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

Cataract Surgery Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01193504
• Other study ID #: 25324
• Status: Recruiting
• Phase: Phase 4
• First received: August 31, 2010
• Last updated: June 13, 2012
• Start date: September 2010
• Est. completion date: October 2012

Study information

• Verified date: June 2012
• Source: Innovative Medical
• Contact: Jenna Piel
• Phone: (951)653-5566
• Email: j.piel[@]imedsonline.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cataract Surgery
• Pseudophakia

Intervention

Drug:
• Pred Forte
Pred Forte BID for 4 weeks postop
• Lotemax
Lotemax BID for 4 weeks postop.

Locations

Country	Name	City	State
United States	Harvard Eye Associates	Laguna Hills	California
United States	The Center For Excellence in Eye care	Miami	Florida
United States	Ophthalmic Consultants of Boston	Waltham	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Innovative Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevention Of Retinal Thickening	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	1 Year	No