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

This study is currently recruiting participants.
Verified June 2012 by Innovative Medical
Sponsor:
Information provided by:
Innovative Medical
ClinicalTrials.gov Identifier:
NCT01193504
First received: August 31, 2010
Last updated: June 13, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Pseudophakia
Cataract Surgery
Drug: Pred Forte
Drug: Lotemax
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Innovative Medical:

Primary Outcome Measures:
  • Prevention Of Retinal Thickening [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    • 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


Estimated Enrollment: 100
Study Start Date: September 2010
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01193504

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

Locations
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
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

No publications provided

Responsible Party: Dr. William Trattler, The Center for Excellence in Eye care
ClinicalTrials.gov Identifier: NCT01193504     History of Changes
Other Study ID Numbers: 25324
Study First Received: August 31, 2010
Last Updated: June 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Innovative Medical:
Prevention of Retinal Thickening and CME Following Phacoemulsification
Pseudophakia following cataract surgery

Additional relevant MeSH terms:
Pseudophakia
Cataract
Signs and Symptoms
Lens Diseases
Eye Diseases
Methylprednisolone acetate
Prednisolone acetate
Bromfenac
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Loteprednol etabonate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on April 23, 2014