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Study of Difluprednate Ophthalmic Emulsion in the Treatment of Postoperative Inflammation

Primary Purpose

Inflammation

Status
Completed
Phase
Phase 2
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 Inflammation

Eligibility Criteria

12 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with a mean postoperative (on the day of surgery or the day after surgery) flare intensity of 30 photon counts/msec
  • Male and female patients aged 12 and <75 years who were able to accurately express their own symptoms
  • Patients providing written informed consent prior to the start of the study
  • Inpatients (patients were allowed to be discharged from the hospital during the study period)

Exclusion Criteria:

  • Patients who did not meet any of the above inclusion criteria
  • Patients receiving systemic administration, or topical application to the head or face (including instillation to the eyes) of any steroid, nonsteroidal anti-inflammatory drug, antiphlogistic enzyme, immunosuppressive drug or colchicine within 1 week prior to the start of the study treatment
  • Patients with glaucoma or ocular hypertension (IOP: 21 mmHg)
  • Patients with corneal abrasion or ulcer
  • Patients with any viral keratoconjunctival disease, tuberculosus eye disease, fungal eye disease or bacterial eye disease

  • Patients with diabetes who met any of the following criteria

    • HbA1C was 9.0% within 1 month prior to obtaining informed consent.
    • Proliferative diabetic retinopathy was present.
    • Rubeosis iridis was present.
  • Patients with allergy to steroids
  • Patients requiring the use of contact lens during the study period
  • Women who were or might be pregnant
  • Patients participating in another clinical study within 6 months prior to the start of the present study
  • Patients sensitive to steroids (patients who previously experienced increased IOP after instillation of a steroid)
  • Patients with a Grade 5 nuclear hardness as diagnosed according to Emery-Little classification
  • Patients with fibrins or posterior rupture at baseline (F0)

Sites / Locations

    Outcomes

    Primary Outcome Measures

    The flare intensity on Day 72 (F7) was compared with the baseline flare intensity (F0).
    The ratios of the flare intensity on Day 1 (F1), that on Day 31 (F3) and that on Day 72 (F7) to
    the baseline flare intensity (F0) (F1/F0, F3/F0 and F7/F0, respectively) were determined. Each
    ratio was compared between the 0.002% and 0.05% difluprednate groups to identify when the
    between-group difference in the effect of difluprednate became significant.

    Secondary Outcome Measures

    The total score of anterior chamber signs (cells and protein) on Day 72 (S7) was compared
    with the baseline total score (S0).
    As the secondary efficacy evaluation, the ratios of the total score of anterior chamber signs
    (cells and protein) on Day 1 (S1), that on Day 31 (S3) and that on Day 72 (S7) to the baseline
    total score (S0) (S1/S0, S3/S0 and S7/S0, respectively) were determined. Each ratio was
    compared between the 0.002% and 0.05% difluprednate groups to identify when the
    between-group difference in the effect of difluprednate became significant.

    Full Information

    First Posted
    November 29, 2006
    Last Updated
    December 5, 2006
    Sponsor
    Sirion Therapeutics, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00407225
    Brief Title
    Study of Difluprednate Ophthalmic Emulsion in the Treatment of Postoperative Inflammation
    Official Title
    Phase 2a Study of 0.05% Difluprednate Ophthalmic Emulsion in the Treatment of Postoperative Inflammation After Cataract Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2006
    Overall Recruitment Status
    Completed
    Study Start Date
    December 1999 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    October 2000 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Sirion Therapeutics, Inc.

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this phase 2 study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of postoperative inflammation.
    Detailed Description
    The objective is to assess the efficacy and safety of 0.002% and 0.05% difluprednate ophthalmic emulsions in patients with postoperative inflammation after cataract surgery (implantation of intraocular lens). In addition, the evaluation system for a future dose-finding phase III study of difluprednate ophthalmic emulsion will be established.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    24 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Difluprednate Ophthalmic Emulsion
    Primary Outcome Measure Information:
    Title
    The flare intensity on Day 72 (F7) was compared with the baseline flare intensity (F0).
    Title
    The ratios of the flare intensity on Day 1 (F1), that on Day 31 (F3) and that on Day 72 (F7) to
    Title
    the baseline flare intensity (F0) (F1/F0, F3/F0 and F7/F0, respectively) were determined. Each
    Title
    ratio was compared between the 0.002% and 0.05% difluprednate groups to identify when the
    Title
    between-group difference in the effect of difluprednate became significant.
    Secondary Outcome Measure Information:
    Title
    The total score of anterior chamber signs (cells and protein) on Day 72 (S7) was compared
    Title
    with the baseline total score (S0).
    Title
    As the secondary efficacy evaluation, the ratios of the total score of anterior chamber signs
    Title
    (cells and protein) on Day 1 (S1), that on Day 31 (S3) and that on Day 72 (S7) to the baseline
    Title
    total score (S0) (S1/S0, S3/S0 and S7/S0, respectively) were determined. Each ratio was
    Title
    compared between the 0.002% and 0.05% difluprednate groups to identify when the
    Title
    between-group difference in the effect of difluprednate became significant.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with a mean postoperative (on the day of surgery or the day after surgery) flare intensity of 30 photon counts/msec Male and female patients aged 12 and <75 years who were able to accurately express their own symptoms Patients providing written informed consent prior to the start of the study Inpatients (patients were allowed to be discharged from the hospital during the study period) Exclusion Criteria: Patients who did not meet any of the above inclusion criteria Patients receiving systemic administration, or topical application to the head or face (including instillation to the eyes) of any steroid, nonsteroidal anti-inflammatory drug, antiphlogistic enzyme, immunosuppressive drug or colchicine within 1 week prior to the start of the study treatment Patients with glaucoma or ocular hypertension (IOP: 21 mmHg) Patients with corneal abrasion or ulcer Patients with any viral keratoconjunctival disease, tuberculosus eye disease, fungal eye disease or bacterial eye disease Patients with diabetes who met any of the following criteria HbA1C was 9.0% within 1 month prior to obtaining informed consent. Proliferative diabetic retinopathy was present. Rubeosis iridis was present. Patients with allergy to steroids Patients requiring the use of contact lens during the study period Women who were or might be pregnant Patients participating in another clinical study within 6 months prior to the start of the present study Patients sensitive to steroids (patients who previously experienced increased IOP after instillation of a steroid) Patients with a Grade 5 nuclear hardness as diagnosed according to Emery-Little classification Patients with fibrins or posterior rupture at baseline (F0)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kanjiro Masuda
    Organizational Affiliation
    Director, Kanto Rosai Hospital; Director, Japanese Red Cross Medical Center
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Study of Difluprednate Ophthalmic Emulsion in the Treatment of Postoperative Inflammation

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