Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as TRIESENCE (triamcinolone acetonide injectable suspension)
TRIESENCE · 1 trial · 2 indications
The proportion of subjects who achieve grade 0 anterior chamber cells (no detectable inflammatory cells) as assessed by slit-lamp biomicroscopy, indicating complete resolution of postoperative ocular inflammation.
The proportion of subjects reporting no ocular pain (score of 0 on the Numeric Pain Rating Scale \[NPRS\]), reflecting complete resolution of postoperative pain following ophthalmic surgery.
| Arm | Type | Description |
|---|---|---|
| TRIESENCE Treatment Arm | EXPERIMENTAL | 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 (Sham) Control Arm | PLACEBO_COMPARATOR | 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. |
| Name | Type | Description |
|---|---|---|
| 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. |
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 sig...