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

NCT04753710 | Completed Phase 2 Results

• 1 other identifier: CHL.3-02-2019
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Duration of Anesthesia Only in Patients in Phase 2

  Day 1

• Number of Participants With Adverse Events

  Up to 29 days

• Mean Arterial Pressure

  up to 8 days

• Number of Participants With Anomalies in Slip Lamp Examination

  up to 8 days

• Number of Participants With Anomalies in Corneal Fluorescein Staining

  up to 8 days

Study Arms (2)

Chloroprocaine

EXPERIMENTAL

Chloroprocaine 3% ocular gel

Drug: Ocular gel

Placebo

PLACEBO COMPARATOR

Vehicle for chloroprocaine 3% ocular gel

Drug: Ocular gel

Interventions

Ocular gel DRUG

Instillation

Chloroprocaine; Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• General history:
• 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
• 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
• Inability of subject to understand the study procedures and thus inability to give informed consent

Sponsors & Collaborators

• Sintetica SA: lead

Study Sites (1)

Department of Clinical Pharmacology

Vienna, 1090, Austria

Location

Results Point of Contact

• Title: Roberta Bianchi
• Organization: Sintetica SA

rbianchi@sintetica.com

0041 91 640 42 50

Study Officials

• Gerhard Garhoefer

  Universitätsklinik für Klinische Pharmakologie

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: February 15, 2021
• Study Start: June 29, 2020
• Primary Completion: November 6, 2020
• Study Completion: December 9, 2020
• Last Updated: March 17, 2022
• Results First Posted: January 24, 2022

Record last verified: 2021-01

Locations

AU (1)