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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

NCT01193504 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2012-06-14

No results posted yet for this study

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

Interventions

DRUG

Pred Forte

Pred Forte BID for 4 weeks postop

DRUG

Lotemax

Lotemax BID for 4 weeks postop.

Sponsors & Collaborators

  • Innovative Medical

    lead INDUSTRY

Principal Investigators

  • William Trattler, MD · The Center for Excellence in Eye Care

  • John Hovanesian, MD · Harvard Eye Associates

  • Bonnie Henderson, MD · Ophthalmic Consultants of Boston

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01193504 on ClinicalTrials.gov