Study of Difluprednate Ophthalmic Emulsion in the Treatment of Postoperative Inflammation
NCT ID: NCT00406497
Last Updated: 2006-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
24 participants
INTERVENTIONAL
2003-04-30
2003-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Difluprednate Ophthalmic Emulsion
Eligibility Criteria
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Inclusion Criteria
* Patients with anterior chamber cell score ≥2 on the next day of surgery
* Male and female patients aged ≥20 years (on the day of obtaining informed consent)
* Patients giving written informed consent prior to initiation of the study
* Patients receiving systemic administration of any corticosteroid or immunosuppressive drug, or topical application of corticosteroid ophthalmic ointment within 1 week before instillation of the investigational product
* Patients receiving topical injection of any corticosteroid in eyes before instillation of the investigational product (aqueous preparation: within 1 week before instillation of the investigational product, depot preparation: within 2 weeks before instillation of the investigational product)
* Patients receiving systemic administration of any non-steroidal anti-inflammatory drug or antiphlogistic enzyme
* Patients receiving instillation of any corticosteroid, non-steroidal anti-inflammatory ophthalmic solution or antiphologistic enzyme within 24 hours before ophthalmic examination prior to instillation of the investigational product (on the next day of surgery) (except instillation of non-steroidal anti-inflammatory ophthalmic solution at 3, 2, 1 and 0.5 hours before surgery)
* Patients with endogenous uveitis
* Patients planning to undergo surgery of the contralateral eye during the study period
* Patients with new intraocular bleeding after surgery
* Patients receiving gas or silicon oil in the vitreous body
* Patients with glaucoma or ocular hypertension (IOP on the next day of surgery ≥25 mmHg)
* Patients with superficial punctuate keratopathy or corneal ulcer
* Patients with any viral, bacterial or fungal keratoconjunctival disease
* Patients with allergy to any corticosteroid
* Patients requiring use of contact lens during the study period
* Women who were or might be pregnant, or lactating women
* Patients participating in another clinical study within 3 months before initiation of the present study
* Patients undergoing surgery under systemic anesthesia
20 Years
ALL
No
Sponsors
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Sirion Therapeutics, Inc.
INDUSTRY
Principal Investigators
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Shigeaki Ohno
Role: STUDY_CHAIR
Professor, Department of Ophthalmology and Visual Science, Graduate School of Medicine, Hokkaido University
Other Identifiers
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SJE2079/2-03-PC
Identifier Type: -
Identifier Source: org_study_id