Study of Difluprednate Ophthalmic Emulsion in the Treatment of Severe Uveitis

Uveitis Clinical Trial

Official title:

Phase 3 Open-Labeled Study of 0.05% Difluprednate Ophthalmic Emulsion in the Treatment of Severe Anterior Uveitis (Including Panuveitis).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00407056
• Other study ID #: SJE2079/3-02-PC
• Status: Completed
• Phase: Phase 3
• First received: November 29, 2006
• Last updated: November 29, 2006
• Start date: August 2002
• Est. completion date: June 2003

Study information

• Verified date: November 2006
• Source: Sirion Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Panuveitis
• Uveitis

Intervention

Drug:
• Difluprednate Ophthalmic Emulsion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sirion Therapeutics, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The anterior chamber cell score was compared between baseline and Day 14.
Secondary	The anterior chamber cell score was compared between baseline and Days 3 and 7.
Secondary	The total symptom score (sum of eye pain, photophobia, blurred
Secondary	vision, foreign body sensation and lacrimation scores) and total
Secondary	sign score (sum of anterior chamber cell, anterior chamber flare,
Secondary	ciliary hyperemia, keratic precipitate and synechia of iris and
Secondary	posterior scores) were compared between baseline and Days 3, 7
Secondary	and 14.