Trial · NCT04685538

Chloroprocaine 3% Gel Eye Drop as Topical Anestheticsin Phacoemulsification.

NCT04685538, Phase 3, Completed, Sintetica SA; results first posted 2022-10-27

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Chloroprocaine 3% Gel Eye Drop as Topical Anestheticsin Phacoemulsification. Trials, record NCT04685538. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04685538

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Chloroprocaine 3% Gel Eye Drop as Topical Anestheticsin Phacoemulsification.
NCT number: NCT04685538
Status: Completed
Phases: Phase 3
Enrollment: 338 participants, actual
Lead sponsor: Sintetica SA
Conditions: Cataract
Interventions: Chloroprocaine 3%, Tetracaine 0.5%
First posted: 2020-12-28
Last updated: 2023-01-18
Results first posted: 2022-10-27

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants in Each Treatment Group With a Successful Surface Anesthesia	Before Intra Ocular Lens (IOL) implantation surgery.	Τhe primary endpoint is the number of partecipants in each treatment group with a successful surface anesthesia, without any supplementation at the time point T4 (1 minute after the 3rd drop installation)
Secondary	Changes in Ocular Symptoms	Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days	Changes in ocular symptoms (pain, irritation/burning/stinging, foreign body sensation) will be graded by the patients according to the following scale (0 is the minimum value and 3 is tha maximum value) (0 = absent, 1 = mild, 2 = moderate, 3 = severe) during the study on Visit 1-selection and on visit 4-final
Secondary	Objective Ocular Signs	Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days	\- Objective ocular signs assessed by slit lamp examination, flare, and other objective ocular signs will be graded according to the following scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe. The minimum value is 0 and maximum value is 3
Secondary	Fluoresceine	Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days	Modification of the basal status evaluated with fluorescein test Approximately 2-3 minutes following fluorescein instillation, corneal staining was to be evaluated in both eyes, using a slit lamp, based on the Oxford scale (grades of 0-5: 0 is normal, 5 is severe abnormal).
Secondary	Endothelial Cell Counts	Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days	Modification of the basal status of the Endothelial cell counts evaluated with the specular microscopy
Secondary	Corneal Thickness	Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days	Modification of the basal status of the assesment (Corneal thickness). Measurement of the central corneal thickness was to be performed with a pachymeter
Secondary	Best Far Corrected Visual Acuity	Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days	Modification of the basal status of the assesment evaluated by LogMAR (Logarithm of the Minimum Angle of Resolution). When using a LogMAR chart, visual acuity is scored with reference to the logarithm of the minimum angle of resolution, as the chart's name suggests. 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.
Secondary	Number of Participants With Abnormalities of the Retina, Macula, or Optic Nerve by Fundoscopy	Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days	Modification of the basal status of the assesment. Dilated fundus examination on retina, macula, optic nerve.
Secondary	Intra-ocular Pressure	Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days	Modification of the basal status of the assesment. Intraocular pressure (in mmHg) was assessed according to site current practice (air puff or applanation tonometer).
Secondary	Surgeon Satisfaction	day 1 - visit2 (Inclusion visit/Surgery)	Evaluation of surgeon satisfaction. Surgeon satisfaction was assessed through the question "How do you consider the study product global tolerance?", at a scale (a score of 0 is the minimum value with the best outcome and 3 is the maximum value with the worst outcome): (0) Very satisfactory, (1) Satisfactory, (2) Not very satisfactory, (3) Unsatisfactory. It is recorded at V2 and filled in by the surgeon who had performed the study. It is measured at Visit 2.

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Number of Participants in Each Treatment Group With a Successful Surface Anesthesia	Before Intra Ocular Lens (IOL) implantation surgery.	participants	NUMBER
SECONDARY	Changes in Ocular Symptoms	Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days	score on a scale	MEAN
SECONDARY	Objective Ocular Signs	Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days	score on a scale	MEAN
SECONDARY	Fluoresceine	Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days	score on a scale	MEAN
SECONDARY	Endothelial Cell Counts	Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days	cell/mm^2	MEAN
SECONDARY	Corneal Thickness	Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days	um	MEAN
SECONDARY	Best Far Corrected Visual Acuity	Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days	LogMAR	MEAN
SECONDARY	Number of Participants With Abnormalities of the Retina, Macula, or Optic Nerve by Fundoscopy	Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Intra-ocular Pressure	Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days	mmHg	MEAN
SECONDARY	Surgeon Satisfaction	day 1 - visit2 (Inclusion visit/Surgery)	score on a scale	MEAN

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group60

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Number of Participants in Each Treatment Group With a Successful Surface Anesthesia	Chloroprocaine 3%	Anesthesia Success	153		participants
Number of Participants in Each Treatment Group With a Successful Surface Anesthesia	Tetracaine 0.5%	Anesthesia Success	152		participants
Number of Participants in Each Treatment Group With a Successful Surface Anesthesia	Chloroprocaine 3%	Anesthesia NO Success	14		participants
Number of Participants in Each Treatment Group With a Successful Surface Anesthesia	Tetracaine 0.5%	Anesthesia NO Success	19		participants
Changes in Ocular Symptoms	Chloroprocaine 3%	Foreign Body Sensation visit1	0.08	Standard Deviation 0.32	score on a scale
Changes in Ocular Symptoms	Tetracaine 0.5%	Foreign Body Sensation visit1	0.06	Standard Deviation 0.33	score on a scale
Changes in Ocular Symptoms	Chloroprocaine 3%	Foreign Body Sensation visit4	0.19	Standard Deviation 0.43	score on a scale
Changes in Ocular Symptoms	Tetracaine 0.5%	Foreign Body Sensation visit4	0.17	Standard Deviation 0.41	score on a scale
Changes in Ocular Symptoms	Chloroprocaine 3%	Irritation/Burning/Stinging visit1	0.11	Standard Deviation 0.33	score on a scale
Changes in Ocular Symptoms	Tetracaine 0.5%	Irritation/Burning/Stinging visit1	0.11	Standard Deviation 0.37	score on a scale

1 to 10 of 60Source ClinicalTrials.gov

See all 60 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Chloroprocaine 3%	167
Overall Study	STARTED	Tetracaine 0.5%	171
Overall Study	COMPLETED	Chloroprocaine 3%	167
Overall Study	COMPLETED	Tetracaine 0.5%	168
Overall Study	NOT COMPLETED	Chloroprocaine 3%	0
Overall Study	NOT COMPLETED	Tetracaine 0.5%	3

Source ClinicalTrials.gov

Adverse events52

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	corneal Dystrophy	Congenital, familial and genetic disorders	Chloroprocaine 3%	0	167	0
other	corneal Dystrophy	Congenital, familial and genetic disorders	Tetracaine 0.5%	1	171	1
other	Conjunctival hemorrhage	Eye disorders	Chloroprocaine 3%	1	167	1
other	Conjunctival hemorrhage	Eye disorders	Tetracaine 0.5%	0	171	0
other	congiunctivitis	Eye disorders	Chloroprocaine 3%	0	167	0
other	congiunctivitis	Eye disorders	Tetracaine 0.5%	1	171	1
other	corneal degeneration	Eye disorders	Chloroprocaine 3%	0	167	0
other	corneal degeneration	Eye disorders	Tetracaine 0.5%	1	171	1
other	cornela disorder	Eye disorders	Chloroprocaine 3%	0	167	0
other	cornela disorder	Eye disorders	Tetracaine 0.5%	1	171	1

1 to 10 of 52Source ClinicalTrials.gov

See all 52 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Chloroprocaine 3%	0	167
Total, all-cause mortality	Tetracaine 0.5%	0	171
Total, other adverse events	Chloroprocaine 3%	14	167
Total, other adverse events	Tetracaine 0.5%	19	171
Total, serious adverse events	Chloroprocaine 3%	0	167
Total, serious adverse events	Tetracaine 0.5%	0	171

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
38489057	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Chloroprocaine 3% vs Tetracaine 0.5%: deaths from any cause	Trial comparisons
Chloroprocaine 3% vs Tetracaine 0.5%: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04685538

GET https://conductscience.org/api/trials/v1/NCT04685538/results?page=2

API reference For AI assistants