A Phase II/III, Randomized, Double-Masked, Vehicle-Controlled, Efficacy, Safety and Tolerability Study of Chloroprocaine 3% Gel Eye Drops in Healthy Volunteers
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Sintetica SA
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- Number of Participants in Phase 2 With Anesthesia Success
Overview
Brief Summary
The study assess efficacy, safety and tolerability of Chloroprocaine 3% ophthalmic gel in healthy volunteers.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Signed and dated informed consent
- •Healthy male or female aged from 18 to 90 years
- •No clinically significant ocular or systemic disease
- •Ability to orally respond to pain
- •Ability to follow the visit schedule
Exclusion Criteria
- •Ophthalmic exclusion criteria
- •Eye movement disorder (i.e. Nystagmus)
- •Dacryocystitis and all other pathologies of tears drainage system
- •History of Inflammatory ocular disease (Iritis, uveitis, herpetic keratitis)
- •Corneal, epithelial, stromal or endothelial, residual or evolutionary disease (including corneal ulceration and superficial punctuate keratitis)
- •History of ocular traumatism, infection or inflammation within the last 3 months
- •Best corrected visual acuity \< 1/10
- •History of ophthalmic surgical complication (i.e. cystoid macular oedema)
- •Systemic/non ophthalmic exclusion criteria
- •General history:
Arms & Interventions
Chloroprocaine
Chloroprocaine 3% ocular gel
Intervention: Ocular gel (Drug)
Placebo
Vehicle for chloroprocaine 3% ocular gel
Intervention: Ocular gel (Drug)
Outcomes
Primary Outcomes
Number of Participants in Phase 2 With Anesthesia Success
Time Frame: Day 1
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)
Secondary Outcomes
- Mean Arterial Pressure(up to 8 days)
- Duration of Anesthesia Only in Patients in Phase 2(Day 1)
- Number of Participants With Adverse Events(Up to 29 days)
- Number of Participants With Anomalies in Corneal Fluorescein Staining(up to 8 days)
- Ocular Pressure(Follow up (up to 8 days))
- Number of Participants With Anomalies in Slip Lamp Examination(up to 8 days)