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

NCT01244334 | Completed Phase 4 DMC

• 1 other identifier: SEMC 5/2009-011
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Keywords

cataract surgery, vision, corneal edema, retinal thickness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

Difluprednate Ophthalmic Emulsion 0.05%

ACTIVE COMPARATOR

Drug: Difluprednate ophthalmic emulsion 0.05%

Prednisolone acetate suspension 0.1%

ACTIVE COMPARATOR

Drug: Prednisolone acetate 1%

Interventions

Difluprednate ophthalmic emulsion 0.05% DRUG

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.

Also known as: Durezol

Difluprednate Ophthalmic Emulsion 0.05%

Prednisolone acetate 1% DRUG

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.

Also known as: Prednisolone acetate

Prednisolone acetate suspension 0.1%

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Edward J. Holland: lead
• Sirion Therapeutics, Inc.: collaborator
• Alcon Research: collaborator
• Parsons Medical Communications: collaborator

Study Sites (3)

Cincinnati Eye Institute

Edgewood, Kentucky, 41017, United States

Location

Ophthalmic Consultants of Long Island

Lynbrook, New York, 11563, United States

Location

Carolina Eyecare

Mt. Pleasant, South Carolina, 29464, United States

Location

Related Publications (1)

• Donnenfeld ED, Holland EJ, Solomon KD, Fiore J, Gobbo A, Prince J, Sandoval HP, Shull ER, Perry HD. A multicenter randomized controlled fellow eye trial of pulse-dosed difluprednate 0.05% versus prednisolone acetate 1% in cataract surgery. Am J Ophthalmol. 2011 Oct;152(4):609-617.e1. doi: 10.1016/j.ajo.2011.03.018. Epub 2011 Jun 25.

  PMID: 21704965 DERIVED

MeSH Terms

Conditions

Cataract; Corneal Edema

Interventions

difluprednate; prednisolone acetate

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Corneal Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor Investigator

Study Record Dates

• First Submitted: November 18, 2010
• First Posted: November 19, 2010
• Study Start: March 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: November 1, 2010
• Last Updated: August 8, 2012

Record last verified: 2012-08

Locations

US (3)