"A Prospective Study of the Efficacy of Intracameral Dexamethasone (Dexycu™) Compared to Standard of Care Treatment for Post-Cataract Surgical Pain and Anterior Chamber Inflammation"

PHASE4CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

February 20, 2020

Primary Completion Date

December 22, 2022

Study Completion Date

December 22, 2022

Conditions
Cataract
Interventions
DRUG

Dexycu

"This is a contra-lateral randomized study, meaning that in clinic after a patient is identified as a candidate we will flip a coin for selection of the eye that is going to receive the Dexycu™ implant (the implant will be placed intracapsularly at the optic haptic junction of the IOL). The patients will receive the SAME topical regimen (Eye with Dexycu™: no steroid, Eye without Dexycu™: steroid will be used). The Dexycu™, topical NSAID, and antibiotic regimen will be provided to all patients in the study, at no cost, in order to avoid difficulties with compliance, insurance, and follow up."

DRUG

Standard of Care post operative eye drops (steroid, antibiotic, NSAID)

"This is a contra-lateral randomized study, meaning that in clinic after a patient is identified as a candidate we will flip a coin for selection of the eye that is going to receive the Dexycu™ implant (the implant will be placed intracapsularly at the optic haptic junction of the IOL). The patients will receive the SAME topical regimen (Eye with Dexycu™: no steroid, Eye without Dexycu™: steroid will be used). The Dexycu™, topical NSAID, and antibiotic regimen will be provided to all patients in the study, at no cost, in order to avoid difficulties with compliance, insurance, and follow up."

Trial Locations (1)

33770

The Eye Institute of West Florida, Largo

Sponsors
All Listed Sponsors
collaborator

EyePoint Pharmaceuticals, Inc.

INDUSTRY

lead

The Eye Institute of West Florida

OTHER

NCT04781335 - "A Prospective Study of the Efficacy of Intracameral Dexamethasone (Dexycu™) Compared to Standard of Care Treatment for Post-Cataract Surgical Pain and Anterior Chamber Inflammation" | Biotech Hunter | Biotech Hunter