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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00407056
Other study ID # SJE2079/3-02-PC
Secondary ID
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
Est. primary completion date
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


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.
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