drugset / Trial / NCT05926258
Efficacy and Safety of Chloroprocaine 3% Gel and Oxybuprocaine 0.4% Eye Drops Anesthesia in Pediatric Population
RandomizedParallel-groupSingle-blindTreatment
Summary
The goal of this clinical trial is to assess the efficacy and safety of Chloroprocaine 3% eye gel compared to Oxybuprocaine 0,4% eye drops when used for inducing ocular surface anesthesia in pediatric patients. 74 Participants (male and female, aged 0-17 yrs) will be 1:1 randomized for receiving either the test drug (Chloroprocaine) or the reference drug (Oxybuprocaine) before undergoing to ocular exam who needs ocular surface anesthesia. The successful surface anesthesia will be evaluated 5 minutes after receiving 2 drops (1 minute apart) of either test or reference drug by an eye spear sponge
Timeline
- Start
- 2024-05-23
- Primary completion
- 2025-03-13
- Completion
- 2025-03-13
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Benoxinate | Small molecule | 4 mg/ml | Topical |
| Subject | Chloroprocaine | Other / unclassified | 3 % | Topical |
Indications
No indication recorded.