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 Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Dr. William Trattler, The Center for Excellence in Eye care
ClinicalTrials.gov Identifier:	NCT01193504 History of Changes
Other Study ID Numbers:	25324
First Posted:	September 2, 2010
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:

Cataract; Pseudophakia; Lens Diseases; Eye Diseases; Signs and Symptoms; Prednisolone acetate; Methylprednisolone acetate; Bromfenac; Prednisolone; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone hemisuccinate; Prednisolone phosphate; 7-(3-aminohexahydro-1H-azepin-1-yl)-8-chloro-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-3-quinolinecarboxylic acid; Loteprednol Etabonate	Fluoroquinolones; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Neuroprotective Agents; Protective Agents; Anti-Allergic Agents