Title

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
  • Phase

    Phase 2
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Intervention/Treatment

    difluprednate ...
  • Study Participants

    24
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.
Study Started
Dec 31
1999
Study Completion
Oct 31
2000
Last Update
Dec 06
2006
Estimate

Drug Difluprednate Ophthalmic Emulsion

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)
No Results Posted