Clinical trial NCT00407056: Study of Difluprednate Ophthalmic Emulsion in the Treatment of Severe Uveitis
Official title: Phase 3 Open-Labeled Study of 0.05% Difluprednate Ophthalmic Emulsion in the Treatment of Severe Anterior Uveitis (Including Panuveitis).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Uveitis
Panuveitis
Lead sponsor: Sirion Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2006-12-04
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The anterior chamber cell score was compared between baseline and Day 14.
Secondary outcomes:
measure: The anterior chamber cell score was compared between baseline and Days 3 and 7.
measure: The total symptom score (sum of eye pain, photophobia, blurred
measure: vision, foreign body sensation and lacrimation scores) and total
measure: sign score (sum of anterior chamber cell, anterior chamber flare,
measure: ciliary hyperemia, keratic precipitate and synechia of iris and
measure: posterior scores) were compared between baseline and Days 3, 7
measure: and 14.
Other outcomes:
Locations:
Study officials:
affiliation: Department of Ophthalmology and Visual Science, Graduate School of Medicine, Hokkaido University
name: Shigeaki Ono
role: PRINCIPAL_INVESTIGATOR
References: