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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014