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 2Lead Sponsor
Sirion TherapeuticsStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
InflammationIntervention/Treatment
difluprednate ...Study Participants
24The 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)