Study of Difluprednate Ophthalmic Emulsion in the Treatment of Postoperative Inflammation
This study has been completed.
Information provided by:
Sirion Therapeutics, Inc.
First received: November 29, 2006
Last updated: NA
Last verified: November 2006
History: No changes posted
The purpose of this phase 2 study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of postoperative inflammation.
Drug: Difluprednate Ophthalmic Emulsion
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
||Phase 2a Study of 0.05% Difluprednate Ophthalmic Emulsion in the Treatment of Postoperative Inflammation
Primary Outcome Measures:
- The variation from baseline in anterior chamber cell score on Day 14 (difference from baseline
- score) was compared between the test and control groups.
Secondary Outcome Measures:
- The variations from baseline in anterior chamber cell score on Days 3 and 7 were compared
- between the test and control groups.
- The numbers of patients with an anterior chamber cell score of 0 on Days 7 and 14 were
- compared between the test and control groups.
- The variations from baseline in anterior chamber flare score on Days 3, 7 and 14 were
- The variations from baseline in total sign and symptom scores on Days 3, 7 and 14 were
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
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 postoperative intraocular inflammation.
|Ages Eligible for Study:
||20 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00406497
Sirion Therapeutics, Inc.
||Professor, Department of Ophthalmology and Visual Science, Graduate School of Medicine, Hokkaido University
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 29, 2006
||November 29, 2006
||Japan: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 31, 2015
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs