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Study of Difluprednate Ophthalmic Emulsion in the Treatment of Severe Uveitis

Primary Purpose

Uveitis, Panuveitis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Difluprednate Ophthalmic Emulsion
Sponsored by
Sirion Therapeutics, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uveitis

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    The anterior chamber cell score was compared between baseline and Day 14.

    Secondary Outcome Measures

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

    Full Information

    First Posted
    November 29, 2006
    Last Updated
    November 29, 2006
    Sponsor
    Sirion Therapeutics, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00407056
    Brief Title
    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

    2. Study Status

    Record Verification Date
    November 2006
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2002 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    June 2003 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Sirion Therapeutics, Inc.

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Uveitis, Panuveitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    20 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Difluprednate Ophthalmic Emulsion
    Primary Outcome Measure Information:
    Title
    The anterior chamber cell score was compared between baseline and Day 14.
    Secondary Outcome Measure Information:
    Title
    The anterior chamber cell score was compared between baseline and Days 3 and 7.
    Title
    The total symptom score (sum of eye pain, photophobia, blurred
    Title
    vision, foreign body sensation and lacrimation scores) and total
    Title
    sign score (sum of anterior chamber cell, anterior chamber flare,
    Title
    ciliary hyperemia, keratic precipitate and synechia of iris and
    Title
    posterior scores) were compared between baseline and Days 3, 7
    Title
    and 14.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Shigeaki Ono
    Organizational Affiliation
    Department of Ophthalmology and Visual Science, Graduate School of Medicine, Hokkaido University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Study of Difluprednate Ophthalmic Emulsion in the Treatment of Severe Uveitis

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