Efficacy, Safety and Tolerability Study of Chloroprocaine 3% Gel Eye Drops in Healthy Volunteers

Sintetica

Status and phase

Completed

Phase 3

Phase 2

Conditions

Healthy Volunteers

Treatments

Drug: Ocular gel

Study type

Interventional

Funder types

Industry

Identifiers

NCT04753710

CHL.3-02-2019

Details and patient eligibility

About

The study assess efficacy, safety and tolerability of Chloroprocaine 3% ophthalmic gel in healthy volunteers.

Full 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.

Enrollment

96 patients

Sex

All

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

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:

8.1 Deafness 8.2 Excessive anxiety
Any other medical or surgical history, disorder or disease such as acute or chronic severe organic disease: hepatic, endocrine neoplastic, haematological diseases, severe psychiatric illness, relevant cardiovascular abnormalities (such as unstable angina, uncontrolled hypertension: systolic blood pressure over 200 mm Hg, diastolic blood pressure over 100 mm Hg) and/or any complicating factor or structural abnormality judged by the investigator to be incompatible with the study
Allergic history: Known hypersensitivity to one of the components of the study medications or to test products

Specific non-inclusion criteria for women:
Pregnancy, lactation
Women without an effective method of contraception (i.e. oral contraceptive, intra-uterine device, subcutaneous contraceptive implant) OR
Women not hysterectomised, not menopausal nor surgically sterilized

Exclusion criteria related to general conditions:
Inability of subject to understand the study procedures and thus inability to give informed consent
Non-compliant subject (e.g. not willing to attend the follow-up visits, way of life interfering with compliance)
Participation in another clinical study
Already included once in this study
Ward of court
Subject not covered by the Social Security

Exclusion criteria related to previous and concomitant medications (taken within 15 days prior screening visit)
Use of systemic opioids and opioid drugs
Topical ocular treatment with anaesthetic action
Use of systemic analgesic drugs (except paracetamol, which will be allowed after Visit 2)