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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

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ClinicalTrials.gov Identifier: NCT01193504
Recruitment Status : Unknown
Verified June 2012 by Innovative Medical.
Recruitment status was:  Recruiting
First Posted : September 2, 2010
Last Update Posted : June 14, 2012
Sponsor:
Information provided by:
Innovative Medical

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 2010
Estimated Primary Completion Date : October 2012
Estimated Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Prevention Of Retinal Thickening [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01193504


Contacts
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Contact: Jenna Piel (951)653-5566 j.piel@imedsonline.com

Locations
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United States, California
Harvard Eye Associates Recruiting
Laguna Hills, California, United States, 92653
Contact: Melissa Earl    951-653-5566    m.earl@imedsonline.com   
Contact: Annie Christensen    (951)653-5566    a.christensen@imedsonline.com   
Principal Investigator: John Hovanesian, MD         
United States, Florida
The Center For Excellence in Eye care Recruiting
Miami, Florida, United States, 33176
Contact: Melissa Earl    951-653-5566    m.earl@imedsonline.com   
Contact: Annie Christensen    (951)653-5566    a.christensen@imedsonline.com   
Principal Investigator: William Trattler, MD         
Sub-Investigator: Carlos Buznego, MD         
United States, Massachusetts
Ophthalmic Consultants of Boston Completed
Waltham, Massachusetts, United States, 02451
Sponsors and Collaborators
Innovative Medical
Investigators
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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
More Information
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Responsible Party: Dr. William Trattler, The Center for Excellence in Eye care
ClinicalTrials.gov Identifier: NCT01193504    
Other Study ID Numbers: 25324
First Posted: September 2, 2010    Key Record Dates
Last Update Posted: June 14, 2012
Last Verified: June 2012
Keywords provided by Innovative Medical:
Prevention of Retinal Thickening and CME Following Phacoemulsification
Pseudophakia following cataract surgery
Additional relevant MeSH terms:
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Cataract
Pseudophakia
Lens Diseases
Eye Diseases
Loteprednol Etabonate
Prednisolone acetate
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
 Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anti-Allergic Agents