Chloroprocaine 3% Gel Eye Drop as Topical Anestheticsin Phacoemulsification.

Cataract Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04685538
• Other study ID #: CHL.3/01-2019/M
• Status: Completed
• Phase: Phase 3
• Start date: September 9, 2020
• Est. completion date: March 9, 2021

Study information

• Verified date: April 2021
• Source: Sintetica SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 338
• Est. completion date: March 9, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	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	Firenze
Italy	"IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano" - Dipartimento di chirurgia, U.O. Oculistica	Milano
Italy	ASST Santi Paolo e Carlo - Presidio Ospedale San Paolo - Dipartimento testa collo, reparto di oculistica	Milano
Italy	Gruppo Multimedica Ospedale San Giuseppe di Milano - Clinica oculistica	Milano
Italy	Ospedale San Raffaele IRCCS - Clinica oculistica	Milano
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	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	IRCCS Fondazione G.B. Bietti di Roma - U.O.S. Segmento anteriore con annessi oculari	Roma
Italy	Ospedale Oftalmico di Roma (ASL Roma 1) - Dipartimento di oculistica e rete oftalmologica	Roma
Italy	Policlinico Universitario Campus Bio-medico di Roma - U.O.C. Oftalmologia	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
Slovakia	Fakultná nemocnica s poliklinikou Žilina Ocné oddelenie	Žilina
Slovakia	FNsP F. D. Roosevelta Banská Bystrica II. Ocná klinika SZU	Banská Bystrica
Slovakia	Izak Vision Center s.r.o.	Banská Bystrica
Slovakia	ROBIN LOOK spol. s r.o., Centrum mikrochirurgie oka	Bratislava
Slovakia	Vesely Ocná Klinika, s.r.o.	Bratislava
Slovakia	3F s.r.o. Ocná ambulancia a optika	Košice
Slovakia	UVEA KLINIKA, s.r.o.	Martin
Slovakia	VIDISSIMO s. r. o. Ocná klinika	Trencín
Spain	Vissum alicante	Alicante
Spain	Instituto Oftalmológico Integral Servicio de Oftalmología Admiravisión en Clínica Corachan	Barcelona
Spain	Oftalvist Cio Jerez Clinic	Jerez de la Frontera	Cadiz

Sponsors (1)

Lead Sponsor	Collaborator
Sintetica SA

Countries where clinical trial is conducted

Italy,  Slovakia,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants in Each Treatment Group With a Successful Surface Anesthesia	?he 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	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	Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days
Secondary	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	Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days
Secondary	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).	Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days
Secondary	Endothelial Cell Counts	Modification of the basal status of the Endothelial cell counts evaluated with the specular microscopy	Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days
Secondary	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	Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days
Secondary	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.	Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days
Secondary	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.	Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days
Secondary	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).	Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days
Secondary	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.	day 1 - visit2 (Inclusion visit/Surgery)
Secondary	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.	day 1 - visit2 (Inclusion visit/Surgery) after the treatment