NCT04753710 is a Phase 2, PHASE3 clinical trial of Ocular gel in Healthy Volunteers, sponsored by Sintetica SA.

Who is sponsoring NCT04753710?

NCT04753710 is sponsored by Sintetica SA.

What drugs are being tested in NCT04753710?

Interventions in NCT04753710: Ocular gel.

What condition does NCT04753710 study?

NCT04753710 studies Healthy Volunteers.

Is NCT04753710 still recruiting?

NCT04753710 is currently completed. Last updated 17 March 2022.

Are results published for NCT04753710?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-03-17 · How we verify

NCT04753710

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2, PHASE3 Results posted Last updated 17 March 2022

What this trial tests

Phase 2, PHASE3 trial testing Ocular gel in Healthy Volunteers in 96 participants. Completed in 9 December 2020.

Timeline

29 June 2020

Primary endpoint
6 November 2020

9 December 2020

Quick facts

Lead sponsor	Sintetica SA
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	96
Start date	29 June 2020
Primary completion	6 November 2020
Estimated completion	9 December 2020
Sites	1 location across Austria

Drugs / interventions tested

Ocular gel — full drug profile →

Conditions studied

Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

Sintetica SA — full company profile →

Who can join

Adults 18 to 90, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants in Phase 2 With Anesthesia Success Primary · 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)

Anesthesia success

Group	Value	95% CI
Chloroprocaine	38
Placebo	4

No success

Group	Value	95% CI
Chloroprocaine	2
Placebo	16

Duration of Anesthesia Only in Patients in Phase 2 Secondary · Day 1

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)

Group	Value	95% CI
Chloroprocaine	24.15	± 8.83
Placebo	19.3	± 14.72

Number of Participants With Adverse Events Secondary · Up to 29 days

Number of Participants with Ocular symptoms and Adverse events

Group	Value	95% CI
Chloroprocaine	43
Placebo	15

Mean Arterial Pressure Secondary · up to 8 days

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).

Visit 1 Screening

Group	Value	95% CI
Chloroprocaine	95	± 9
Placebo	94	± 9

Visit 2 pre-dose

Group	Value	95% CI
Chloroprocaine	96	± 8
Placebo	94	± 9

Visit 2 post-dose

Group	Value	95% CI
Chloroprocaine	95	± 8
Placebo	92	± 9

Visit 4 Follow-up

Group	Value	95% CI
Chloroprocaine	95	± 8
Placebo	94	± 9

Number of Participants With Anomalies in Slip Lamp Examination Secondary · up to 8 days

Number of Participants with Anomalies in Slip Lamp Examination

Group	Value	95% CI
Chloroprocaine	17
Placebo	5

Number of Participants With Anomalies in Corneal Fluorescein Staining Secondary · up to 8 days

Number of Participants with anomalies found with corneal fluorescein staining

Group	Value	95% CI
Chloroprocaine	0
Placebo	0

Ocular Pressure Secondary · Follow up (up to 8 days)

Intraocular pressure (mmHg)

screening

Group	Value	95% CI
Chloroprocaine	14	± 2.6
Placebo	14	± 2.3

follow up

Group	Value	95% CI
Chloroprocaine	13.6	± 2.6
Placebo	13.3	± 2

Adverse events — posted to ClinicalTrials.gov

Time frame: Study duration (Up to 29 days). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Chloroprocaine

Serious: 0/67 (0%)

Deaths: 0/67

Placebo

Serious: 0/29 (0%)

Deaths: 0/29

Other adverse events (27 terms — click to expand)

Reaction	System	Chloroprocaine	Placebo
mydriasis	Eye disorders	—	—
eye irritation	Eye disorders	—	—
bradycardia	Cardiac disorders	—	—
Headache	Nervous system disorders	—	—
vision blurred	Eye disorders	—	—
Sensation of foreign body	General disorders	—	—
Conjunctival hemorrhage	Eye disorders	—	—
Nasopharyngitis	Infections and infestations	—	—
Dysmenorrhea	Reproductive system and breast disorders	—	—
pruritus	Skin and subcutaneous tissue disorders	—	—
Conjunctival edema	Eye disorders	—	—
dry eye	Eye disorders	—	—
ocular hyperemia	Eye disorders	—	—
Abdominal discomfort	Gastrointestinal disorders	—	—
Abdominal pain	Gastrointestinal disorders	—	—
nausea	Gastrointestinal disorders	—	—
fatigue	General disorders	—	—
instillation site pain	General disorders	—	—
pain	General disorders	—	—
Covid-19	Infections and infestations	—	—
Rhinitis	Infections and infestations	—	—
tonsillitis	Infections and infestations	—	—
ligament sprain	Injury, poisoning and procedural complications	—	—
Intraocular pressure increased	Investigations	—	—
Sars-cov-2 test positive	Investigations	—	—
presyncope	Nervous system disorders	—	—
syncope	Nervous system disorders	—	—

Data from ClinicalTrials.gov NCT04753710 adverse events section.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Ocular gel

Trials testing the same drug.

NCT04779606 — Efficacy, Safety and Local Tolerability Study of Chloroprocaine 3% Gel Eye Drops in Healthy Volunteers · Phase 1, PHASE2 · completed

Other recruiting trials for Healthy Volunteers

Currently open trials in the same condition.

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NCT07495813 — A Study to See How RO7763505 Works and How Safe it is When Given to Healthy People and People With Stable Heart Disease · Phase 1 · recruiting
NCT07499050 — A Study of Multiple Doses of Orally Administered RO7795081 in Otherwise Healthy Chinese Adult Participants With Obesity · Phase 1 · recruiting
NCT07342114 — A Dose-Escalation Study of RO7875913 in Healthy Participants · Phase 1 · recruiting

Other Sintetica SA trials

Trials by the same sponsor.

NCT05926258 — Efficacy and Safety of Chloroprocaine 3% Gel and Oxybuprocaine 0.4% Eye Drops Anesthesia in Pediatric Population · Phase 3 · completed
NCT04685538 — Chloroprocaine 3% Gel Eye Drop as Topical Anestheticsin Phacoemulsification. · Phase 3 · completed
NCT04779606 — Efficacy, Safety and Local Tolerability Study of Chloroprocaine 3% Gel Eye Drops in Healthy Volunteers · Phase 1, PHASE2 · completed
NCT03918798 — The Efficacy and Safety of Chloroprocaine 1% and 2% in Pediatric Population · Phase 2 · completed
NCT03428230 — Intrathecal Paracetamol Before Spinal Anaesthesia With Chloroprocaine HCl 1% for Short Knee Procedures · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04753710 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sintetica SA
Last refreshed: 17 March 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04753710.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing