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

Phase 4

• Conditions: Pseudophakia; Cataract Surgery
• Interventions: Drug: Pred Forte; Drug: Lotemax

• Registration Number: NCT01193504
• Lead Sponsor: Innovative Medical

Brief 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.

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.

Study Timeline

• Study First Submitted: 2010-08-31
• Study Start: 2010-09
• Study First Submitted QC: 2010-09-01
• Study First Posted: 2010-09-02
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-13
• Last Update Posted: 2012-06-14
• Primary Completion: 2012-10
• Study Completion: 2012-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pred Forte	Pred Forte	Patients scheduled to undergo phacoemulsification will be randomized in a 1:1 schedule to receive Pred Forte BID for 4 weeks postop. All patients will receive Xibrom BID for one month and Besifloxacin BID for 7 to 10 days postop.
Lotemax	Lotemax	patients scheduled to undergo phacoemulsification will be randomized in a 1:1 schedule to receive Lotemax BID for 4 weeks postop. All patients will receive Xibrom BID for one month and Besifloxacin BID for 7 to 10 days postop.

Primary Outcome Measures

Name	Time	Method
Prevention Of Retinal Thickening	1 Year	* OCT (optical coherence tomography) with macular thickening; * Incidence of CME ( cystoids macular edema); * BCVA (best corrected visual acuity); * UCVA (uncorrected visual acuity); * Central corneal thickness

Trial Locations

Locations (3)

Harvard Eye Associates; 🇺🇸 Laguna Hills, California, United States

The Center For Excellence in Eye care; 🇺🇸 Miami, Florida, United States

Ophthalmic Consultants of Boston; 🇺🇸 Waltham, Massachusetts, United States