Status:
COMPLETED
Study of Difluprednate vs. Prednisolone Acetate on Visual Acuity, and Corneal Edema Following Cataract Surgery.
Lead Sponsor:
Edward J. Holland
Collaborating Sponsors:
Sirion Therapeutics, Inc.
Alcon Research
Conditions:
Cataracts
Corneal Edema
Eligibility:
All Genders
21+ years
Phase:
PHASE4
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% comp...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT01244334
Start Date
March 1 2009
End Date
November 1 2010
Last Update
August 8 2012
Active Locations (3)
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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