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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01193504
• Date of registration: 31/08/2010
• Primary sponsor: Innovative Medical
• Public 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
• Scientific 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
• Date of first enrolment: September 2010
• Target sample size: 100
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01193504
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Countries of recruitment

United States

Contacts

• Name: Jenna Piel

• Name: John Hovanesian, MD
• Affiliation: Harvard Eye Associates

• Name: Bonnie Henderson, MD
• Affiliation: Ophthalmic Consultants of Boston

• Name: William Trattler, MD
• Affiliation: The Center for Excellence in Eye Care

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Cataract Surgery

Pseudophakia

Intervention(s)

Drug: Lotemax

Drug: Pred Forte

Primary Outcome(s)

Prevention Of Retinal Thickening [Time Frame: 1 Year]

Secondary ID(s)

25324

Source(s) of Monetary Support

Please refer to primary and secondary sponsors