Harrow Inc
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.
This document is Protocol TR-03-001, dated 26 January 2026, for a Phase 3, prospective, multicenter, randomized, parallel-arm, double-masked, placebo-controlled clinical trial sponsored by Harrow Inc. The study evaluates TRIESENCE® (triamcinolone acetonide injectable suspension) given as a 100 µL subconjunctival injection for the treatment of ocular inflammation and pain after ophthalmic surgery. The protocol says about 250 subjects will be enrolled across 16 sites, with total subject participation of about 120 days including screening, surgery, postoperative follow-up through Day 90, and a po…
Inclusion Criteria: * Adults ≥18 years of age * Scheduled to undergo ophthalmic surgery, primarily cataract surgery with intraocular lens implantation (phacoemulsification) * Clear corneal incision ≤2.2 mm in the study eye * No ocular pain (NPRS = 0) in the study eye at baseline * No clinically significant anterior chamber inflammation at baseline * Able and willing to provide informed consent and comply with study procedures Exclusion Criteria: * Active ocular infection or inflammation (e.g., uveitis, conjunctivitis, keratitis) * History of glaucoma, elevated intraocular pressure, or high…
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.
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.
Arctuva estimate
Actual pay is set by the research site.
Verify or correct the compensation shown for this listing.