TRIESENCE for Eye Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for people who have eye inflammation and pain after eye surgery (postoperative uveitis). Participants must be recovering from an ophthalmic procedure and meet other health requirements set by the study team.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- TRIESENCE (triamcinolone acetonide injectable suspension)
Trial Overview
The study compares TRIESENCE (a steroid injection given in the eye) to a sham treatment (no active medication) to see if it helps reduce inflammation and pain after eye surgery. Patients are randomly assigned to one of these groups.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Experimental Arm (TRIESENCE): 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.
Arm Description: Placebo Comparator Arm (Sham): 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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Harrow Inc
Lead Sponsor
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