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

August 6, 2012 updated by: Edward J. Holland

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • Cincinnati Eye Institute
    • New York
      • Lynbrook, New York, United States, 11563
        • Ophthalmic Consultants of Long Island
    • South Carolina
      • Mt Pleasant, South Carolina, United States, 29464
        • Carolina Eyecare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.
  • Presence of glaucoma.
  • Any confirmed or suspected active viral, bacterial, or fungal keratoconjunctival disease.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Difluprednate Ophthalmic Emulsion 0.05%
Drug: Difluprednate ophthalmic emulsion 0.05%
Difluprednate ophthalmic emulsion 0.05%: 29 days total, total of 7 drops prior to surgery, and 3 more following surgery while at the surgery center, then Q2H on day of surgery, then QID for 1 week, then BID for 1 week, then stop.
Other Names:
  • Durezol
Active Comparator: Prednisolone acetate suspension 0.1%
Drug: Prednisolone acetate 1%
Prednisolone acetate 1% : 29 days total, total of 7 drops prior to surgery, and 3 more following surgery while at the surgery center, then Q2H on day of surgery, then QID for 1 week, then BID for 1 week, then stop.
Other Names:
  • Prednisolone acetate

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Assess change from Baseline on visual acuity, corneal edema, and retinal thickness at Day 15
Time Frame: 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

Other Outcome Measures

Outcome Measure
Time Frame
change from Baseline on visual acuity, corneal edema, and retinal thickness at Day 30
Time Frame: change from Baseline on visual acuity, corneal edema, and retinal thickness at Day 30
change from Baseline on visual acuity, corneal edema, and retinal thickness at Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Edward J. Holland

Collaborators

Alcon Research
Sirion Therapeutics, Inc.
Parsons Medical Communications

Investigators

  • Principal Investigator: Edward J Holland, MD, Cincinnati Eye Institute
  • Principal Investigator: Eric D Donnenfeld, MD, Ophthalmic Consultants of Long Island
  • Principal Investigator: Kerry S Solomon, MD, Carolina Eyecare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

November 18, 2010

First Submitted That Met QC Criteria

November 18, 2010

First Posted (Estimate)

November 19, 2010

Study Record Updates

Last Update Posted (Estimate)

August 8, 2012

Last Update Submitted That Met QC Criteria

August 6, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SEMC 5/2009-011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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