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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00616993

Enrollment

120

Registered

2008-02-15

Start date

2008-01-31

Completion date

2008-03-31

Last updated

2011-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammation

Brief summary

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

Interventions

DRUGDifluprednate

Difluprednate

OTHERPlacebo

Vehicle

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

2 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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.	Day 14

Secondary

Measure	Time frame
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.	Day 7

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026