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A Phase 3 Study Evaluating the Safety and Efficacy of TRIESENCE® (Injectable Suspension) for the Treatment of Ocular Inflammation and Pain After Ophthalmic Surgery
Sponsor: Harrow Inc
Summary
This study is designed to evaluate the safety and efficacy of TRIESENCE® (triamcinolone acetonide injectable suspension) in patients undergoing ophthalmic procedures. The trial will assess clinical outcomes associated with the use of the investigational product and support a supplemental New Drug Application (sNDA). Participants will receive the study drug as part of a controlled clinical setting, and outcomes related to safety, tolerability, and effectiveness will be evaluated.
Official title: A Phase 3, Prospective, Multicenter, Randomized, Parallel-Arm, Double-Masked, Placebo-Controlled Study Evaluating the Safety and Efficacy of TRIESENCE® (Injectable Suspension) for the Treatment of Ocular Inflammation and Pain After Ophthalmic Surgery
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
250
Start Date
2026-05-25
Completion Date
2027-03
Last Updated
2026-09-22
Healthy Volunteers
No
Interventions
Sham (No Treatment)
Participants undergo a sham injection procedure at the end of surgery that mimics the active treatment process without administering TRIESENCE. This control is used to maintain masking and allow comparison of efficacy and safety outcomes.
TRIESENCE (triamcinolone acetonide injectable suspension)
Participants receive a single 100 µL subconjunctival injection of TRIESENCE (triamcinolone acetonide injectable suspension) administered at the conclusion of ophthalmic surgery. The injection is given under aseptic conditions to evaluate its effectiveness in reducing postoperative ocular inflammation and pain.
Locations (1)
Silverstein Eye Center
Kansas City, Missouri, United States