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

A Phase II/III, Randomized, Double-Masked, Vehicle-Controlled, Efficacy, Safety and Tolerability Study of Chloroprocaine 3% Gel Eye Drops in Healthy Volunteers

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.

Inclusion Criteria:

1. Signed and dated informed consent
2. Healthy male or female aged from 18 to 90 years
3. No clinically significant ocular or systemic disease
4. Ability to orally respond to pain
5. Ability to follow the visit schedule

Exclusion Criteria:

Ophthalmic exclusion criteria

1. Eye movement disorder (i.e. Nystagmus)

2. Dacryocystitis and all other pathologies of tears drainage system

3. History of Inflammatory ocular disease (Iritis, uveitis, herpetic keratitis)

4. Corneal, epithelial, stromal or endothelial, residual or evolutionary disease (including corneal ulceration and superficial punctuate keratitis)

5. History of ocular traumatism, infection or inflammation within the last 3 months

6. Best corrected visual acuity < 1/10

7. History of ophthalmic surgical complication (i.e. cystoid macular oedema)

   Systemic/non ophthalmic exclusion criteria

8. General history:

   8.1 Deafness 8.2 Excessive anxiety

9. 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

10. Allergic history: Known hypersensitivity to one of the components of the study medications or to test products

    Specific non-inclusion criteria for women:

11. Pregnancy, lactation

12. Women without an effective method of contraception (i.e. oral contraceptive, intra-uterine device, subcutaneous contraceptive implant) OR

13. Women not hysterectomised, not menopausal nor surgically sterilized

    Exclusion criteria related to general conditions:

14. Inability of subject to understand the study procedures and thus inability to give informed consent

15. Non-compliant subject (e.g. not willing to attend the follow-up visits, way of life interfering with compliance)

16. Participation in another clinical study

17. Already included once in this study

18. Ward of court

19. Subject not covered by the Social Security

    Exclusion criteria related to previous and concomitant medications (taken within 15 days prior screening visit)

20. Use of systemic opioids and opioid drugs

21. Topical ocular treatment with anaesthetic action

22. Use of systemic analgesic drugs (except paracetamol, which will be allowed after Visit 2)