Trials Sponsors Conditions Drugs Pricing

Conditions

Cataract

Keywords

CataractEyeChloroprocaine

Outcome Measures

Primary Outcomes (1)

Number of Participants in Each Treatment Group With a Successful Surface Anesthesia
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)
Before Intra Ocular Lens (IOL) implantation surgery.

Secondary Outcomes (10)

Changes in Ocular Symptoms
Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days
Objective Ocular Signs
Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days
Fluoresceine
Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days
Endothelial Cell Counts
Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days
Corneal Thickness
Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days
+5 more secondary outcomes

Study Arms (2)

Chloroprocaine 3%

EXPERIMENTAL

All the eligible patients will be administrated by Chloroprocaine 3 % according to the randomization criteria.

Drug: Chloroprocaine 3%

Tetracaine 0.5%

ACTIVE COMPARATOR

All the eligible patients will be administrated by Tetracaine 0.5% according to the randomization criteria.

Drug: Tetracaine 0.5%

Interventions

Chloroprocaine 3%Drug

Administration: three IMP drops instillation as follow: * 1st Drop instillation, then wait for 5 minutes * Eye Disinfection, then wait for 2 minutes * 2nd Drop instillation, then wait for 1 minute * 3rdDrop instillation, then wait for 1 minute * Start of Surgery.

Also known as: Arm 1

Chloroprocaine 3%

Tetracaine 0.5%Drug

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Signed and dated informed consent
Male or female aged≥ 18 years

Sponsors & Collaborators

Sintetica SA
Industrylead

Study Sites (27)

Policlinico S. Orsola-Malpighi - Dipartimento testa collo, U.O. Oftalmologia Ciardella

Bologna, 40138, Italy

A.O. Mater Domini di Catanzaro - U.O. Oculistica

Catanzaro, 88100, Italy

A.O.U. Careggi di Firenze - Dipartimento neuromuscoloscheletrico e organi di senso, reparto di oculistica

Florence, 50134, Italy

"IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano" - Dipartimento di chirurgia, U.O. Oculistica

Milan, 20122, Italy

Gruppo Multimedica Ospedale San Giuseppe di Milano - Clinica oculistica

Milan, 20123, Italy

Ospedale San Raffaele IRCCS - Clinica oculistica

Milan, 20123, Italy

Related Publications (1)

Figus M, Giansanti F, Villani E, Alio JL, Janco L, Mercuri S, Camnasio S, Cagini C. Chloroprocaine 3% Gel as a Novel Ocular Topical Anesthetic: Results from a Multicenter, Randomized Clinical Trial in Patients Undergoing Cataract Surgery. J Ocul Pharmacol Ther. 2024 Mar;40(2):117-125. doi: 10.1089/jop.2023.0096.
PMID: 38489057DERIVED

MeSH Terms

Conditions

Cataract

Interventions

DMAC2L protein, human

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Results Point of Contact

Title: Anna Guaita
Organization: Sintetica SA

Study Officials

Jorge Alio, MD
Vissum Alicante, Calle del Cabañal 1, 03016 Alicante, Spain
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

338 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 15, 2020

First Posted

December 28, 2020

Study Start

September 9, 2020

Actual (reported)

Chloroprocaine 3% Gel Eye Drop as Topical Anestheticsin Phacoemulsification.

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Study Arms (2)

Chloroprocaine 3%

Tetracaine 0.5%

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (27)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Study Arms (2)

Chloroprocaine 3%

Tetracaine 0.5%

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (27)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations