Study of Difluprednate vs. Prednisolone Acetate on Visual Acuity, and Corneal Edema Following Cataract Surgery.
Information source: Cincinnati Eye Institute Northern Kentucky
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cataracts; Corneal Edema; Retinal Structural Change, Deposit and Degeneration; Visual Acuity Reduced Transiently
Intervention: Difluprednate ophthalmic emulsion 0.05% (Drug); Prednisolone acetate 1% (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Edward J. Holland Official(s) and/or principal investigator(s):
Edward J Holland, MD, Principal Investigator, Affiliation: Cincinnati Eye Institute
Eric D Donnenfeld, MD, Principal Investigator, Affiliation: Ophthalmic Consultants of Long Island
Kerry S Solomon, MD, Principal Investigator, Affiliation: Carolina Eyecare
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Assess change from Baseline on visual acuity, corneal edema, and retinal thickness at Day 1
Secondary outcome: Assess change from Baseline on visual acuity, corneal edema, and retinal thickness at Day 15
Eligibility
Minimum age: 21 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Cincinnati Eye Institute, Edgewood, Kentucky 41017, United States
Ophthalmic Consultants of Long Island, Lynbrook, New York 11563, United States
Carolina Eyecare, Mt Pleasant, South Carolina 29464, United States
Additional Information
Starting date: March 2009
Last updated: August 6, 2012
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