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

Primary Purpose

Cataracts, Corneal Edema, Retinal Structural Change, Deposit and Degeneration

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Difluprednate ophthalmic emulsion 0.05%
Prednisolone acetate 1%
Sponsored by
Edward J. Holland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataracts focused on measuring cataract surgery, vision, corneal edema, retinal thickness

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Cincinnati Eye Institute
  • Ophthalmic Consultants of Long Island
  • Carolina Eyecare

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Difluprednate Ophthalmic Emulsion 0.05%

Prednisolone acetate suspension 0.1%

Arm Description

Outcomes

Primary Outcome Measures

Assess change from Baseline on 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

Full Information

First Posted
November 18, 2010
Last Updated
August 6, 2012
Sponsor
Edward J. Holland
Collaborators
Sirion Therapeutics, Inc., Alcon Research, Parsons Medical Communications
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1. Study Identification

Unique Protocol Identification Number
NCT01244334
Brief Title
Study of Difluprednate vs. Prednisolone Acetate on Visual Acuity, and Corneal Edema Following Cataract Surgery.
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 Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Edward J. Holland
Collaborators
Sirion Therapeutics, Inc., Alcon Research, Parsons Medical Communications

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataracts, Corneal Edema, Retinal Structural Change, Deposit and Degeneration, Visual Acuity Reduced Transiently
Keywords
cataract surgery, vision, corneal edema, retinal thickness

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Difluprednate Ophthalmic Emulsion 0.05%
Arm Type
Active Comparator
Arm Title
Prednisolone acetate suspension 0.1%
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Difluprednate ophthalmic emulsion 0.05%
Other Intervention Name(s)
Durezol
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Prednisolone acetate 1%
Other Intervention Name(s)
Prednisolone acetate
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Other Pre-specified Outcome Measures:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward J Holland, MD
Organizational Affiliation
Cincinnati Eye Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric D Donnenfeld, MD
Organizational Affiliation
Ophthalmic Consultants of Long Island
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kerry S Solomon, MD
Organizational Affiliation
Carolina Eyecare
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Eye Institute
City
Edgewood
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
Ophthalmic Consultants of Long Island
City
Lynbrook
State/Province
New York
ZIP/Postal Code
11563
Country
United States
Facility Name
Carolina Eyecare
City
Mt Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21704965
Citation
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.
Results Reference
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Study of Difluprednate vs. Prednisolone Acetate on Visual Acuity, and Corneal Edema Following Cataract Surgery.

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