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
3
Locations
2
Arms
25
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 DiseaseIntervention/TreatmentPhase
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

ArmIntervention/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

  1. 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

SiteCityStateCountryPostal Code
1Harvard Eye AssociatesLaguna HillsCaliforniaUnited States92653
2The Center For Excellence in Eye careMiamiFloridaUnited States33176
3Ophthalmic Consultants of BostonWalthamMassachusettsUnited States02451

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01193504
Other Study ID Numbers:
  • 25324
First Posted:
Sep 2, 2010
Last Update Posted:
Jun 14, 2012
Last Verified:
Jun 1, 2012

Study Results

No Results Posted as of Jun 14, 2012