Study of Difluprednate Ophthalmic Emulsion in the Treatment of Postoperative Inflammation

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

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

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.

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