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

NCT04779606 | Completed Phase 1 Results

• 1 other identifier: CHL.3-01-2020
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

The study evaluate the efficacy, safety and local tolerability of Chloroprocaine 3% ophthalmic gel as compared to matching placebo in healthy subjects.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• Number of Participants Gaining Full Conjunctival Anesthesia of the Ocular Surface

  Number of partecipants gaining full conjunctival anesthesia of the ocular surface, evaluated by conjunctiva pinching (0.3-mm forceps), 5 minutes after administration of Chloroprocaine 3% ophthalmic gel, in comparison to placebo - only study eye (right eye)

  Day 1

Secondary Outcomes (10)

• Time to Anesthesia, Evaluated by Conjunctiva Pinching (0.3-mm Forceps) - Only Study Eye (Right Eye)

  Day 1

• Duration of Anesthesia - Only Right Eye

  Day 1

• Visual Acuity (EDTRS Chart) - Both Eyes

  Up to day 7

• Ocular Symptoms

  Up to day 7

• Ocular Signs by Slit Lamp Examination

  Up to day 7

Study Arms (2)

Chloroprocaine

EXPERIMENTAL

Chloroprocaine 3% ocular gel (30 mg/mL), 3 drops instilled at a 1 min ± 15 sec interval.

Drug: Ocular gel

Placebo

PLACEBO COMPARATOR

Vehicle for chloroprocaine 3% ocular gel, 3 drops instilled at a 1 min ± 15 sec interval.

Drug: Ocular gel

Interventions

Ocular gel DRUG

3 drops instilled in the right eye

Also known as: No other intervention names

Chloroprocaine; Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Sex and age: Healthy men and women, 18 - 55 years inclusive
• Body Mass Index: 18.5-30 kg/m2 inclusive
• Vital signs: Systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, heart rate 50-90 bpm, measured after 5 min at rest in the sitting position
• Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the Investigator and to comply with the requirements of the entire study
• Contraception and fertility: women of child-bearing potential must be using at least one of the following reliable methods of contraception:
• Hormonal oral, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit;
• A non-hormonal intrauterine device or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months before the screening visit
• A male sexual partner who agrees to use a male condom with spermicide
• A sterile sexual partner Female participants of non-child-bearing potential or in post-menopausal status for at least 1 year will be admitted. For all women, urine pregnancy test result must be negative at screening.

You may not qualify if:

• Physical findings: Clinically significant abnormal physical findings which could interfere with the objectives of the study
• Visual acuity: Best corrected visual acuity \< 1/10
• Concomitant medications: Medications, including over the counter medications and herbal remedies, systemic opioids and morphine drugs, topical ocular products with anaesthetic action, systemic analgesic drugs, for 2 weeks before study screening
• Ophthalmic diseases: Clinically significant ocular disease; eye movement disorder (i.e. nystagmus); dacryocystitis and all others pathologies of tears drainage system; corneal, epithelial, stromal or endothelial, residual or evolutionary disease (including corneal ulceration and superficial punctuate keratitis); history of inflammatory ocular disease (iritis, uveitis, herpetic keratitis), history of ocular traumatism, infection or inflammation within the last 3 months or history of any other ocular disease that may affect the outcome of the study or the subject's safety
• Ophthalmic surgery: History of ophthalmic surgical complications (e.g. cystoid macular oedema) in the last 6 months
• Diseases: Significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine, psychiatric or neurological diseases or surgeries that may interfere with the aim of the study
• Allergy: Ascertained or presumptive hypersensitivity to the active principle and/or ingredients of investigational products; history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study
• Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study. The 3-month interval is calculated as the time between the first calendar day of the month that follows the last visit of the previous study and the first day of the present study
• Drug, alcohol, caffeine, tobacco: history of drug, alcohol \[greater than 1 drink/day for women and greater than 2 drinks/day for men, defined according to the USDA Dietary Guidelines 2015-2020\], caffeine (greater than 5 cups coffee/tea/day) or tobacco abuse (greater than or equal 10 cigarettes/day)
• Alcohol test: positive alcohol breath test at Day 1
• Pregnancy (women only): positive or missing pregnancy test at screening, pregnant or lactating women

Sponsors & Collaborators

• Sintetica SA: lead

Study Sites (1)

CROSS Research S.A.

Arzo, Switzerland

Location

Results Point of Contact

• Title: Dr.Elisabetta Donati, Corporate Director Scientific Affairs
• Organization: Sintetica SA

edonati@sintetica.com

+41.91.640.42.50

Study Officials

• Milko Radicioni

  CROSS Research S.A., Phase I Clinical Unit, Arzo, Switzerland

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• 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: March 3, 2021
• Study Start: June 16, 2020
• Primary Completion: October 13, 2020
• Study Completion: October 20, 2020
• Last Updated: September 16, 2021
• Results First Posted: September 16, 2021

Record last verified: 2021-06

Locations

CH (1)