Clinical trial NCT01244334: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataracts
Corneal Edema
Retinal Structural Change, Deposit and Degeneration
Visual Acuity Reduced Transiently
Keywords: cataract surgery, vision, corneal edema, retinal thickness
Lead sponsor: Cincinnati Eye Institute Northern Kentucky
Sponsor class: OTHER
Collaborators: name: Sirion Therapeutics, Inc.
name: Alcon Research
name: Parsons Medical Communications
First posted: 2010-11-19
Enrollment: 52
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Assess change from Baseline on visual acuity, corneal edema, and retinal thickness at Day 1
timeFrame: Change from Baseline in visual acuity, corneal edema, and retinal thickness at Day 1
Secondary outcomes:
measure: Assess change from Baseline on visual acuity, corneal edema, and retinal thickness at Day 15
timeFrame: change from Baseline on visual acuity, corneal edema, and retinal thickness at Day 15
Other outcomes:
measure: change from Baseline on visual acuity, corneal edema, and retinal thickness at Day 30
timeFrame: change from Baseline on visual acuity, corneal edema, and retinal thickness at Day 30
Locations:
city: Edgewood
country: United States
facility: Cincinnati Eye Institute
state: Kentucky
city: Lynbrook
country: United States
facility: Ophthalmic Consultants of Long Island
state: New York
city: Mt Pleasant
country: United States
facility: Carolina Eyecare
state: South Carolina
Study officials:
affiliation: Cincinnati Eye Institute
name: Edward J Holland, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ophthalmic Consultants of Long Island
name: Eric D Donnenfeld, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Carolina Eyecare
name: Kerry S Solomon, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.