Randomized, Masked Comparison of Bromfenac and Besifloxacin BID With Either Prednisolone BID or Loteprednol 0.5% BID for Prevention of Retinal Thickening and CME Following Phacoemulsification
Information source: Innovative Medical
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pseudophakia; Cataract Surgery
Intervention: Pred Forte (Drug); Lotemax (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Innovative Medical Official(s) and/or principal investigator(s):
William Trattler, MD, Principal Investigator, Affiliation: The Center for Excellence in Eye Care
John Hovanesian, MD, Principal Investigator, Affiliation: Harvard Eye Associates
Bonnie Henderson, MD, Principal Investigator, Affiliation: Ophthalmic Consultants of Boston
Overall contact:
Jenna Piel, Phone: (951)653-5566, Email: j.piel@imedsonline.com
Summary
The purpose of this study is to determine if Lotemax eye drops are at least as effective as
Pred Forte eye drops, which are the standard of care after cataract surgery.
Clinical Details
Official title: Randomized, Masked Comparison of Bromfenac and Besifloxacin BID With Either Prednisolone BID or Loteprednol 0.5% BID for Prevention of Retinal Thickening and CME Following Phacoemulsification
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention
Primary outcome: Prevention Of Retinal Thickening
Detailed description:
Prednisolone 1%, a topical steroid, is considered standard of care following cataract
surgery to reduce inflammation. We aim to determine if Lotemax is at least as effective as
Prednisolone. If so, these findings would demonstrate that physicians have other treatment
options to consider.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male or female >18 years of age scheduled to undergo cataract surgery
- Patients with systemic diseases will be enrolled only if there are no ocular
manifestations of their disease (e. g. diabetics with normal retinal exams)
- Expected visual outcome of BCVA (best corrected visual acuity)> 20/25
postoperatively, as determined by potential visual acuity testing and review of
preoperative corneal topography and OCT (optical coherence tomography).
- Ability to provide informed consent, take study medications as directed, and likely
to complete all study visits
Exclusion Criteria:
- Known contraindication to any study medication or any of their components
- Required use of ocular medications other than the study medications during the study
- Evidence of macular disease (Epiretinal membrane, Vitreomacular traction syndrome,
macular hole) on preoperative OCT (optical coherence tomography)
- Presence of significant dry macular degeneration that may impact postoperative visual
results.
- History of retinal vein occlusion or diabetic macular edema, uveitis or any macular
disease predisposing them to cystoid macular edema or prolonged intraocular
inflammation.
- Posterior capsule rupture, Vitreous loss during surgery or any other complication
that in the surgeon's opinion, could reduce potential for targeted visual outcome
- Anticipated need for mechanical iris dilating devices
- Presence of Epithelial Basement Membrane Dystrophy, significant dry eye, significant
blepharitis, or any other corneal condition that may impact BCVA (best corrected
visual acuity) postoperatively
Locations and Contacts
Jenna Piel, Phone: (951)653-5566, Email: j.piel@imedsonline.com
Harvard Eye Associates, Laguna Hills, California 92653, United States; Recruiting
Melissa Earl, Phone: 951-653-5566, Email: m.earl@imedsonline.com
Annie Christensen, Phone: (951)653-5566, Email: a.christensen@imedsonline.com
John Hovanesian, MD, Principal Investigator
The Center For Excellence in Eye care, Miami, Florida 33176, United States; Recruiting
Melissa Earl, Phone: 951-653-5566, Email: m.earl@imedsonline.com
Annie Christensen, Phone: (951)653-5566, Email: a.christensen@imedsonline.com
William Trattler, MD, Principal Investigator
Carlos Buznego, MD, Sub-Investigator
Ophthalmic Consultants of Boston, Waltham, Massachusetts 02451, United States; Completed
Additional Information
Starting date: September 2010
Last updated: June 13, 2012
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