NCT04316936

Omidria and Dexycu, or Omidria and Dextenza Compared to Topical Prednisolone Acetate 1% Following Cataract Surgery

Evaluation of Efficacy in the Resolution of Post-Operative Inflammation and Pain in Patients Receiving Omidria and Dexycu, or Omidria and Dextenza Compared to Topical Prednisolone Acetate 1% Following Cataract Surgery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Silverstein Eye Centers · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This research will evaluate the efficacy of Omidria and Dexycu, Omidria and Dextenza, and Omidria and prednisolone acetate 1% in the resolution of post-operative inflammation and pain following cataract surgery.

Detailed description

Prospective, randomized trial where patients will be randomly assigned to 1 of 3 groups, each with a sample size of 25 (total n=75). Group 1 will receive DEXYCU + Omidria (Omidria = ketorolac + phenylephrine), group 2 will receive DEXTENZA + Omidria, and group 3 will receive prednisolone acetate + Omidria. Each of the drug combinations used in each of the 3 groups is standard of care, FDA approved, and will be used on label. 1:1:1, n=75 with 25 subjects assigned to each of the 3 groups.

Conditions

• Cataract Surgery

Interventions

Type	Name	Description
DRUG	Omidria	phenylephrine 1% and ketorolac 0.3% intraocular solution
DRUG	Dextenza (dexamethasone ophthalmic insert) 0.4mg	intracanalicular dexamethasone insert
DRUG	Dexycu, 9% Intraocular Suspension	dexamethasone intraocular suspension
DRUG	Prednisolone Acetate 1%	standard postoperative ophthalmic drop regimen

Timeline

• Start date: 2019-12-10
• Primary completion: 2020-12-23
• Completion: 2020-12-23
• First posted: 2020-03-20
• Last updated: 2023-06-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study