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.
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