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

Sponsor

Edward J. Holland (Other)

Overall Status

Completed

CT.gov ID

NCT01244334

Collaborator

Sirion Therapeutics, Inc. (Industry), Alcon Research (Industry), Parsons Medical Communications (Other)

Enrollment

Locations

Arms

Duration (Months)

17.3

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cataracts Corneal Edema Retinal Structural Change, Deposit and Degeneration Visual Acuity Reduced Transiently	Drug: Difluprednate ophthalmic emulsion 0.05% Drug: Prednisolone acetate 1%	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Mar 1, 2009

Actual Primary Completion Date :

Jun 1, 2010

Actual Study Completion Date :

Nov 1, 2010

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Assess change from Baseline on 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

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]

Other Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cincinnati Eye Institute	Edgewood	Kentucky	United States	41017
2	Ophthalmic Consultants of Long Island	Lynbrook	New York	United States	11563
3	Carolina Eyecare	Mt Pleasant	South Carolina	United States	29464

Sponsors and Collaborators

Edward J. Holland
Sirion Therapeutics, Inc.
Alcon Research
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