Study of Difluprednate Ophthalmic Emulsion in the Treatment of Postoperative Inflammation

Study Overview
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Brief Summary
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The purpose of this phase 2 study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of postoperative inflammation.

Detailed Description
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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.

Official Title
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Phase 2a Study of 0.05% Difluprednate Ophthalmic Emulsion in the Treatment of Postoperative Inflammation

Conditions
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Inflammation

Intervention / Treatment
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* Drug: Difluprednate Ophthalmic Emulsion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Difluprednate Ophthalmic Emulsion|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  |