Study of Difluprednate Ophthalmic Emulsion in the Treatment of Postoperative Inflammation

Phase 2

Completed

• Conditions: Inflammation

• Registration Number: NCT00407225
• Lead Sponsor: Sirion Therapeutics, Inc.

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.

Study Timeline

• Study Start: 1999-12
• Study Completion: 2000-10
• Status Verified: 2006-11
• Study First Submitted: 2006-11-29
• Study First Submitted QC: 2006-11-29
• Study First Posted: 2006-12-04
• Last Update Submitted: 2006-12-05
• Last Update Posted: 2006-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.
The flare intensity on Day 72 (F7) was compared with the baseline flare intensity (F0).

Secondary Outcome Measures

Name	Time	Method
with the baseline total score (S0).
The total score of anterior chamber signs (cells and protein) on Day 72 (S7) was compared
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.