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Completed

NCT Number: NCT00616993

Study of Difluprednate in the Treatment of Inflammation Following Ocular Surgery (ST-601-004)

The purpose of this phase III study is to determine the safety and efficacy of difluprednate in the treatment of inflammation following ocular surgery.

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Key information

Conditions

Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Eye Associates of Fort Myers

Fort Myers, Florida, 33901, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Scheduled for unilateral ocular surgery.

Exclusion criteria

  • Systemic administration of any corticosteroid or immunosuppressive drug in the 2 weeks prior to study enrollment.

Treatment and study plan

Difluprednate

Drug

Difluprednate

Placebo

Other

Vehicle

Primary outcomes

  1. The proportion of subjects with an anterior chamber cell grade of "0" and a flare grade of "0" on Day 14, compared between difluprednate and placebo groups.

    Time frame: Day 14

Secondary outcomes

  1. The proportion of subjects with an anterior chamber cell grade of "0" and a flare grade of "0" on Day 7, compared between difluprednate and placebo groups.

    Time frame: Day 7

Sponsors and collaborators

Lead sponsor

Sirion Therapeutics, Inc.

Industry

Registry information

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Feb 15, 2008
Registry last updated
Jul 1, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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