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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified June 2012 by Innovative Medical.
Recruitment status was: Recruiting

Sponsor:

Information provided by:

Innovative Medical

ClinicalTrials.gov Identifier:

NCT01193504

First received: August 31, 2010

Last updated: June 13, 2012

Last verified: June 2012

History of Changes

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 (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:

MedlinePlus related topics: Cataract

Drug Information available for: Prednisolone Prednisolone acetate Methylprednisolone acetate Methylprednisolone Prednisolone sodium phosphate Prednisolone phosphate Prednisolone sodium succinate Methylprednisolone sodium succinate Loteprednol etabonate Bromfenac sodium Bromfenac Besifloxacin

U.S. FDA Resources

Further study details as provided by Innovative Medical:

Primary Outcome Measures:

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


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 (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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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

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

ClinicalTrials.gov processed this record on August 17, 2017

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