Healthy VolunteersPhase 2/3NCT04753710
Efficacy, Safety and Tolerability Study of Chloroprocaine 3% Gel Eye Drops in Healthy Volunteers
A Phase 2/3 study testing Ocular gel in people with Healthy Volunteers, run by Sintetica SA at 1 site in Austria.
Trial summary
The study assess efficacy, safety and tolerability of Chloroprocaine 3% ophthalmic gel in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Ocular gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteAustria
- Study dates
- 29 Jun 2020to 9 Dec 2020
- Phase
- Phase 2/3
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Ophthalmic exclusion criteria
- 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
Show all 27Show fewer
- Best corrected visual acuity < 1/10
- History of ophthalmic surgical complication (i.e. cystoid macular oedema)
- Systemic/non ophthalmic exclusion criteria
- General history:
- 8.1 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
- Specific non-inclusion criteria for women:
- 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
- Non-compliant subject (e.g. not willing to attend the follow-up visits, way of life interfering with compliance)
- Participation in another clinical study
- Already included once in this study
- Ward of court
- Subject not covered by the Social Security
- Exclusion criteria related to previous and concomitant medications (taken within 15 days prior screening visit)
- Use of systemic opioids and opioid drugs
- Topical ocular treatment with anaesthetic action
- Use of systemic analgesic drugs (except paracetamol, which will be allowed after Visit 2)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Volunteers
- 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
Instillation
| Study group | Role | What they receive |
|---|---|---|
| Chloroprocaine | Experimental | Chloroprocaine 3% ocular gel Receives: Drug: Ocular gel |
| Placebo | Placebo comparator | Vehicle for chloroprocaine 3% ocular gel Receives: Drug: Ocular gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Day 1
Secondary outcomes (6)
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)
Measured: Day 1
Number of Participants With Adverse Events
Number of Participants with Ocular symptoms and Adverse events
Measured: 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).
Measured: up to 8 days
Number of Participants With Anomalies in Slip Lamp Examination
Number of Participants with Anomalies in Slip Lamp Examination
Measured: up to 8 days
Number of Participants With Anomalies in Corneal Fluorescein Staining
Number of Participants with anomalies found with corneal fluorescein staining
Measured: up to 8 days
Ocular Pressure
Intraocular pressure (mmHg)
Measured: Follow up (up to 8 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start29 Jun 2020
- Primary completion6 Nov 2020
- Study completion9 Dec 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 VolunteersStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sintetica SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gerhard Garhoefer, Principal investigator, Universitätsklinik für Klinische Pharmakologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04753710
- Sponsor's protocol ID
- CHL.3-02-2019
- Status last verified
- Jan 2021
- First submitted
- 19 Jan 2021
- Last updated
- 17 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II/III, Randomized, Double-Masked, Vehicle-Controlled, Efficacy, Safety and Tolerability Study of Chloroprocaine 3% Gel Eye Drops in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04753710
- Acronym / sponsor ID
- CHL.3-02-2019
- Conditions
- Healthy Volunteers
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Sintetica SAIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2020 (actual)
- Primary completion
- 6 Nov 2020 (actual)
- Study completion
- 9 Dec 2020 (actual)
- First posted
- 15 Feb 2021 (actual)
- Results
- Posted 24 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 |
| Placebo | Placebo comparator | Drug: Ocular gelVehicle for chloroprocaine 3% ocular gel |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (27 listed)
- Ophthalmic exclusion criteria
- 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)
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 gelInstillation | Drug | Chloroprocaine, Placebo |
Primary outcome
Number of Participants in Phase 2 With Anesthesia Success
Time frame: 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)
6 secondary outcomes
Duration of Anesthesia Only in Patients in Phase 2
Time frame: Day 1
Number of Participants With Adverse Events
Time frame: Up to 29 days
Mean Arterial Pressure
Time frame: up to 8 days
Number of Participants With Anomalies in Slip Lamp Examination
Time frame: up to 8 days
Number of Participants With Anomalies in Corneal Fluorescein Staining
Time frame: up to 8 days
Ocular Pressure
Time frame: Follow up (up to 8 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Screening Protocol
Pain
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.
Gerhard Garhoefer principal investigator
Universitätsklinik für Klinische Pharmakologie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ocular gel in people with Healthy Volunteers, run by Sintetica SA at 1 site in Austria.
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 5 inclusion and 27 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 17 Mar 2022. 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 Austria. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 24 Jan 2022). 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 in Phase 2 With Anesthesia Success (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 17 Mar 2022.