Study of Difluprednate Ophthalmic Emulsion in the Treatment of Postoperative Inflammation

Sirion Therapeutics

Status and phase

Completed

Phase 2

Conditions

Inflammation

Treatments

Drug: Difluprednate Ophthalmic Emulsion

Study type

Interventional

Funder types

Industry

Identifiers

NCT00406497

SJE2079/2-03-PC

Details and patient eligibility

About

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

Full 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 postoperative intraocular inflammation.

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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