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

Silverstein Eye Centers

Status and phase: Completed; Phase 4

Conditions: Cataract Surgery

Treatments: Drug: Dextenza (dexamethasone ophthalmic insert) 0.4mg; Drug: Prednisolone Acetate 1%; Drug: Dexycu, 9% Intraocular Suspension; Drug: Omidria

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04316936

1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 3 patient groups

Omidria + Dextenza (dexamethasone ophthalmic insert) 0.4mg

Experimental group

Description:

Omidria (= ketorolac + phenylephrine) and intracanalicular dexamethasone insert (punctal plug)

Treatment:

Drug: Omidria

Drug: Dextenza (dexamethasone ophthalmic insert) 0.4mg

Omidria + Dexycu

Experimental group

Description:

Omidria (= ketorolac + phenylephrine) and intraocular dexamethasone suspension

Treatment:

Drug: Omidria

Drug: Dexycu, 9% Intraocular Suspension

Omidria + Prednisolone Acetate 1%

Active Comparator group

Description:

Omidria (= ketorolac + phenylephrine) and topical prednisolone acetate ophthalmic drops

Treatment:

Drug: Omidria

Drug: Prednisolone Acetate 1%