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

Recruiting Phase 3 Interventional Study
Cataracts Infantile
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
0 Months – 3
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Salvat · Industry
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About This Trial
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 per…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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 …
Contacts

Enrique Jimenez

+34 933946400

ejimenez@svt.com

CONTACT