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

This study has been completed.
Sponsor:
Collaborators:
Sirion Therapeutics, Inc.
Alcon Research
Parsons Medical Communications
Information provided by (Responsible Party):
Edward J. Holland, Cincinnati Eye Institute Northern Kentucky
ClinicalTrials.gov Identifier:
NCT01244334
First received: November 18, 2010
Last updated: August 6, 2012
Last verified: August 2012
History of Changes
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:

MedlinePlus related topics: Cataract Edema
U.S. FDA Resources

Further study details as provided by Cincinnati Eye Institute Northern Kentucky:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: March 2009
Study Completion Date: November 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Prednisolone acetate

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01244334

Locations
United States, Kentucky
Cincinnati Eye Institute
Edgewood, Kentucky, United States, 41017
United States, New York
Ophthalmic Consultants of Long Island
Lynbrook, New York, United States, 11563
United States, South Carolina
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
  More Information

No publications provided by Cincinnati Eye Institute Northern Kentucky

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Edward J. Holland, Sponsor Investigator, Cincinnati Eye Institute Northern Kentucky
ClinicalTrials.gov Identifier: NCT01244334     History of Changes
Other Study ID Numbers: SEMC 5/2009-011
Study First Received: November 18, 2010
Last Updated: August 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Cincinnati Eye Institute Northern Kentucky:
cataract surgery, vision, corneal edema, retinal thickness

Additional relevant MeSH terms:
Corneal Edema
Edema
Cataract
Corneal Diseases
Eye Diseases
Signs and Symptoms
Lens Diseases
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Fluprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
 Difluprednate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 23, 2013