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Chloroprocaine 3% Gel Eye Drop as Topical Anestheticsin Phacoemulsification.

Primary Purpose

Cataract

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Chloroprocaine 3%

Tetracaine 0.5%

About this trial

This is an interventional treatment trial for Cataract focused on measuring Cataract, Eye, Chloroprocaine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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)

Exclusion Criteria:

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
Patient already included in the study for phakoexeresis
History of ophthalmic surgical complication (cystoid macular oedema, etc.)
Diabetes mellitus
Surdity
Pakinsondisease
Excessive anxiety
Any other medical or surgical history, disorder or disease such as acute or chronic severe organic disease: hepatic, endocrine neoplasic, hematological diseases, severe psychiatric illness, relevant cardiovascular abnormalities (such as unstable angina, bradycardia, atrial fibrillation,uncontrolled hypertension: systolic blood pressure over 140 mm Hg, diastolic blood pressure over 90 mmHg) and/or any complicating factor or structural abnormality judged by the investigator to be incompatible with the study.
Known hypersensitivity to sulfonamides products or any of the components of the study medications or to test products Specific exclusion criteria for women
Pregnancy (positive pregnancy test), lactation
Women of childbearing potential without an acceptable effective method of contraception (oral contraceptive, intra-uterine device, subcutaneous contraceptive implant) until end of the study participation OR
Women not hysterectomized, not menopaused nor surgically sterilized. Exclusion criteria related to general conditions
Inability of patient and/or relatives to understand the study procedures and thus inability to give informed consent
Non-compliant patient and/or relatives (e.g. not willing to attend the follow-up visits, way of life interfering with compliance)
Participation in anotherclinicalstudy
Already included once in this study
Ward of court
Patient not covered by the Social Security

Sites / Locations

Policlinico S. Orsola-Malpighi - Dipartimento testa collo, U.O. Oftalmologia Ciardella
A.O. Mater Domini di Catanzaro - U.O. Oculistica
A.O.U. Careggi di Firenze - Dipartimento neuromuscoloscheletrico e organi di senso, reparto di oculistica
"IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano" - Dipartimento di chirurgia, U.O. Oculistica
Gruppo Multimedica Ospedale San Giuseppe di Milano - Clinica oculistica
Ospedale San Raffaele IRCCS - Clinica oculistica
ASST Santi Paolo e Carlo - Presidio Ospedale San Paolo - Dipartimento testa collo, reparto di oculistica
Fondazione IRCCS Policlinico S. Matteo - Dipartimento di scienze chirurgiche, U.O. Oculistica
A.O. di Perugia - Ospedale S. Maria della Misericordia di Perugia - Clinica oculistica
A.O.U. Pisana - Cisanello - D.A.I. Specialità chirurgiche, U.O. Oculistica
Policlinico Universitario Campus Bio-medico di Roma - U.O.C. Oftalmologia
Fondazione PTV Policlinico Tor Vergata - Dipartimento benessere della salute mentale e neurologica, dentale e degli organi di senso, U.O.S.D. Oculistica
Ospedale Oftalmico di Roma (ASL Roma 1) - Dipartimento di oculistica e rete oftalmologica
IRCCS Fondazione G.B. Bietti di Roma - U.O.S. Segmento anteriore con annessi oculari
A.O.U. Senese - Università degli Studi di Siena - Dipartimento della salute mentale e degli organi di senso, U.O.C. Oculistica
Az. Sanitaria Universitaria Integrata di Udine - P.O. Universitario "Santa Maria della Misericordia" - Dipartimento di chirurgia specialistica, clinica oculistica
Izak Vision Center s.r.o.
FNsP F. D. Roosevelta Banská Bystrica II. Očná klinika SZU
ROBIN LOOK spol. s r.o., Centrum mikrochirurgie oka
Vesely Očná Klinika, s.r.o.
3F s.r.o. Očná ambulancia a optika
UVEA KLINIKA, s.r.o.
VIDISSIMO s. r. o. Očná klinika
Fakultná nemocnica s poliklinikou Žilina Očné oddelenie
Oftalvist Cio Jerez Clinic
Vissum alicante
Instituto Oftalmológico Integral Servicio de Oftalmología Admiravisión en Clínica Corachan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Chloroprocaine 3%

Tetracaine 0.5%

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Changes in Ocular Symptoms

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

Objective Ocular Signs

- 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

Fluoresceine

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).

Endothelial Cell Counts

Modification of the basal status of the Endothelial cell counts evaluated with the specular microscopy

Corneal Thickness

Modification of the basal status of the assesment (Corneal thickness). Measurement of the central corneal thickness was to be performed with a pachymeter

Best Far Corrected Visual Acuity

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.

Number of Participants With Abnormalities of the Retina, Macula, or Optic Nerve by Fundoscopy

Modification of the basal status of the assesment. Dilated fundus examination on retina, macula, optic nerve.

Intra-ocular Pressure

Modification of the basal status of the assesment. Intraocular pressure (in mmHg) was assessed according to site current practice (air puff or applanation tonometer).

Surgeon Satisfaction

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.

Patient Global Satisfaction

Patient global satisfaction at D1 based on a 5-question questionnaire read by a masked observer. A question read by a masked observer assessed the patient satisfaction about the overall anesthesia during the surgery: "Overall, how satisfied are you with the topical study product used for your local anesthesia during your cataract surgery?" It was measured with 5 possible answers (Likert satisfaction scale): Very satisfied (0), Globally satisfied (1), Neither satisfied nor Unsatisfied (2), Globally unsatisfied (3), Very unsatisfied (4). It was measured at Visit 3.

Full Information

NCT ID

NCT04685538

First Posted

December 15, 2020

Last Updated

January 16, 2023

Sponsor

Sintetica SA

1. Study Identification

Unique Protocol Identification Number

NCT04685538

Brief Title

Chloroprocaine 3% Gel Eye Drop as Topical Anestheticsin Phacoemulsification.

Official Title

A Prospective, Observer-masked, Randomized Clinical Trial to Investigate and Compare the Clinical Efficacy of Chloroprocaine 3% Gel and Tetracaine 0.5% Eye Drop as Topical Anestheticsin Phacoemulsification.

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

September 9, 2020 (Actual)

Primary Completion Date

March 1, 2021 (Actual)

Study Completion Date

March 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sintetica SA

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

Prospective,randomized, multi-center, active-controlled, masked-observer, parallel-group, competitive equivalence study. The study has been designed to assess the equivalence of chloroprocaine 3% gel (Test) with respect to tetracaine 0.5% solution (Reference) in surface anesthesia. Patients in both groups will receive three drops of study products before surgery. The study will include a Selection visit (Day -90/Day -1), an Inclusion visit (Day 1/surgery day), a Follow-up visit (Day 2, phone visit), a Final visit (Day 8), and a Follow-up phone call - Optional (Day 28, phone visit). Selection visit (Visit 1, Day -90/Day -1): Patients scheduled to undergo cataract surgery in a single eye will be informed about the aims, procedures and possible risks of the study and will be asked to sign the informed consent form for the inclusion in the trial. Inclusion visit/Surgery (Visit 2, Day 1): Before the anesthesia, patients will be questioned about previous and concomitant ocular and non-ocular treatments. Inclusion /exclusion criteria and patient status will be verified. Patients will be randomized to either chloroprocaine 3% gel (Test) or tetracaine 0.5% eye drop (Reference) treatment group. Follow-up visit/phone visit (Visit 3, Day 2): Concomitant ocular and non-ocular treatments, AEs, and patient global satisfaction will be assessed. Final visit (Visit 4, Day 8 ± 1 day): Concomitant ocular and non-ocular treatments, ocular symptoms, best far corrected visual acuity in both eyes, endothelial cell count, corneal thickness, blood pressure and heart rate, and AEs will be assessed. Slit lamp examination and fluorescein test, IOP in both eyes, and fundoscopy will be performed. Optional visit/phone visit (Visit 5, Day 28 ± 3 days): Concomitant ocular and non-ocular treatments and AEs resolution will be assessed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cataract

Keywords

Cataract, Eye, Chloroprocaine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

338 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Chloroprocaine 3%

Arm Type

Experimental

Arm Description

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

Arm Title

Tetracaine 0.5%

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Chloroprocaine 3%

Other Intervention Name(s)

Arm 1

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Tetracaine 0.5%

Other Intervention Name(s)

Arm 2

Intervention Description

Primary Outcome Measure Information:

Title

Number of Participants in Each Treatment Group With a Successful Surface Anesthesia

Description

Time Frame

Before Intra Ocular Lens (IOL) implantation surgery.

Secondary Outcome Measure Information:

Title

Changes in Ocular Symptoms

Description

Time Frame