Text Size

Study of Difluprednate Ophthalmic Emulsion in the Treatment of Postoperative Inflammation

This study has been completed.
Sponsor:
Information provided by:
Sirion Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00407225
First received: November 29, 2006
Last updated: December 5, 2006
Last verified: November 2006
History of Changes
  Purpose

The purpose of this phase 2 study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of postoperative inflammation.


Condition Intervention Phase
Inflammation
 Drug: Difluprednate Ophthalmic Emulsion
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Phase 2a Study of 0.05% Difluprednate Ophthalmic Emulsion in the Treatment of Postoperative Inflammation After Cataract Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sirion Therapeutics, Inc.:

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.

Estimated Enrollment: 24
Study Start Date: December 1999
Estimated Study Completion Date: October 2000
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.

  Eligibility

Ages Eligible for Study:   12 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00407225

Sponsors and Collaborators
Sirion Therapeutics, Inc.
Investigators
Study Chair: Kanjiro Masuda Director, Kanto Rosai Hospital; Director, Japanese Red Cross Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00407225     History of Changes
Other Study ID Numbers: SJE2079/2-01-PC
Study First Received: November 29, 2006
Last Updated: December 5, 2006
Health Authority: Japan: Institutional Review Board

Additional relevant MeSH terms:
Inflammation
Pathologic Processes
Difluprednate
Fluprednisolone
Glucocorticoids
Hormones
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013