Chloroprocaine 3% Gel Eye Drop as Topical Anestheticsin Phacoemulsification.

Sponsor

Sintetica SA (Industry)

Overall Status

Completed

CT.gov ID

NCT04685538

Collaborator

(none)

342

Enrollment

Locations

Arms

5.9

Actual Duration (Months)

12.7

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Drug: Chloroprocaine 3% Drug: Tetracaine 0.5%	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

342 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Sep 9, 2020

Actual Primary Completion Date :

Mar 1, 2021

Actual Study Completion Date :

Mar 9, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Chloroprocaine 3% All the eligible patients will be administrated by Chloroprocaine 3 % according to the randomization criteria.	Drug: 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. Other Names: Arm 1
Active Comparator: Tetracaine 0.5% All the eligible patients will be administrated by Tetracaine 0.5% according to the randomization criteria.	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. Other Names: Arm 2

Arm

Intervention/Treatment

Experimental: Chloroprocaine 3%

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

Drug: 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.

Other Names:

Arm 1

Active Comparator: Tetracaine 0.5%

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

Drug: Tetracaine 0.5%

Other Names:

Arm 2

Outcome Measures

Primary Outcome Measures

The proportion of subjects in each treatment group with a successful surface anesthesia. [Before IOL implantation surgery.]
Τhe primary endpoint is the proportion of subjects in each treatment group with a successful surface anesthesia, without any supplementation at the time point T4.

Secondary Outcome Measures

Ocular symptoms; [up to 102 days]
Ocular symptoms (pain, irritation/burning/stinging, photophobia, foreign body sensation) will be graded by the patients according to the following scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe.
Objective ocular signs [up to 102 days]
- Objective ocular signs (palpebral edema, chemosis, conjunctival hyperemia, conjunctival discharge, follico-papillary conjunctivitis, corneal staining punctuations, anterior chamber cells) 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.
Slit lamp examination [up to 102 days]
Modification of the basal status of the assesment
Endothelial cell counts [up to 102 days]
Modification of the basal status of the assesment
Corneal thickness [up to 102 days]
Modification of the basal status of the assesment
Best far corrected visual acuity [up to 102 days]
Modification of the basal status of the assesment
Fundoscopy [up to 102 days]
Modification of the basal status of the assesment
Intra-ocular pressure [up to 102 days]
Modification of the basal status of the assesment
AEs occurrence [up to 133 days]
Number of AE occuring
Surgeon satisfaction [day 1]
Evaluation of surgeon satisfaction. How do you consider the study product global tolerance?: (0) = Very satisfactory = Satisfactory = Unsatisfactory = Very unsatisfactory
Patient global satisfaction [day 1]
Patient global satisfaction at D1 based on a 5-question questionnaire read by a masked observer.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Policlinico S. Orsola-Malpighi - Dipartimento testa collo, U.O. Oftalmologia Ciardella	Bologna		Italy	40138
2	A.O. Mater Domini di Catanzaro - U.O. Oculistica	Catanzaro		Italy	88100
3	A.O.U. Careggi di Firenze - Dipartimento neuromuscoloscheletrico e organi di senso, reparto di oculistica	Firenze		Italy	50134
4	"IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano" - Dipartimento di chirurgia, U.O. Oculistica	Milano		Italy	20122
5	Gruppo Multimedica Ospedale San Giuseppe di Milano - Clinica oculistica	Milano		Italy	20123
6	Ospedale San Raffaele IRCCS - Clinica oculistica	Milano		Italy	20123
7	ASST Santi Paolo e Carlo - Presidio Ospedale San Paolo - Dipartimento testa collo, reparto di oculistica	Milano		Italy	20142
8	Fondazione IRCCS Policlinico S. Matteo - Dipartimento di scienze chirurgiche, U.O. Oculistica	Pavia		Italy	27100
9	A.O. di Perugia - Ospedale S. Maria della Misericordia di Perugia - Clinica oculistica	Perugia		Italy	06129
10	A.O.U. Pisana - Cisanello - D.A.I. Specialità chirurgiche, U.O. Oculistica	Pisa		Italy	56126
11	Policlinico Universitario Campus Bio-medico di Roma - U.O.C. Oftalmologia	Roma		Italy	00128
12	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	00133
13	Ospedale Oftalmico di Roma (ASL Roma 1) - Dipartimento di oculistica e rete oftalmologica	Roma		Italy	00136
14	IRCCS Fondazione G.B. Bietti di Roma - U.O.S. Segmento anteriore con annessi oculari	Roma		Italy	00198
15	A.O.U. Senese - Università degli Studi di Siena - Dipartimento della salute mentale e degli organi di senso, U.O.C. Oculistica	Siena		Italy	53100
16	Az. Sanitaria Universitaria Integrata di Udine - P.O. Universitario "Santa Maria della Misericordia" - Dipartimento di chirurgia specialistica, clinica oculistica	Udine		Italy	33100
17	Izak Vision Center s.r.o.	Banská Bystrica		Slovakia	974 01
18	FNsP F. D. Roosevelta Banská Bystrica II. Očná klinika SZU	Banská Bystrica		Slovakia	975 17
19	ROBIN LOOK spol. s r.o., Centrum mikrochirurgie oka	Bratislava		Slovakia	821 03
20	Vesely Očná Klinika, s.r.o.	Bratislava		Slovakia	821 08
21	3F s.r.o. Očná ambulancia a optika	Košice		Slovakia	040 11
22	UVEA KLINIKA, s.r.o.	Martin		Slovakia	036 01
23	VIDISSIMO s. r. o. Očná klinika	Trenčín		Slovakia	911 08
24	Fakultná nemocnica s poliklinikou Žilina Očné oddelenie	Žilina		Slovakia	012 07
25	Oftalvist Cio Jerez Clinic	Jerez de la Frontera	Cadiz	Spain	11408
26	Vissum alicante	Alicante		Spain	03016
27	Instituto Oftalmológico Integral Servicio de Oftalmología Admiravisión en Clínica Corachan	Barcelona		Spain	08017