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

Phase 2

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Ocular gel

• Registration Number: NCT04753710
• Lead Sponsor: Sintetica SA

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 Timeline

• Study Start: 2020-06-29
• Primary Completion: 2020-11-06
• Study Completion: 2020-12-09
• Status Verified: 2021-01
• Study First Submitted: 2021-01-19
• Study First Submitted QC: 2021-02-10
• Study First Posted: 2021-02-15
• Results First Submitted: 2021-10-12
• Results First Submitted QC: 2021-11-16
• Results First Posted: 2022-01-24
• Last Update Submitted: 2022-03-08
• Last Update Posted: 2022-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chloroprocaine	Ocular gel	Chloroprocaine 3% ocular gel
Placebo	Ocular gel	Vehicle for chloroprocaine 3% ocular gel

Primary Outcome Measures

Name	Time	Method
Number of Participants in Phase 2 With Anesthesia Success	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 Outcome Measures

Name	Time	Method
Mean Arterial Pressure	up to 8 days	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).
Duration of Anesthesia Only in Patients in Phase 2	Day 1	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)
Number of Participants With Adverse Events	Up to 29 days	Number of Participants with Ocular symptoms and Adverse events
Number of Participants With Anomalies in Corneal Fluorescein Staining	up to 8 days	Number of Participants with anomalies found with corneal fluorescein staining
Ocular Pressure	Follow up (up to 8 days)	Intraocular pressure (mmHg)
Number of Participants With Anomalies in Slip Lamp Examination	up to 8 days	Number of Participants with Anomalies in Slip Lamp Examination

Trial Locations

Locations (1)

Department of Clinical Pharmacology; 🇦🇹 Vienna, Austria