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

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

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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