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Study of Difluprednate Ophthalmic Emulsion in the Treatment of Postoperative Inflammation

Information source: Sirion Therapeutics, Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Inflammation

Intervention: Difluprednate Ophthalmic Emulsion (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Sirion Therapeutics, Inc.

Official(s) and/or principal investigator(s):
Kanjiro Masuda, Study Chair, Affiliation: Director, Kanto Rosai Hospital; Director, Japanese Red Cross Medical Center

Summary

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

Clinical Details

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

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

Primary outcome:

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:

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.

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

Minimum age: 12 Years. Maximum age: 75 Years. Gender(s): Both.

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)

Locations and Contacts

Additional Information

Starting date: December 1999
Last updated: December 5, 2006

Page last updated: August 20, 2015

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