Clinical trial NCT04685538: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cataract
Keywords: Cataract
Eye
Chloroprocaine
Lead sponsor: Sintetica SA
Sponsor class: INDUSTRY
First posted: 2020-12-28
Enrollment: 338
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.
23. Known hypersensitivity to sulfonamides products or any of the components of the study medications or to test products Specific exclusion criteria for women
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
26. Women not hysterectomized, not menopaused nor surgically sterilized. Exclusion criteria related to general conditions
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

Primary outcomes:
measure: Number of Participants in Each Treatment Group With a Successful Surface Anesthesia
timeFrame: Before Intra Ocular Lens (IOL) implantation surgery.
Secondary outcomes:
measure: Changes in Ocular Symptoms
timeFrame: Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days
measure: Objective Ocular Signs
timeFrame: Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days
measure: Fluoresceine
timeFrame: Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days
measure: Endothelial Cell Counts
timeFrame: Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days
measure: Corneal Thickness
timeFrame: Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days
measure: Best Far Corrected Visual Acuity
timeFrame: Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days
measure: Number of Participants With Abnormalities of the Retina, Macula, or Optic Nerve by Fundoscopy
timeFrame: Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days
measure: Intra-ocular Pressure
timeFrame: Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days
measure: Surgeon Satisfaction
timeFrame: day 1 - visit2 (Inclusion visit/Surgery)
measure: Patient Global Satisfaction
timeFrame: day 1 - visit2 (Inclusion visit/Surgery) after the treatment
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Policlinico S. Orsola-Malpighi - Dipartimento testa collo, U.O. Oftalmologia Ciardella
city: Catanzaro
country: Italy
facility: A.O. Mater Domini di Catanzaro - U.O. Oculistica
city: Firenze
country: Italy
facility: A.O.U. Careggi di Firenze - Dipartimento neuromuscoloscheletrico e organi di senso, reparto di oculistica
city: Milano
country: Italy
facility: "IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano" - Dipartimento di chirurgia, U.O. Oculistica
city: Milano
country: Italy
facility: Gruppo Multimedica Ospedale San Giuseppe di Milano - Clinica oculistica
city: Milano
country: Italy
facility: Ospedale San Raffaele IRCCS - Clinica oculistica
city: Milano
country: Italy
facility: ASST Santi Paolo e Carlo - Presidio Ospedale San Paolo - Dipartimento testa collo, reparto di oculistica
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico S. Matteo - Dipartimento di scienze chirurgiche, U.O. Oculistica
city: Perugia
country: Italy
facility: A.O. di Perugia - Ospedale S. Maria della Misericordia di Perugia - Clinica oculistica
city: Pisa
country: Italy
facility: A.O.U. Pisana - Cisanello - D.A.I. Specialità chirurgiche, U.O. Oculistica
city: Roma
country: Italy
facility: Policlinico Universitario Campus Bio-medico di Roma - U.O.C. Oftalmologia
city: Roma
country: Italy
facility: Fondazione PTV Policlinico Tor Vergata - Dipartimento benessere della salute mentale e neurologica, dentale e degli organi di senso, U.O.S.D. Oculistica
city: Roma
country: Italy
facility: Ospedale Oftalmico di Roma (ASL Roma 1) - Dipartimento di oculistica e rete oftalmologica
city: Roma
country: Italy
facility: IRCCS Fondazione G.B. Bietti di Roma - U.O.S. Segmento anteriore con annessi oculari
city: Siena
country: Italy
facility: A.O.U. Senese - Università degli Studi di Siena - Dipartimento della salute mentale e degli organi di senso, U.O.C. Oculistica
city: Udine
country: Italy
facility: Az. Sanitaria Universitaria Integrata di Udine - P.O. Universitario "Santa Maria della Misericordia" - Dipartimento di chirurgia specialistica, clinica oculistica
city: Banská Bystrica
country: Slovakia
facility: Izak Vision Center s.r.o.
city: Banská Bystrica
country: Slovakia
facility: FNsP F. D. Roosevelta Banská Bystrica II. Očná klinika SZU
city: Bratislava
country: Slovakia
facility: ROBIN LOOK spol. s r.o., Centrum mikrochirurgie oka
city: Bratislava
country: Slovakia
facility: Vesely Očná Klinika, s.r.o.
city: Košice
country: Slovakia
facility: 3F s.r.o. Očná ambulancia a optika
city: Martin
country: Slovakia
facility: UVEA KLINIKA, s.r.o.
city: Trenčín
country: Slovakia
facility: VIDISSIMO s. r. o. Očná klinika
city: Žilina
country: Slovakia
facility: Fakultná nemocnica s poliklinikou Žilina Očné oddelenie
city: Jerez de la Frontera
country: Spain
facility: Oftalvist Cio Jerez Clinic
state: Cadiz
city: Alicante
country: Spain
facility: Vissum alicante
city: Barcelona
country: Spain
facility: Instituto Oftalmológico Integral Servicio de Oftalmología Admiravisión en Clínica Corachan
Study officials:
affiliation: Vissum Alicante, Calle del Cabañal 1, 03016 Alicante, Spain
name: Jorge Alio, MD
role: PRINCIPAL_INVESTIGATOR
References: