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

Cataracts Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01244334
• Other study ID #: SEMC 5/2009-011
• Status: Completed
• Phase: Phase 4
• First received: November 18, 2010
• Last updated: August 6, 2012
• Start date: March 2009
• Est. completion date: November 2010

Study information

• Verified date: August 2012
• Source: Cincinnati Eye Institute Northern Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: November 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Cataracts
• Corneal Edema
• Edema
• Retinal Structural Change, Deposit and Degeneration
• Visual Acuity Reduced Transiently

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Cincinnati Eye Institute	Edgewood	Kentucky
United States	Ophthalmic Consultants of Long Island	Lynbrook	New York
United States	Carolina Eyecare	Mt Pleasant	South Carolina

Sponsors (4)

Lead Sponsor	Collaborator
Edward J. Holland	Alcon Research, Parsons Medical Communications, Sirion Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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