A Phase 3, multicenter, randomized, evaluator-blinded clinical trial to assess the safety and efficacy of Clobetasol propionate ophthalmic nanoemulsion, 0.05% compared to Prednisolone acetate, 1% in the treatment of inflammation after cataract surgery in pediatric population 0 to 3 years of age (CLOSE-3).

Inflammation and pain associated with ocular surgery

Number, frequency, severity and relationship to IMP of adverse events (AEs) up to last study visit, Number, frequency, severity and relationship to IMP of Serious AE (SAEs) up to last study visit, Proportion of patients discontinuing the study due to AEs, Proportion of patients discontinuing the study due to lack of efficacy, Change from baseline to each study visit in intraocular pressure (IOP), Change from baseline to each study visit in visual acuity and physical and eye examination parameters

Percentage of patients with anterior chamber inflammation of grade 0 at Visit 2 (Day 8±2), Visit 3 (Day 15±2), Visit 4 (Day 29±2) and Visit 5 (Day 43±3)., Change from baseline to Visit 2 (Day 8±2), Visit 3 (Day 15±2), Visit 4 (Day 29±2) and Visit 5 (Day 43±3) in the proportion of patients with different grades of anterior chamber inflammation, Proportion of patients with Grade 1, Grade 2, Grade 3 and Grade 4 of anterior chamber inflammation at Visit 1 (Day 1), Visit 2 (Day 8±2), Visit 3 (Day 15±2), Visit 4 (Day 29±2) and Visit 5 (Day 43±3)., Frequency of different signs and symptoms of ocular inflammation at baseline, Visit 2 (Day 8±2), Visit 3 (Day 15±2), Visit 4 (Day 29±2) and Visit 5 (Day 43±3)., Change from baseline to Visit 2 (Day 8±2), Visit 3 (Day 15±2), Visit 4 (Day 29±2) and Visit 5 (Day 43±3) in the Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale Score

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