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