Inflammation
Conditions
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 postoperative intraocular inflammation.
Interventions
Sponsors
Sirion Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 cell score on Days 3 and 7 were compared | — |
| The variations from baseline in total sign and symptom scores on Days 3, 7 and 14 were | — |
| The variations from baseline in anterior chamber flare score on Days 3, 7 and 14 were | — |
| between the test and control groups. | — |
Outcome results
None listed