Study of Difluprednate Ophthalmic Emulsion in the Treatment of Postoperative Inflammation

Sirion Therapeutics

Status and phase

Completed

Phase 2

Conditions

Inflammation

Treatments

Drug: Difluprednate Ophthalmic Emulsion

Study type

Interventional

Funder types

Industry

Identifiers

NCT00407225

SJE2079/2-01-PC

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

12 to 75 years old

Volunteers

No Healthy Volunteers

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)