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

Last updated: June 13, 2023
Sponsor: Silverstein Eye Centers
Overall Status: Completed

Phase

4

Condition

Eye Disease

Vision Loss

Eye Disorders/infections

Treatment

Dexycu, 9% Intraocular Suspension

Dextenza (dexamethasone ophthalmic insert) 0.4mg

Omidria

Clinical Study ID

NCT04316936
1
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 canbe done at the time of cataract surgery (e.g., stent placement, endo-laser, etc.), butfemto-second laser-assisted surgery is permitted.

Study Design

Total Participants: 15
Treatment Group(s): 4
Primary Treatment: Dexycu, 9% Intraocular Suspension
Phase: 4
Study Start date:
December 10, 2019
Estimated Completion Date:
December 23, 2020

Study 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.

Connect with a study center

  • Silverstein Eye Centers

    Kansas City, Missouri 64133
    United States

    Site Not Available

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