NCT04685538

Brief Summary

Randomized clinical trial, multicenter, two-armed, to investigate and compare the clinical efficacy of chloroprocaine 3% gel and tetracaine 0.5% eye drop as topical anestheticsin phacoemulsification. This prospective, observer masked, randomised, controlled, equivalence phase 3 study will be conducted in approximately 4 European Countries. Sintetica intends to perform a phase 3 study on patients undergoing cataract surgery to assess the safety and efficacy of topical anaesthesia using chloroprocaine gel.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
338

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2020

Shorter than P25 for phase_3

Geographic Reach
3 countries

27 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 9, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 28, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2021

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

October 27, 2022

Completed
Last Updated

January 18, 2023

Status Verified

April 1, 2021

Enrollment Period

6 months

First QC Date

December 15, 2020

Results QC Date

October 19, 2021

Last Update Submit

January 16, 2023

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

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 2
Tetracaine 0.5%

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
  • Senile or pre-senile cataract
  • Scheduled to undergo cataract surgery in a single eyeat a time (clear corneal self-sealing incisions - phacoemulsification - foldable intra-ocular lens surgery with injector)

You may not qualify if:

  • Combined surgery
  • Previous intraocular surgery
  • Previous corneal refractive surgeries less than 6 months before screening
  • Non Senile or non pre-senilecataract (e.g.: traumatic, pathological or congenital cataract)
  • Pupillary abnormalities (irregular, etc.)
  • Iris synechiae
  • Eye movement disorder (nystagmus, etc.)
  • 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
  • Pseudo-exfoliation, exfoliative syndrome
  • Prior intravitreal injections within 7 days of the surgery
  • IOP over 25mmHg under treatment
  • Best corrected visual acuity \< 1/10
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

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

Bologna, 40138, Italy

Location

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

Catanzaro, 88100, Italy

Location

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

Florence, 50134, Italy

Location

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

Milan, 20122, Italy

Location

Gruppo Multimedica Ospedale San Giuseppe di Milano - Clinica oculistica

Milan, 20123, Italy

Location

Ospedale San Raffaele IRCCS - Clinica oculistica

Milan, 20123, Italy

Location

ASST Santi Paolo e Carlo - Presidio Ospedale San Paolo - Dipartimento testa collo, reparto di oculistica

Milan, 20142, Italy

Location

Fondazione IRCCS Policlinico S. Matteo - Dipartimento di scienze chirurgiche, U.O. Oculistica

Pavia, 27100, Italy

Location

A.O. di Perugia - Ospedale S. Maria della Misericordia di Perugia - Clinica oculistica

Perugia, 06129, Italy

Location

A.O.U. Pisana - Cisanello - D.A.I. Specialità chirurgiche, U.O. Oculistica

Pisa, 56126, Italy

Location

Policlinico Universitario Campus Bio-medico di Roma - U.O.C. Oftalmologia

Roma, 00128, Italy

Location

Fondazione PTV Policlinico Tor Vergata - Dipartimento benessere della salute mentale e neurologica, dentale e degli organi di senso, U.O.S.D. Oculistica

Roma, 00133, Italy

Location

Ospedale Oftalmico di Roma (ASL Roma 1) - Dipartimento di oculistica e rete oftalmologica

Roma, 00136, Italy

Location

IRCCS Fondazione G.B. Bietti di Roma - U.O.S. Segmento anteriore con annessi oculari

Roma, 00198, Italy

Location

A.O.U. Senese - Università degli Studi di Siena - Dipartimento della salute mentale e degli organi di senso, U.O.C. Oculistica

Siena, 53100, Italy

Location

Az. Sanitaria Universitaria Integrata di Udine - P.O. Universitario "Santa Maria della Misericordia" - Dipartimento di chirurgia specialistica, clinica oculistica

Udine, 33100, Italy

Location

Izak Vision Center s.r.o.

Banská Bystrica, 974 01, Slovakia

Location

FNsP F. D. Roosevelta Banská Bystrica II. Očná klinika SZU

Banská Bystrica, 975 17, Slovakia

Location

ROBIN LOOK spol. s r.o., Centrum mikrochirurgie oka

Bratislava, 821 03, Slovakia

Location

Vesely Očná Klinika, s.r.o.

Bratislava, 821 08, Slovakia

Location

3F s.r.o. Očná ambulancia a optika

Košice, 040 11, Slovakia

Location

UVEA KLINIKA, s.r.o.

Martin, 036 01, Slovakia

Location

VIDISSIMO s. r. o. Očná klinika

Trenčín, 911 08, Slovakia

Location

Fakultná nemocnica s poliklinikou Žilina Očné oddelenie

Žilina, 012 07, Slovakia

Location

Oftalvist Cio Jerez Clinic

Jerez de la Frontera, Cadiz, 11408, Spain

Location

Vissum alicante

Alicante, 03016, Spain

Location

Instituto Oftalmológico Integral Servicio de Oftalmología Admiravisión en Clínica Corachan

Barcelona, 08017, Spain

Location

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
aguaita@sintetica.com
+41 (0)91 640 42 50

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

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

Primary Completion

March 1, 2021

Study Completion

March 9, 2021

Last Updated

January 18, 2023

Results First Posted

October 27, 2022

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(16)ES(3)SL(8)