Chloroprocaine 3% Gel Eye Drop as Topical Anestheticsin Phacoemulsification.
- Registration Number
- NCT04685538
- Lead Sponsor
- Sintetica SA
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 338
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tetracaine 0.5% Tetracaine 0.5% All the eligible patients will be administrated by Tetracaine 0.5% according to the randomization criteria. Chloroprocaine 3% Chloroprocaine 3% All the eligible patients will be administrated by Chloroprocaine 3 % according to the randomization criteria.
- Primary Outcome Measures
Name Time Method Number of Participants in Each Treatment Group With a Successful Surface Anesthesia Before Intra Ocular Lens (IOL) implantation surgery. 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
Name Time Method Corneal Thickness Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days Modification of the basal status of the assesment (Corneal thickness). Measurement of the central corneal thickness was to be performed with a pachymeter
Number of Participants With Abnormalities of the Retina, Macula, or Optic Nerve by Fundoscopy Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days Modification of the basal status of the assesment. Dilated fundus examination on retina, macula, optic nerve.
Changes in Ocular Symptoms Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days 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 Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days - 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
Best Far Corrected Visual Acuity Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days 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.
Surgeon Satisfaction day 1 - visit2 (Inclusion visit/Surgery) 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.
Fluoresceine Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days 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 Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days Modification of the basal status of the Endothelial cell counts evaluated with the specular microscopy
Patient Global Satisfaction day 1 - visit2 (Inclusion visit/Surgery) after the treatment 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.Intra-ocular Pressure Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days Modification of the basal status of the assesment. Intraocular pressure (in mmHg) was assessed according to site current practice (air puff or applanation tonometer).
Trial Locations
- Locations (27)
Policlinico S. Orsola-Malpighi - Dipartimento testa collo, U.O. Oftalmologia Ciardella
🇮🇹Bologna, 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
Gruppo Multimedica Ospedale San Giuseppe di Milano - Clinica oculistica
🇮🇹Milano, Italy
ASST Santi Paolo e Carlo - Presidio Ospedale San Paolo - Dipartimento testa collo, reparto di oculistica
🇮🇹Milano, Italy
Fondazione IRCCS Policlinico S. Matteo - Dipartimento di scienze chirurgiche, U.O. Oculistica
🇮🇹Pavia, 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
Vesely Očná Klinika, s.r.o.
🇸🇰Bratislava, Slovakia
ROBIN LOOK spol. s r.o., Centrum mikrochirurgie oka
🇸🇰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
Instituto Oftalmológico Integral Servicio de Oftalmología Admiravisión en Clínica Corachan
🇪🇸Barcelona, Spain
Oftalvist Cio Jerez Clinic
🇪🇸Jerez de la Frontera, Cadiz, Spain
Vissum alicante
🇪🇸Alicante, Spain
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
Izak Vision Center s.r.o.
🇸🇰Banská Bystrica, Slovakia
FNsP F. D. Roosevelta Banská Bystrica II. Očná klinika SZU
🇸🇰Banská Bystrica, Slovakia
A.O. Mater Domini di Catanzaro - U.O. Oculistica
🇮🇹Catanzaro, Italy
Ospedale San Raffaele IRCCS - Clinica oculistica
🇮🇹Milano, Italy
A.O. di Perugia - Ospedale S. Maria della Misericordia di Perugia - Clinica oculistica
🇮🇹Perugia, Italy
Az. Sanitaria Universitaria Integrata di Udine - P.O. Universitario "Santa Maria della Misericordia" - Dipartimento di chirurgia specialistica, clinica oculistica
🇮🇹Udine, Italy
Fakultná nemocnica s poliklinikou Žilina Očné oddelenie
🇸🇰Žilina, Slovakia