Study of Difluprednate Ophthalmic Emulsion in the Treatment of Severe Uveitis

Sirion Therapeutics

Status and phase

Completed

Phase 3

Conditions

Uveitis

Panuveitis

Treatments

Drug: Difluprednate Ophthalmic Emulsion

Study type

Interventional

Funder types

Industry

Identifiers

NCT00407056

SJE2079/3-02-PC

Details and patient eligibility

About

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

Full description

The objective of this phase 3 study is to assess the efficacy and safety of 0.05% difluprednate ophthalmic emulsion in patients with severe endogenous anterior uveitis with an open-labeled, no-controlled and no-randomized design.

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with a diagnosis of endogenous anterior uveitis or panuveitis
Patients with ≥ 50 anterior chamber cells as observed by slit lamp microscopy (criterion for evaluation of signs 4)
Patients requiring more frequent instillation of 0.1% betamethasone sodium phosphate ophthalmic solution than the regular frequency specified in its dosage and administration (3 - 4 times/day)
Patients aged ≥ 12 years (on the day of obtaining informed consent) who were able to actuate symptoms
Patients giving written informed consent prior to initiation of the study

Exclusion criteria

Patients who did not meet all of the above inclusion criteria
Patients initiating treatment with systemic administration of any corticosteroid, non-steroidal anti-inflammatory drug, antiphlogistic enzyme or immunosuppressive drug within 2 weeks before instillation of the investigational drug
Patients receiving topical injection of any corticosteroid in eyes before instillation of the investigational product(solution formulation: within 1 week before instillation of the investigational product, depot formulation: within 2 weeks before instillation of the investigational product)
Patients receiving instillation of any corticosteroid, non-steroidal anti-inflammatory ophthalmic solution or antiphologistic enzyme within 12 hours before instillation of the investigational drug
Patients with glaucoma or ocular hypertension
Patients with corneal erosion or corneal ulcer
Patients with any viral, bacterial or fungal keratoconjunctival disease or suspected with eye infection
Patients with allergy to similar drugs of difluprednate
Patients requiring use of contact lens during the study period
Women who were or might be pregnant, or lactating women
Patients participating in another clinical study within 3 months before initiation of the present study