NCT00616993

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2008

Shorter than P25 for phase_3

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

Study Start

First participant enrolled

January 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 4, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 15, 2008

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

July 1, 2011

Status Verified

June 1, 2011

Enrollment Period

2 months

First QC Date

February 4, 2008

Last Update Submit

June 29, 2011

Conditions

Inflammation

Outcome Measures

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.

    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.

    Day 7

Study Arms (2)

2

PLACEBO COMPARATOR

Vehicle

Other: Placebo

1

EXPERIMENTAL

Difluprednate

Drug: Difluprednate

Interventions

DifluprednateDRUG

Difluprednate

1
PlaceboOTHER

Vehicle

2

Eligibility Criteria

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

You may qualify if:

  • Scheduled for unilateral ocular surgery.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye Associates of Fort Myers

Fort Myers, Florida, 33901, United States

Location

MeSH Terms

Conditions

Inflammation

Interventions

difluprednate

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Roger Vogel, MD

    Sirion Therapeutics

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 4, 2008

First Posted

February 15, 2008

Study Start

January 1, 2008

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

July 1, 2011

Record last verified: 2011-06

Locations

US(1)