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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

Primary Purpose

Pseudophakia, Cataract Surgery

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Pred Forte
Lotemax
Sponsored by
Innovative Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pseudophakia focused on measuring Prevention of Retinal Thickening and CME Following Phacoemulsification, Pseudophakia following cataract surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Harvard Eye AssociatesRecruiting
  • The Center For Excellence in Eye careRecruiting
  • Ophthalmic Consultants of Boston

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Pred Forte

Lotemax

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Prevention Of Retinal Thickening
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

Secondary Outcome Measures

Full Information

First Posted
August 31, 2010
Last Updated
June 13, 2012
Sponsor
Innovative Medical
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1. Study Identification

Unique Protocol Identification Number
NCT01193504
Brief 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
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 Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
October 2012 (Anticipated)
Study Completion Date
October 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Innovative Medical

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pseudophakia, Cataract Surgery
Keywords
Prevention of Retinal Thickening and CME Following Phacoemulsification, Pseudophakia following cataract surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pred Forte
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Lotemax
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Pred Forte
Intervention Description
Pred Forte BID for 4 weeks postop
Intervention Type
Drug
Intervention Name(s)
Lotemax
Intervention Description
Lotemax BID for 4 weeks postop.
Primary Outcome Measure Information:
Title
Prevention Of Retinal Thickening
Description
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
Time Frame
1 Year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jenna Piel
Phone
(951)653-5566
Email
j.piel@imedsonline.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Trattler, MD
Organizational Affiliation
The Center for Excellence in Eye Care
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John Hovanesian, MD
Organizational Affiliation
Harvard Eye Associates
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bonnie Henderson, MD
Organizational Affiliation
Ophthalmic Consultants of Boston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harvard Eye Associates
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Earl
Phone
951-653-5566
Email
m.earl@imedsonline.com
First Name & Middle Initial & Last Name & Degree
Annie Christensen
Phone
(951)653-5566
Email
a.christensen@imedsonline.com
First Name & Middle Initial & Last Name & Degree
John Hovanesian, MD
Facility Name
The Center For Excellence in Eye care
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Earl
Phone
951-653-5566
Email
m.earl@imedsonline.com
First Name & Middle Initial & Last Name & Degree
Annie Christensen
Phone
(951)653-5566
Email
a.christensen@imedsonline.com
First Name & Middle Initial & Last Name & Degree
William Trattler, MD
First Name & Middle Initial & Last Name & Degree
Carlos Buznego, MD
Facility Name
Ophthalmic Consultants of Boston
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02451
Country
United States
Individual Site Status
Completed

12. IPD Sharing Statement

Learn more about this trial

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

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