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)
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.
• Male or female, aged 0 to 3 years old (have not had their 4th birthday) on the day of consent.
• Patients who are candidate for routine, uncomplicated cataract surgery in one eye with or without intraocular lens.
• Patients whose caregiver(s) is/are able and willing to comply with all treatment and follow-up procedures.
• Signed informed consent from (ICF) parents or patient's legally authorized representative(s).
• Patients who have undergone routine, uncomplicated cataract surgery in one eye with or without intraocular lens.
• Patients with clinical evidence of postoperative inflammation (anterior chamber inflammation grade \> 0).