RecruitingPhase 3NCT05724446

Clobetasol Propionate Ophthalmic Nanoemulsion, 0.05% in the Treatment of Inflammation After Cataract Surgery in Pediatric Population

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)

Sponsor

Salvat

Enrollment

60 participants

Start Date

Dec 12, 2022

Study Type

INTERVENTIONAL

Conditions

Cataracts Infantile

Summary

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.

Eligibility

Min Age: 0 MonthsMax Age: 3 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Clobetasol Propionate and a drug called Prednisolone acetate ophthalmic suspension, 1% for people with cataracts infantile. The study is currently recruiting participants at 1 location. People eligible for this study include aged 0 Months to 3 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGClobetasol Propionate

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).

DRUGPrednisolone acetate ophthalmic suspension, 1%

Microfine sterile ophthalmic suspension of dense and whitish appearance.

Locations(1)

Hospìtal Sant Joan de Deu

Barcelona, Spain

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NCT05724446