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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-10

Study Completion Date

2020-12-23

Brief Summary

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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.

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Detailed Description

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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

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Cataract Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be randomly assigned to 1 of 3 groups (1:1:1), 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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Omidria + Dextenza (dexamethasone ophthalmic insert) 0.4mg

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

Group Type EXPERIMENTAL

Omidria

Intervention Type DRUG

phenylephrine 1% and ketorolac 0.3% intraocular solution

Dextenza (dexamethasone ophthalmic insert) 0.4mg

Intervention Type DRUG

intracanalicular dexamethasone insert

Omidria + Dexycu

Omidria (= ketorolac + phenylephrine) and intraocular dexamethasone suspension

Group Type EXPERIMENTAL

Omidria

Intervention Type DRUG

phenylephrine 1% and ketorolac 0.3% intraocular solution

Dexycu, 9% Intraocular Suspension

Intervention Type DRUG

dexamethasone intraocular suspension

Omidria + Prednisolone Acetate 1%

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

Group Type ACTIVE_COMPARATOR

Omidria

Intervention Type DRUG

phenylephrine 1% and ketorolac 0.3% intraocular solution

Prednisolone Acetate 1%

Intervention Type DRUG

standard postoperative ophthalmic drop regimen

Interventions

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Omidria

phenylephrine 1% and ketorolac 0.3% intraocular solution

Intervention Type DRUG

Dextenza (dexamethasone ophthalmic insert) 0.4mg

intracanalicular dexamethasone insert

Intervention Type DRUG

Dexycu, 9% Intraocular Suspension

dexamethasone intraocular suspension

Intervention Type DRUG

Prednisolone Acetate 1%

standard postoperative ophthalmic drop regimen

Intervention Type DRUG

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No