Recruiting

Bromfenac & Besifloxacin

Sponsor:

Innovative Medical

Code:

NCT01193504

Conditions

Pseudophakia

Cataract Surgery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Pred Forte

Lotemax

Study Details

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.

Conditions

Pseudophakia

Cataract Surgery

Study ID

NCT01193504

Start date

Sep, 2010

Status verified date

Jun, 2012

Completion date

Oct, 2012

Anticipated

Primary completion date

Oct, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Pred Forte

Pred Forte BID for 4 weeks postop

Lotemax

Lotemax BID for 4 weeks postop.

Primary outcome measure

  • Prevention Of Retinal Thickening [ Time Frame: 1 Year ]

Central Contacts and Locations

Central contacts

Jenna Piel

(951)653-5566j.piel@imedsonline.com

Locations

Harvard Eye Associates

Recruiting

Laguna Hills, California, United States, 92653

Contacts

Melissa Earl

951-653-5566m.earl@imedsonline.com

Annie Christensen

(951)653-5566a.christensen@imedsonline.com

Principal Investigator:

John Hovanesian, MD

The Center For Excellence in Eye care

Recruiting

Miami, Florida, United States, 33176

Contacts

Melissa Earl

951-653-5566m.earl@imedsonline.com

Annie Christensen

(951)653-5566a.christensen@imedsonline.com

Principal Investigator:

William Trattler, MD

More Information

Sponsor

Innovative Medical

Last update posted

Jun 14, 2012

Last verified

Jun, 2012

Keywords

  • Prevention of Retinal Thickening and CME Following Phacoemulsification
  • Pseudophakia following cataract surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Innovative Medical on 2012-06-14.