• 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.
  

• 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.
  

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)