Study of Difluprednate Ophthalmic Emulsion in the Treatment of Postoperative Inflammation

Inflammation Clinical Trial

Official title:

Phase 2a Study of 0.05% Difluprednate Ophthalmic Emulsion in the Treatment of Postoperative Inflammation After Cataract Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00407225
• Other study ID #: SJE2079/2-01-PC
• Status: Completed
• Phase: Phase 2
• First received: November 29, 2006
• Last updated: December 5, 2006
• Start date: December 1999
• Est. completion date: October 2000

Study information

• Verified date: November 2006
• Source: Sirion Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inflammation

Intervention

Drug:
• Difluprednate Ophthalmic Emulsion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sirion Therapeutics, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The flare intensity on Day 7?2 (F7) was compared with the baseline flare intensity (F0).
Primary	The ratios of the flare intensity on Day 1 (F1), that on Day 3?1 (F3) and that on Day 7?2 (F7) to
Primary	the baseline flare intensity (F0) (F1/F0, F3/F0 and F7/F0, respectively) were determined. Each
Primary	ratio was compared between the 0.002% and 0.05% difluprednate groups to identify when the
Primary	between-group difference in the effect of difluprednate became significant.
Secondary	The total score of anterior chamber signs (cells and protein) on Day 7?2 (S7) was compared
Secondary	with the baseline total score (S0).
Secondary	As the secondary efficacy evaluation, the ratios of the total score of anterior chamber signs
Secondary	(cells and protein) on Day 1 (S1), that on Day 3?1 (S3) and that on Day 7?2 (S7) to the baseline
Secondary	total score (S0) (S1/S0, S3/S0 and S7/S0, respectively) were determined. Each ratio was
Secondary	compared between the 0.002% and 0.05% difluprednate groups to identify when the
Secondary	between-group difference in the effect of difluprednate became significant.