The study assess efficacy, safety and tolerability of Chloroprocaine 3% ophthalmic gel in healthy volunteers.
The study is carried out in 2 parts. In part I, safety and tolerability is assessed in three groups (12 subjects per group) for single and multiple instillations (1 drop, 3 drops and 3+3 drops). In each group, 9 subjects is randomized to receive Chloroprocaine 3% Gel and 3 subjects receive vehicle as control in the right eye. After part I is completed, an internal independent board review safety endpoints of data collected from these first subjects and advise to go on with further enrollment. If no safety concerns arise, in part II efficacy, safety and tolerability is assessed in 60 healthy subjects for the 3 drops dose regimen. 40 subjects receive Chloroprocaine 3% Gel and 20 receive vehicle (2:1 randomization) in the right eye.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
96
Instillation
Department of Clinical Pharmacology
Vienna, Austria
Number of Participants in Phase 2 With Anesthesia Success
Estimate the proportion of subjects experiencing full anaesthesia of the ocular surface 5 minutes after administration of Chloroprocaine 3% ophthalmic gel (the intent was to collect and only report data for Participants who were in Phase 2)
Time frame: Day 1
Duration of Anesthesia Only in Patients in Phase 2
Duration of anesthesia (min) for subjects in phase 2 (the intent was to collect and only report data for Participants who were in Phase 2)
Time frame: Day 1
Number of Participants With Adverse Events
Number of Participants with Ocular symptoms and Adverse events
Time frame: Up to 29 days
Mean Arterial Pressure
Mean arterial pressure (mmHg) is defined as the average pressure in a patient's arteries during one cardiac cycle. It is considered a better indicator of perfusion to vital organs than systolic blood pressure (SBP).
Time frame: up to 8 days
Number of Participants With Anomalies in Slip Lamp Examination
Number of Participants with Anomalies in Slip Lamp Examination
Time frame: up to 8 days
Number of Participants With Anomalies in Corneal Fluorescein Staining
Number of Participants with anomalies found with corneal fluorescein staining
Time frame: up to 8 days
Ocular Pressure
Intraocular pressure (mmHg)
Time frame: Follow up (up to 8 days)
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