What this study is
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.
What's being tested
- Sham (No Treatment)
Intervention · PROCEDURE
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)
Intervention · DRUG
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.
Study details
- 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
- Sponsor
- Harrow Inc
- Conditions
- Postoperative Ocular Inflammation · Postoperative Ocular Pain
- Enrolling
- 250 people
- Starts
- 2026-05-25
- Est. completion
- 2027-03
- Design
- Double-blind, randomized, parallel groups, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- Active ocular infection or inflammation (e.g., uveitis, conjunctivitis, keratitis)
- History of glaucoma, elevated intraocular pressure, or high risk for steroid-induced IOP rise
- Significant retinal or macular pathology (e.g., diabetic retinopathy, macular edema)
- Prior ocular surgery in the study eye within a defined recent period
- Use of prohibited concomitant medications (e.g., certain corticosteroids or NSAIDs)
- Known hypersensitivity to triamcinolone acetonide or formulation components
- Uncontrolled systemic disease that could interfere with study participation
- Surgical complications or conditions that could confound outcome assessments
- Participation in another clinical trial within a restricted timeframe
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openSilverstein Eye Center
Kansas City, Missouri, United States
Study team
Sponsor
Harrow Inc
Study ID TR-03-001
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.