Healthy SubjectsPhase 1/2NCT04779606
Efficacy, Safety and Local Tolerability Study of Chloroprocaine 3% Gel Eye Drops in Healthy Volunteers
A Phase 1/2 study testing Ocular gel in people with Healthy Subjects, run by Sintetica SA at 1 site in Switzerland.
Trial summary
The study evaluate the efficacy, safety and local tolerability of Chloroprocaine 3% ophthalmic gel as compared to matching placebo in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Ocular gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteSwitzerland
- Study dates
- 16 Jun 2020to 20 Oct 2020
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Informed consent: Signed written informed consent before inclusion in the study
- 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:
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/II, Randomized, Placebo-controlled, Double-masked, Efficacy, Safety and Local Tolerability Study of Chloroprocaine 3% Gel Eye Drops in Healthy Volunteers
The study evaluate the efficacy, safety and local tolerability of Chloroprocaine 3% ophthalmic gel as compared to matching placebo in healthy subjects.
Read the detailed description
One hundred and five (105) healthy male and female subjects will be randomised in a 4:1 ratio to receive a single ocular instillation of Chloroprocaine 3% ophthalmic gel or matching placebo (vehicle) (84 subjects will receive chloroprocaine and 21 subjects will receive placebo). The assigned investigational product (3 drops) will be instilled in the right eye of each subject. Administrations will be performed at the clinical centre by the Investigator or his deputy on study day 1. For each administration, the 3 drops will be instilled at a 1 min ± 15 sec interval.
- Conditions
- Healthy Subjects
- Being tested
- Ocular gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ocular gelDrug
Also called No other intervention names
3 drops instilled in the right eye
| Study group | Role | What they receive |
|---|---|---|
| Chloroprocaine | Experimental | Chloroprocaine 3% ocular gel (30 mg/mL), 3 drops instilled at a 1 min ± 15 sec interval. Receives: Drug: Ocular gel |
| Placebo | Placebo comparator | Vehicle for chloroprocaine 3% ocular gel, 3 drops instilled at a 1 min ± 15 sec interval. Receives: Drug: Ocular gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Day 1
Secondary outcomes (10)
Time to Anesthesia, Evaluated by Conjunctiva Pinching (0.3-mm Forceps) - Only Study Eye (Right Eye)
Time to anesthesia, evaluated by conjunctiva pinching (0.3-mm forceps) - only study eye (right eye)
Measured: Day 1
Duration of Anesthesia - Only Right Eye
Duration of anesthesia, evaluated by conjunctiva pinching (0.3-mm forceps) - only study eye (right eye)
Measured: Day 1
Visual Acuity (EDTRS Chart) - Both Eyes
Visual acuity will be assessed, for all subjects and both eyes using an EDTRS chart (visual acuity is scored with reference to the logarithm of the minimum angle of resolution, an observer who can resolve details as small as 1 minute of visual angle scores LogMAR 0, since the base-10 logarithm of 1 is 0; an observer who can resolve details as small as 2 minutes of visual angle (i.e., reduced acuity) scores LogMAR 0.3, since the base-10 logarithm of 2 is near-approximately 0.3; and so on)
Measured: Up to day 7
Ocular Symptoms
The ocular symptoms will be assessed: burning, stinging, itching, foreign body sensation.
Scores will be determined using a 100 mm VAS where 0 means "no symptoms" and 100 means "worst possible discomfort".
Measured: Up to day 7
Ocular Signs by Slit Lamp Examination
Slit lamp biomicroscopy will be performed for the assessment of the following parameters:
conjunctival redness, anterior chamber flare, conjunctival chemosis, eyelid swelling.
Presence and severity will be graded according to a 4 point scale, where (0) none, (1) mild, (2) moderate, (3) severe.
Measured: Up to day 7
Corneal Fluorescein Staining by Slit Lamp Examination - Both Eyes
Fluorescein will be used to detect corneal epithelial defects using slit lamp biomicroscopy. As grading scale for corneal damage, the NEI/Industry Workshop guidelines will be used. The cornea will be divided into five sectors (central, superior, inferior, nasal and temporal), each of which is scored on a scale of 0-3, where 0 means no staining and 3 means maximum staining, with a maximal score of 15.
Measured: Up to day 7
Intraocular Pressure (IOP) - Both Eyes
Intraocular pressure will be measured with a slit-lamp mounted Goldmann applanation tonometer. Before each measurement one drop of oxybuprocaine hydrochloride combined with sodium fluorescein will be used for local anaesthesia of the cornea.
Measured: Up to day 7
Fundus Ophthalmoscopy (Vitreous, Macula, Retina and Optic Nerve Head) With the Slit Lamp - Both Eyes
Indirect fundus ophthalmoscopy will be performed, for all subjects and both eyes, with the observation at the slit lamp using a +90 diopters Volk lens.The evaluation is performed with a grading scale: 0 None, 1 Mild, 2 Moderate, 3 Severe for each parameters evaluated.
Measured: Up to day 7
Vital Signs (Blood Pressure)
Subjects blood pressure will be measured by the Investigator or his/her deputy
Measured: Up to day 7
Vital Signs (Heart Rate)
Subjects heart rate will be measured by the Investigator or his/her deputy
Measured: Up to day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start16 Jun 2020
- Primary completion13 Oct 2020
- Study completion20 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sintetica SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Milko Radicioni, Principal investigator, CROSS Research S.A., Phase I Clinical Unit, Arzo, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04779606
- Sponsor's protocol ID
- CHL.3-01-2020
- Status last verified
- Jun 2021
- First submitted
- 19 Jan 2021
- Last updated
- 16 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Randomized, Placebo-controlled, Double-masked, Efficacy, Safety and Local Tolerability Study of Chloroprocaine 3% Gel Eye Drops in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04779606
- Acronym / sponsor ID
- CHL.3-01-2020
- Conditions
- Healthy Subjects
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Sintetica SAIndustry (pharma, biotech, devices)
- Study start
- 16 Jun 2020 (actual)
- Primary completion
- 13 Oct 2020 (actual)
- Study completion
- 20 Oct 2020 (actual)
- First posted
- 3 Mar 2021 (actual)
- Results
- Posted 16 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study evaluate the efficacy, safety and local tolerability of Chloroprocaine 3% ophthalmic gel as compared to matching placebo in healthy subjects.
Detailed description
One hundred and five (105) healthy male and female subjects will be randomised in a 4:1 ratio to receive a single ocular instillation of Chloroprocaine 3% ophthalmic gel or matching placebo (vehicle) (84 subjects will receive chloroprocaine and 21 subjects will receive placebo). The assigned investigational product (3 drops) will be instilled in the right eye of each subject. Administrations will be performed at the clinical centre by the Investigator or his deputy on study day 1. For each administration, the 3 drops will be instilled at a 1 min ± 15 sec interval.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chloroprocaine | Experimental | Drug: Ocular gelChloroprocaine 3% ocular gel (30 mg/mL), 3 drops instilled at a 1 min ± 15 sec interval. |
| Placebo | Placebo comparator | Drug: Ocular gelVehicle for chloroprocaine 3% ocular gel, 3 drops instilled at a 1 min ± 15 sec interval. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Informed consent: Signed written informed consent before inclusion in the study
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ocular gelAlso: No other intervention names3 drops instilled in the right eye | Drug | Chloroprocaine, Placebo |
Primary outcome
Number of Participants Gaining Full Conjunctival Anesthesia of the Ocular Surface
Time frame: Day 1
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)
10 secondary outcomes
Time to Anesthesia, Evaluated by Conjunctiva Pinching (0.3-mm Forceps) - Only Study Eye (Right Eye)
Time frame: Day 1
Duration of Anesthesia - Only Right Eye
Time frame: Day 1
Visual Acuity (EDTRS Chart) - Both Eyes
Time frame: Up to day 7
Ocular Symptoms
Time frame: Up to day 7
Ocular Signs by Slit Lamp Examination
Time frame: Up to day 7
Corneal Fluorescein Staining by Slit Lamp Examination - Both Eyes
Time frame: Up to day 7
Intraocular Pressure (IOP) - Both Eyes
Time frame: Up to day 7
Fundus Ophthalmoscopy (Vitreous, Macula, Retina and Optic Nerve Head) With the Slit Lamp - Both Eyes
Time frame: Up to day 7
Vital Signs (Blood Pressure)
Time frame: Up to day 7
Vital Signs (Heart Rate)
Time frame: Up to day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Milko Radicioni principal investigator
CROSS Research S.A., Phase I Clinical Unit, Arzo, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ocular gel in people with Healthy Subjects, run by Sintetica SA at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Gaining Full Conjunctival Anesthesia of the Ocular Surface (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.