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

Phase 4

Completed

• Conditions: Cataract Surgery
• Interventions: Drug: Omidria; Drug: Dextenza (dexamethasone ophthalmic insert) 0.4mg; Drug: Dexycu, 9% Intraocular Suspension; Drug: Prednisolone Acetate 1%

• Registration Number: NCT04316936
• Lead Sponsor: Silverstein Eye Centers

Brief 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.

Study Timeline

• Study Start: 2019-12-10
• Study First Submitted: 2020-03-17
• Study First Submitted QC: 2020-03-18
• Study First Posted: 2020-03-20
• Primary Completion: 2020-12-23
• Study Completion: 2020-12-23
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-13
• Last Update Posted: 2023-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Patients 18 years of age or older, undergoing routine, uncomplicated cataract surgery.

Exclusion Criteria

• Any history of corneal dystrophy, corneal surgery within 6 months of cataract surgery, previous intraocular surgery, any concomitant eye drop use besides artificial tears, previous ocular trauma, or a history of treated glaucoma. No additional procedures can be done at the time of cataract surgery (e.g., stent placement, endo-laser, etc.), but femto-second laser-assisted surgery is permitted.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Omidria + Dextenza (dexamethasone ophthalmic insert) 0.4mg	Omidria	Omidria (= ketorolac + phenylephrine) and intracanalicular dexamethasone insert (punctal plug)
Omidria + Dextenza (dexamethasone ophthalmic insert) 0.4mg	Dextenza (dexamethasone ophthalmic insert) 0.4mg	Omidria (= ketorolac + phenylephrine) and intracanalicular dexamethasone insert (punctal plug)
Omidria + Dexycu	Omidria	Omidria (= ketorolac + phenylephrine) and intraocular dexamethasone suspension
Omidria + Dexycu	Dexycu, 9% Intraocular Suspension	Omidria (= ketorolac + phenylephrine) and intraocular dexamethasone suspension
Omidria + Prednisolone Acetate 1%	Omidria	Omidria (= ketorolac + phenylephrine) and topical prednisolone acetate ophthalmic drops
Omidria + Prednisolone Acetate 1%	Prednisolone Acetate 1%	Omidria (= ketorolac + phenylephrine) and topical prednisolone acetate ophthalmic drops

Primary Outcome Measures

Name	Time	Method
Resolution of anterior chamber inflammation	Assessed at day 30 post-operatively	The primary efficacy end point is the complete resolution of anterior chamber inflammation (cell and flare). This is a non-contact, non-invasive test performed by the physician using a slit lamp. The evaluation requires less than one minute.

Secondary Outcome Measures

Name	Time	Method
Resolution of postoperative pain	Assessed at day 8 post-operatively	The secondary efficacy endpoint is the elimination of post-operative pain per a subjective, standardized scale. Post-operative pain as measured on a scale from 0-10 (ocular pain assessment).

Trial Locations

Locations (1)

Silverstein Eye Centers; 🇺🇸 Kansas City, Missouri, United States