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

S

Sirion Therapeutics

Status and phase

Completed
Phase 3

Conditions

Inflammation

Treatments

Drug: Difluprednate
Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00616993
ST-601-004

Details and patient eligibility

About

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

Enrollment

120 estimated patients

Sex

All

Ages

2+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

120 participants in 2 patient groups, including a placebo group

2
Placebo Comparator group
Description:
Vehicle
Treatment:
Other: Placebo
1
Experimental group
Description:
Difluprednate
Treatment:
Drug: Difluprednate

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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