NCT00501579

Brief Summary

The purpose of this study is to determine the safety and efficacy of difluprednate compared with prednisolone acetate in the treatment of endogenous anterior uveitis.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 16, 2007

Completed
Last Updated

August 29, 2008

Status Verified

August 1, 2008

First QC Date

July 13, 2007

Last Update Submit

August 27, 2008

Conditions

Uveitis

Interventions

DifluprednateDRUG
Prednisolone AcetateDRUG

Eligibility Criteria

Age2 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of endogenous anterior uveitis in at least 1 eye

You may not qualify if:

  • Presence of intermediate uveitis, posterior uveitis or panuveitis
  • Corneal abrasion
  • Any confirmed or suspected active viral, bacterial, or fungal keratoconjunctival disease
  • Allergy to similar drugs, such as other corticosteroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

John-Kenyon American Eye Institute

New Albany, Indiana, 47150, United States

Location

Related Publications (1)

  • Foster CS, Davanzo R, Flynn TE, McLeod K, Vogel R, Crockett RS. Durezol (Difluprednate Ophthalmic Emulsion 0.05%) compared with Pred Forte 1% ophthalmic suspension in the treatment of endogenous anterior uveitis. J Ocul Pharmacol Ther. 2010 Oct;26(5):475-83. doi: 10.1089/jop.2010.0059.

    PMID: 20809807DERIVED

MeSH Terms

Conditions

Uveitis

Interventions

difluprednateprednisolone acetate

Condition Hierarchy (Ancestors)

Uveal DiseasesEye Diseases

Study Officials

  • Roger Vogel, MD

    Sirion Therapeutics

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 13, 2007

First Posted

July 16, 2007

Last Updated

August 29, 2008

Record last verified: 2008-08

Locations

US(1)