PREFERENTIAL Study

• Status: Withdrawn
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: All

Summary

To determine patient preference for the dexamethasone insert or topical prednisolone therapy through at Day 45 as measured by - Modified COMTOL survey.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborator: Ocular Therapeutix, Inc.
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• Age 18 years and older

• Presence of a visually significant cataract with plans to undergo clear cornea cataract surgery with phacoemulsification and implantation of a posterior chamber intraocular lens (IOL), and potential postoperative Snellen pinhole CDVA of at least 20/200 in both eyes

• 10 patients with mild-to-moderate primary open angle glaucoma and a visually significant cataract with plans to undergo clear cornea cataract surgery with phacoemulsification and implantation of a posterior chamber IOL combined with a Minimally Invasive Glaucoma Surgery (MIGS) procedure in both eyes

Exclusion Criteria:

• Active or history of chronic or recurrent inflammatory eye disease in either eye

• Ocular pain in either eye

• Proliferative diabetic retinopathy in either eye

• Significant macular pathology detected on macular optical coherence tomography evaluation at the screening visit in either eye

• Laser or incisional ocular surgery during the study period and 6 months prior in either eye

• Systemic concomitant pain medication management with pharmacologic class of oxycodone

• Systemic NSAID use

o Pre-procedural wash-out period for topical NSAIDS, ocular steroid, cyclosporine of 7 days

• Clinically significant macular edema (CSME)

• History of cystoid macular edema in the study eye