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Study of Difluprednate vs. Prednisolone Acetate on Visual Acuity, and Corneal Edema Following Cataract Surgery.

Information source: Cincinnati Eye Institute Northern Kentucky
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cataracts; Corneal Edema; Retinal Structural Change, Deposit and Degeneration; Visual Acuity Reduced Transiently

Intervention: Difluprednate ophthalmic emulsion 0.05% (Drug); Prednisolone acetate 1% (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Edward J. Holland

Official(s) and/or principal investigator(s):
Edward J Holland, MD, Principal Investigator, Affiliation: Cincinnati Eye Institute
Eric D Donnenfeld, MD, Principal Investigator, Affiliation: Ophthalmic Consultants of Long Island
Kerry S Solomon, MD, Principal Investigator, Affiliation: Carolina Eyecare


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.

Clinical Details

Official title: 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.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

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

Secondary outcome: Assess change from Baseline on visual acuity, corneal edema, and retinal thickness at Day 15


Minimum age: 21 Years. Maximum age: N/A. Gender(s): Both.


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


- 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


- Scheduled for 2nd eye cataract surgery earlier than 6 days or longer than 25 days


- 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.

- Presence of glaucoma.

- Any confirmed or suspected active viral, bacterial, or fungal keratoconjunctival


- History of steroid-related intraocular pressure (IOP) rise in the study eye.

- Lack of an intact corneal epithelium.

- Pupils that do not dilate to more than 5 mm prior to surgery or you require

mechanical stretching of your pupil.

- Diabetes mellitus.

- Required use of a systemic steroidal or non-steroidal anti-inflammatory during the

study period.

- Doctor has determined the presence of a condition (i. e., UNCONTROLLED systemic

disease) or a situation that may put the subject at significant risk, confound the study results or may interfere significantly with your participation in the study.

- Females, who are pregnant, nursing an infant or planning a pregnancy.

- Currently involved in another investigational study or have participated in one

within the 30 days prior to entering this study.

- Unable or unwilling to give signed informed consent prior to participation in any

study-related procedures.

Locations and Contacts

Cincinnati Eye Institute, Edgewood, Kentucky 41017, United States

Ophthalmic Consultants of Long Island, Lynbrook, New York 11563, United States

Carolina Eyecare, Mt Pleasant, South Carolina 29464, United States

Additional Information

Starting date: March 2009
Last updated: August 6, 2012

Page last updated: August 23, 2015

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