A Phase 3 Study Evaluating the Safety and Efficacy of TRIESENCE® (Injectable Suspension) for the Treatment of Ocular Inflammation and Pain After Ophthalmic Surgery

Conditions

• Postoperative Ocular Inflammation
• Postoperative Ocular Pain

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Sham (No Treatment) — 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) — 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

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.

Key Dates

First listed

Sep 22, 2026

Start date

May 25, 2026

Status verified

Sep 2026

Primary completion

Dec 31, 2026

Completion

Mar 31, 2027

Study Design

Enrollment

250 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: TRIESENCE Treatment Arm
  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.
• Placebo Comparator: Placebo Comparator: Placebo (Sham) Control Arm
  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.

Primary Outcome Measure

Proportion of Subjects With No Anterior Chamber Cells (Grade 0) at Day 14 [ Time Frame: Day 14 post-surgery ]

Locations (1)

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