Status:
COMPLETED
Study of Difluprednate Ophthalmic Emulsion in the Treatment of Postoperative Inflammation
Lead Sponsor:
Sirion Therapeutics, Inc.
Conditions:
Inflammation
Eligibility:
All Genders
12-75 years
Phase:
PHASE2
Brief Summary
The purpose of this phase 2 study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of postoperative inflammation.
Detailed 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 intraocula...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 1 1999
Trial Type :
INTERVENTIONAL
End Date :
October 1 2000
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00407225
Start Date
December 1 1999
End Date
October 1 2000
Last Update
December 6 2006
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