Status:
COMPLETED
Study of Difluprednate Ophthalmic Emulsion in the Treatment of Postoperative Inflammation
Lead Sponsor:
Sirion Therapeutics, Inc.
Conditions:
Inflammation
Eligibility:
All Genders
20+ 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 efficacy endpoints in comparison with 0.1% BM ophthalmic solution, prior to investigation of the efficacy and safety of 0.05% DFBA ophthalmic emulsion in the treatment of po...
Eligibility Criteria
Inclusion
- Patients undergoing intraocular surgery (cataract surgery, cataract surgery + implantation of intraocular lens, vitreous surgery, cataract surgery + implantation of intraocular lens + vitreous surgery)
- 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
Exclusion
- Patients who did not meet all of the above inclusion criteria
- 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
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
End Date :
July 1 2003
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00406497
Start Date
April 1 2003
End Date
July 1 2003
Last Update
December 4 2006
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