Chloroprocaine 3% Gel Eye Drop as Topical Anestheticsin Phacoemulsification.

NCT ID: NCT04685538

Last Updated: 2023-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 338 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-09
• Study Completion Date: 2021-03-09

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.

Conditions

Cataract

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Chloroprocaine 3%

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

Group Type: EXPERIMENTAL

Chloroprocaine 3%

Intervention Type: 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.

Tetracaine 0.5%

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

Group Type: ACTIVE_COMPARATOR

Tetracaine 0.5%

Intervention Type: 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.

Interventions

Chloroprocaine 3%

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

Tetracaine 0.5%

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

Other Intervention Names

Arm 1; Arm 2

Eligibility Criteria

Inclusion Criteria

1. Signed and dated informed consent

2. Male or female aged≥ 18 years

3. Senile or pre-senile cataract

4. 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

1. Combined surgery

2. Previous intraocular surgery

3. Previous corneal refractive surgeries less than 6 months before screening

4. Non Senile or non pre-senilecataract (e.g.: traumatic, pathological or congenital cataract)

5. Pupillary abnormalities (irregular, etc.)

6. Iris synechiae

7. Eye movement disorder (nystagmus, etc.)

8. Dacryocystitis and all other pathologies of tears drainage system

9. History of Inflammatory ocular disease (Iritis, uveitis, herpetic keratitis)

10. Corneal, epithelial, stromal or endothelial, residual or evolutionary disease (including corneal ulceration and superficial punctuate keratitis)

11. History of ocular traumatism, infection or inflammation within the last 3 months

12. Pseudo-exfoliation, exfoliative syndrome

13. Prior intravitreal injections within 7 days of the surgery

14. IOP over 25mmHg under treatment

15. Best corrected visual acuity < 1/10

16. Patient already included in the study for phakoexeresis

17. History of ophthalmic surgical complication (cystoid macular oedema, etc.)

18. Diabetes mellitus

19. Surdity

20. Pakinsondisease

21. Excessive anxiety

22. 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.

24. Pregnancy (positive pregnancy test), lactation

25. 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

27. Inability of patient and/or relatives to understand the study procedures and thus inability to give informed consent

28. Non-compliant patient and/or relatives (e.g. not willing to attend the follow-up visits, way of life interfering with compliance)

29. Participation in anotherclinicalstudy

30. Already included once in this study

31. Ward of court

32. Patient not covered by the Social Security

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sintetica SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jorge Alio, MD

Role: PRINCIPAL_INVESTIGATOR

Vissum Alicante, Calle del Cabañal 1, 03016 Alicante, Spain

Locations

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

Bologna, , Italy

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

Catanzaro, , Italy

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

Florence, , Italy

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

Milan, , Italy

Gruppo Multimedica Ospedale San Giuseppe di Milano - Clinica oculistica

Milan, , Italy

Ospedale San Raffaele IRCCS - Clinica oculistica

Milan, , Italy

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

Milan, , Italy

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

Pavia, , Italy

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

Perugia, , Italy

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

Pisa, , Italy

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

Roma, , Italy

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

Roma, , Italy

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

Roma, , Italy

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

Roma, , Italy

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

Siena, , Italy

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

Udine, , Italy

Izak Vision Center s.r.o.

Banská Bystrica, , Slovakia

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

Banská Bystrica, , Slovakia

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

Bratislava, , Slovakia

Vesely Očná Klinika, s.r.o.

Bratislava, , Slovakia

3F s.r.o. Očná ambulancia a optika

Košice, , Slovakia

UVEA KLINIKA, s.r.o.

Martin, , Slovakia

VIDISSIMO s. r. o. Očná klinika

Trenčín, , Slovakia

Fakultná nemocnica s poliklinikou Žilina Očné oddelenie

Žilina, , Slovakia

Oftalvist Cio Jerez Clinic

Jerez de la Frontera, Cadiz, Spain

Vissum alicante

Alicante, , Spain

Instituto Oftalmológico Integral Servicio de Oftalmología Admiravisión en Clínica Corachan

Barcelona, , Spain

Countries

Italy; Slovakia; Spain

References

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.

Reference Type: DERIVED

PMID: 38489057 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CHL.3/01-2019/M

Identifier Type: -

Identifier Source: org_study_id