Study of Difluprednate Ophthalmic Emulsion in the Treatment of Postoperative Inflammation

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

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

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.

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)