At a glance
ClinicalIndex Comparison Record- ✓Age from birth (≥1 day of life) through 17 years, not expected to turn 18 during study
- ✓Scheduled to undergo a routine clinical procedure requiring local ocular surface anesthesia (applanation tonometry, gonioscopy, UBM, ocular ultrasonography, retinal examination, etc.)
- ✓For females of childbearing potential (postmenarchal): negative pregnancy test, not lactating, and agreement to abstain from intercourse or use valid contraceptive until study completion
- ✓Signed written informed consent from both parents/legal representatives and written assent from adolescents aged 12-17 years (and whenever possible from children aged 6-11 years)
- ✕Previous ocular surgery less than 6 months before screening
- ✕Eye movement disorder (nystagmus)
- ✕History of herpetic keratitis
- ✕Corneal disease (epithelial, stromal, or endothelial; residual or evolutionary), including corneal ulceration, damage, or superficial punctate keratitis
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Observer-blind, Randomized Clinical Trial to Investigate and Compare the Clinical Efficacy of Chloroprocaine 3% Gel and Oxybuprocaine 0.4% Eye Drops Anesthesia for Clinical Practice in Pediatric Population
In Brief
A Phase 3 clinical trial evaluating Chloroprocaine 3% eye gel and Oxybuprocaine Hydrochloride 4 Mg/mL Eye Drops for Local Anesthetic. Completed, enrolled 74 participants across 3 sites.
Detailed 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
Study Details
Timeline
Interventions
ocular surface anesthesia
ocular surface anesthesia