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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Ocular gel

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 Type: Interventional
• Enrollment (Actual): 96
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Department of Clinical Pharmacology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Chloroprocaine; Chloroprocaine 3% ocular gel	Drug: Ocular gel; Instillation
PLACEBO_COMPARATOR: Placebo; Vehicle for chloroprocaine 3% ocular gel	Drug: Ocular gel; Instillation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants in Phase 2 With Anesthesia Success	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)	Day 1

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sintetica SA
• Investigators: Principal Investigator: Gerhard Garhoefer, Universitätsklinik für Klinische Pharmakologie

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 29, 2020
• Primary Completion (ACTUAL): November 6, 2020
• Study Completion (ACTUAL): December 9, 2020

Study Registration Dates

• First Submitted: January 19, 2021
• First Submitted That Met QC Criteria: February 10, 2021
• First Posted (ACTUAL): February 15, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 17, 2022
• Last Update Submitted That Met QC Criteria: March 8, 2022
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: CHL.3-02-2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No