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Study of Difluprednate vs. Prednisolone Acetate on Visual Acuity, and Corneal Edema Following Cataract Surgery.

NCT01244334 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2012-08-08

No results posted yet for this study

Summary

The purpose of this clinical research study is to investigate the efficacy of predosing patients undergoing cataract surgery with the potent corticosteroid difluprednate ophthalmic emulsion 0.05% compared to prednisolone acetate 1% on corneal edema (swelling), and retinal thickness.

Conditions

  • Cataracts
  • Corneal Edema
  • Retinal Structural Change, Deposit and Degeneration
  • Visual Acuity Reduced Transiently

Interventions

DRUG

Difluprednate ophthalmic emulsion 0.05%

Difluprednate ophthalmic emulsion 0.05%: 29 days total, total of 7 drops prior to surgery, and 3 more following surgery while at the surgery center, then Q2H on day of surgery, then QID for 1 week, then BID for 1 week, then stop.

DRUG

Prednisolone acetate 1%

Prednisolone acetate 1% : 29 days total, total of 7 drops prior to surgery, and 3 more following surgery while at the surgery center, then Q2H on day of surgery, then QID for 1 week, then BID for 1 week, then stop.

Sponsors & Collaborators

  • Sirion Therapeutics, Inc.

    collaborator INDUSTRY

  • Alcon Research

    collaborator INDUSTRY

  • Parsons Medical Communications

    collaborator UNKNOWN

  • Edward J. Holland

    lead OTHER

Principal Investigators

  • Edward J Holland, MD · Cincinnati Eye Institute

  • Eric D Donnenfeld, MD · Ophthalmic Consultants of Long Island

  • Kerry S Solomon, MD · Carolina Eyecare

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2010-06-30
Completion
2010-11-30

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 NCT01244334 on ClinicalTrials.gov