A Randomized, Masked Multi-center Safety & Efficacy Study of the Effects of Preoperative & Postoperative Cataract Surgery Use of Difluprednate Ophthalmic Emulsion, 0.05% Compared to Prednisolone Acetate Ophthalmic Suspension 1% on Visual Acuity & Corneal Edema.

Edward J. Holland3 sites in 1 country52 target enrollmentMarch 2009

ConditionsCataracts Corneal Edema Retinal Structural Change, Deposit and Degeneration Visual Acuity Reduced Transiently

InterventionsDifluprednate ophthalmic emulsion 0.05%Prednisolone acetate 1%

DrugsDifluprednate ophthalmic emulsion 0.05%Prednisolone acetate 1%

Overview

Phase: Phase 4
Intervention: Difluprednate ophthalmic emulsion 0.05%
Conditions: Cataracts
Sponsor: Edward J. Holland
Enrollment: 52
Locations: 3
Primary Endpoint: Assess change from Baseline on visual acuity, corneal edema, and retinal thickness at Day 1
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this clinical research study is to investigate the efficacy of predosing patients undergoing cataract surgery with the potent corticosteroid difluprednate ophthalmic emulsion 0.05% compared to prednisolone acetate 1% on corneal edema (swelling), and retinal thickness.

Registry

clinicaltrials.gov

Start Date

March 2009

End Date

November 2010

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Edward J. Holland

Responsible Party

Sponsor Investigator

Principal Investigator

Edward J. Holland

Sponsor Investigator

Cincinnati Eye Institute Northern Kentucky

Eligibility Criteria

Inclusion Criteria

•Healthy male or female 21 years of age or older
•Scheduled to undergo standard cataract surgery with topical anesthesia in both eyes within 6-25 days between surgeries.
•Willing and able to administer eye drops and record the times the drops were instilled
•Understand and are willing to sign the Informed Consent form
•Willing to complete the entire course of the study.

Exclusion Criteria

•Use of an eye medication or drops within 48 hours of the scheduled cataract surgery, other than the study medication or procedural solution required for surgery.
•Known sensitivity to any of the ingredients in the study medications or similar medications.
•Scheduled for 2nd eye cataract surgery earlier than 6 days or longer than 25 days apart.
•Corneal edema in either eye.
•Need for regional or general anesthesia during surgery.
•Complicated cataract surgery, including use of iris hooks or iris stretchers.
•Sight better than 20/100 in only one eye.
•A history of previous intraocular surgery in either eye.
•A history of uveitis, iritis, or intraocular inflammation.
•Macular pathology of the retina.

Arms & Interventions

Difluprednate Ophthalmic Emulsion 0.05%

Intervention: Difluprednate ophthalmic emulsion 0.05%

Prednisolone acetate suspension 0.1%

Intervention: Prednisolone acetate 1%

Outcomes

Primary Outcomes

Assess change from Baseline on visual acuity, corneal edema, and retinal thickness at Day 1

Time Frame: Change from Baseline in visual acuity, corneal edema, and retinal thickness at Day 1

Secondary Outcomes

Assess change from Baseline on visual acuity, corneal edema, and retinal thickness at Day 15(change from Baseline on visual acuity, corneal edema, and retinal thickness at Day 15)