Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis

Sirion Therapeutics

Status and phase

Completed

Phase 3

Conditions

Anterior Uveitis

Panuveitis

Treatments

Drug: Difluprednate Ophthalmic Emulsion

Study type

Interventional

Funder types

Industry

Identifiers

NCT00406887

SJE2079/3-01-PC

Details and patient eligibility

About

The purpose of this phase 3 confirmatory study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of treatment of uveitis.

Full description

The objective of this phase 3 study is to assess the efficacy and safety of 0.05% difluprednate ophthalmic emulsion (DFBA) in patients with endogenous anterior uveitis, in comparison with 0.1% betamethasone sodium phosphate ophthalmic solution (BP).

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients diagnosed with endogenous anterior uveitis or panuveitis
Patients with 10 - 49 anterior chamber cells within one field of the anterior chamber as observed by slit lamp microscopy (criterion for rating of signs 2 or 3)
Patients aged ‰1425 years (on the day of obtaining informed consent) who were able to accurately express their own symptoms
Patients provided written informed consent prior to initiation of the study

Exclusion criteria

Patients who did not meet all of the above inclusion criteria
Patients received systemic administration of any corticosteroid or immunosuppressive drug within the past 1 week prior to instillation of the investigational product
Patients received topical injection of any corticosteroid in eyes prior to instillation of the investigational product (Solution formulation: within the past 1 week, depot: within the past 2 weeks)
Patients received systemic administration of any non-steroidal anti-inflammatory drug or antiphlogistic enzyme within the past 3 days prior to instillation of the investigational product
Patients received instillation of any corticosteroid, non-steroidal anti-inflammatory drug or antiphlogistic enzyme within 12 hours prior to instillation of the investigational product
Patients with glaucoma or ocular hypertension
Patients with corneal abrasion or ulcer
Patients with any confirmed or suspected viral, bacterial or fungal keratoconjunctival disease
Patients with allergy to similar drugs such as other corticosteroids
Patients requiring use of contact lens during the study period
Women who are or might be pregnant, or lactating women
Patients participating in another clinical study within the past 3 months before initiation of the present study