Multicenter, randomized, evaluator-blinded clinical trial compared to Prednisolone acetate, 1% in the treatment of inflammation and pain after cataract surgery in pediatric population. This study will assess the safety of Clobetasol propionate ophthalmic nanoemulsion, 0.05% to that of Prednisolone acetate, 1% when administering one drop four times a day (QID) for 14 days followed by a tapering period of 14 days after cataract surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Clobetasol propionate ophthalmic nanoemulsion 0.05 % is an oil-in-water (O/W), clear or slightly yellowish nanoemulsion containing the active ingredient clobetasol propionate at a concentration of 0.05% weight per weight (w/w).
Microfine sterile ophthalmic suspension of dense and whitish appearance.
Hospìtal Sant Joan de Deu
Barcelona, Spain
RECRUITINGAssess the safety of Clobetasol propionate ophthalmic nanoemulsion, 0.05% treatment after cataract surgery in pediatric population 0 to 3 years of age, compared to Prednisolone acetate ophthalmic suspension, 1%.
Number, frequency, severity, and relationship to IMP of adverse events (AEs) up to last study visit.
Time frame: Day 43
Assess the efficacy on ocular inflammation of Clobetasol propionate ophthalmic nanoemulsion, 0.05% treatment after cataract surgery in pediatric population 0 to 3 years of age, compared to Prednisolone acetate ophthalmic suspension, 1%.
Percentage of patients with anterior chamber inflammation of grade 0. Anterior chamber inflammation is graded on a 5-point scale: 0 = None: Clear anterior chamber with no visible clouding (Tyndall effect and cells combined). Red reflex normal. 1. = Mild: Mild anterior chamber clouding. Clear iris pattern on visualization. Red reflex normal. 2. = Moderate: Moderate anterior chamber clouding. 3. = Severe: Severe anterior chamber clouding. Iris pattern not clearly visualized. Red reflex diminished. 4. = Very severe: Severe anterior chamber clouding with a white and/or milky appearance of the anterior chamber. Red reflex absent or severely diminished.
Time frame: Day 15
Assess the efficacy on pain of Clobetasol propionate ophthalmic nanoemulsion, 0.05% treatment after cataract surgery in pediatric population 0 to 3 years of age, compared to Prednisolone acetate ophthalmic suspension, 1%.
Change in the Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale Score. Higher scores mean a worse outcome. Each of the five categories (F) Face; (L) Legs; (A) Activity; (C) Cry; (C) Consolability is scored from 0-2, which results in a total score between zero and ten.
Time frame: Day 15
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