NCT05724446

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Salvat · Industry
• Sex: All
• Age: 0 Months – 3 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cataracts Infantile

Interventions

Type	Name	Description
DRUG	Clobetasol 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).
DRUG	Prednisolone acetate ophthalmic suspension, 1%	Microfine sterile ophthalmic suspension of dense and whitish appearance.

Timeline

• Start date: 2022-12-12
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2023-02-13
• Last updated: 2024-09-27

Locations

1 site across 1 country: Spain

Regulatory

• FDA-regulated drug study