health Vision Center/Claris Vision LLC
RECRUITING
South Dartmouth
Minnesota
Southwest Eye Care
RECRUITING
Chaska
Mississippi
University of Mississippi Medical Center
RECRUITING
Jackson
North Carolina
Wilmington Eye at Brunswick Forest
RECRUITING
Leland
CORE, Inc. / Vita Eye Clinic
RECRUITING
Shelby
New Jersey
Eye Associates of North Jersey
RECRUITING
Dover
Northern New Jersey Eye Institute
RECRUITING
South Orange
Texas
Westlake Eye Specialists
RECRUITING
Austin
Contact Information
Primary
Director Clinical Operations
mpynes@biotissue.com
786-932-2583
Backup
VP Clinical Operations
(678) 722-9923
Time Frame
Start Date:2024-12-12
Estimated Completion Date:2025-12
Participants
Target number of participants:72
Treatments
Experimental: 10mg TTAX03 reconstituted in 150 uL saline
For all four groups, 100 mL of reconstituted solution will be applied into the concave bowl of a bandage contact lens and inserted into the study eye.
Active_comparator: 10mg TTAX03 reconstituted in 300 uL saline
For all four groups, 100 mL of reconstituted solution will be applied into the concave bowl of a bandage contact lens and inserted into the study eye.
Active_comparator: 10mg TTAX03 reconstituted in 600 uL saline
For all four groups, 100 mL of reconstituted solution will be applied into the concave bowl of a bandage contact lens and inserted into the study eye.
Placebo_comparator: 300 uL of saline
For all four groups, 100 mL of reconstituted solution will be applied into the concave bowl of a bandage contact lens and inserted into the study eye.