NCT05143281

The SITE Study - Dexamethasone Ophthalmic Insert In OR on Day of Surgery Versus In-office Post-Op Day 1

A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of Treatment With an Intracanalicular Dexamethasone (0.4mg) Ophthalmic Insert in the Operating Room Following Cataract Surgery/Intraocular Lens Implant (IOL) Compared to Insertion 1-day Post-op - The SITE Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Grene Vision Group · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

To assess the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert in the operating room following cataract surgery/intraocular lens implant (IOL) compared to insertion 1-day post-op.

Detailed description

This is a randomized, controlled study to evaluate the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert in the operating room following cataract surgery/intraocular lens implant (IOL) compared to insertion 1-day post-op. There will be approximately 50 eyes with two groups: Group 1 (up to 10 eyes) will receive the insert in the lower punctum on the day of surgery in the OR. Group 2 (up to 40 eyes) will receive the insert in the lower punctum on the day after surgery in the HOPD. Each subject's participation is expected to last for approximately 1 month and will be required to complete five scheduled visits over the course of the study period: Baseline (Screening Visit), Operative Visit/Insertion Day (Day 0), Day 1, Day 7 and Day 30.

Conditions

• Cataract

Interventions

Type	Name	Description
DRUG	Dexamethasone 0.4 MG [Dextenza]	Ophthalmic Intracanalicular Insert

Timeline

• Start date: 2021-12-13
• Primary completion: 2023-02-01
• Completion: 2023-02-01
• First posted: 2021-12-03
• Last updated: 2023-07-06

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study