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 the efficacy and safety of 0.002% and 0.05% difluprednate ophthalmic emulsions in patients with postoperative inflammation after cataract surgery (implantation of intraocular lens). In addition, the evaluation system for a future dose-finding phase III study of difluprednate ophthalmic emulsion will be established.
Interventions
Sponsors
Sirion Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
12 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients with a mean postoperative (on the day of surgery or the day after surgery) flare intensity of 30 photon counts/msec * Male and female patients aged 12 and \<75 years who were able to accurately express their own symptoms * Patients providing written informed consent prior to the start of the study * Inpatients (patients were allowed to be discharged from the hospital during the study period)
Exclusion criteria
* Patients who did not meet any of the above inclusion criteria * Patients receiving systemic administration, or topical application to the head or face (including instillation to the eyes) of any steroid, nonsteroidal anti-inflammatory drug, antiphlogistic enzyme, immunosuppressive drug or colchicine within 1 week prior to the start of the study treatment * Patients with glaucoma or ocular hypertension (IOP: 21 mmHg) * Patients with corneal abrasion or ulcer * Patients with any viral keratoconjunctival disease, tuberculosus eye disease, fungal eye disease or bacterial eye disease * Patients with diabetes who met any of the following criteria * HbA1C was 9.0% within 1 month prior to obtaining informed consent. * Proliferative diabetic retinopathy was present. * Rubeosis iridis was present. * Patients with allergy to steroids * Patients requiring the use of contact lens during the study period * Women who were or might be pregnant * Patients participating in another clinical study within 6 months prior to the start of the present study * Patients sensitive to steroids (patients who previously experienced increased IOP after instillation of a steroid) * Patients with a Grade 5 nuclear hardness as diagnosed according to Emery-Little classification * Patients with fibrins or posterior rupture at baseline (F0)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The flare intensity on Day 72 (F7) was compared with the baseline flare intensity (F0). | — |
| The ratios of the flare intensity on Day 1 (F1), that on Day 31 (F3) and that on Day 72 (F7) to | — |
| the baseline flare intensity (F0) (F1/F0, F3/F0 and F7/F0, respectively) were determined. Each | — |
| ratio was compared between the 0.002% and 0.05% difluprednate groups to identify when the | — |
| between-group difference in the effect of difluprednate became significant. | — |
Secondary
| Measure | Time frame |
|---|---|
| compared between the 0.002% and 0.05% difluprednate groups to identify when the | — |
| The total score of anterior chamber signs (cells and protein) on Day 72 (S7) was compared | — |
| between-group difference in the effect of difluprednate became significant. | — |
| with the baseline total score (S0). | — |
| As the secondary efficacy evaluation, the ratios of the total score of anterior chamber signs | — |
| (cells and protein) on Day 1 (S1), that on Day 31 (S3) and that on Day 72 (S7) to the baseline | — |
| total score (S0) (S1/S0, S3/S0 and S7/S0, respectively) were determined. Each ratio was | — |
Outcome results
None listed