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

Sponsor

Innovative Medical (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01193504

Collaborator

(none)

100

Enrollment

Locations

Arms

Duration (Months)

33.3

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pseudophakia Cataract Surgery	Drug: Pred Forte Drug: Lotemax	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Prevention

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 Start Date :

Sep 1, 2010

Anticipated Primary Completion Date :

Oct 1, 2012

Anticipated Study Completion Date :

Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: Pred Forte Pred Forte BID for 4 weeks postop
Active Comparator: 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.	Drug: Lotemax Lotemax BID for 4 weeks postop.

Arm

Intervention/Treatment

Active Comparator: 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.

Drug: Pred Forte

Pred Forte BID for 4 weeks postop

Active Comparator: 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.

Drug: Lotemax

Lotemax BID for 4 weeks postop.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Harvard Eye Associates	Laguna Hills	California	United States	92653
2	The Center For Excellence in Eye care	Miami	Florida	United States	33176
3	Ophthalmic Consultants of Boston	Waltham	Massachusetts	United States	02451

Sponsors and Collaborators

Innovative Medical

Investigators

Principal Investigator: William Trattler, MD, The Center for Excellence in Eye Care
Principal Investigator: John Hovanesian, MD, Harvard Eye Associates
Principal Investigator: Bonnie Henderson, MD, Ophthalmic Consultants of Boston