CataractPhase 3NCT04685538
Chloroprocaine 3% Gel Eye Drop as Topical Anestheticsin Phacoemulsification.
A Phase 3 study testing Chloroprocaine 3% and Tetracaine 0.5% in people with Cataract, run by Sintetica SA at 27 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Chloroprocaine 3% and Tetracaine 0.5%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 338 participants
- Where
- 27 sitesin 3 countries
- Study dates
- 9 Sep 2020to 9 Mar 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 32Show fewer
- 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
Trial locations and contacts
27 sites in 3 countries.
27 sites in 3 countries
Italy16 sites
Policlinico S. Orsola-Malpighi - Dipartimento testa collo, U.O. Oftalmologia Ciardella
Bologna, 40138
A.O. Mater Domini di Catanzaro - U.O. Oculistica
Catanzaro, 88100
A.O.U. Careggi di Firenze - Dipartimento neuromuscoloscheletrico e organi di senso, reparto di oculistica
Florence, 50134
"IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano" - Dipartimento di chirurgia, U.O. Oculistica
Milan, 20122
Gruppo Multimedica Ospedale San Giuseppe di Milano - Clinica oculistica
Milan, 20123
Ospedale San Raffaele IRCCS - Clinica oculistica
Milan, 20123
ASST Santi Paolo e Carlo - Presidio Ospedale San Paolo - Dipartimento testa collo, reparto di oculistica
Milan, 20142
Fondazione IRCCS Policlinico S. Matteo - Dipartimento di scienze chirurgiche, U.O. Oculistica
Pavia, 27100
A.O. di Perugia - Ospedale S. Maria della Misericordia di Perugia - Clinica oculistica
Perugia, 06129
A.O.U. Pisana - Cisanello - D.A.I. Specialità chirurgiche, U.O. Oculistica
Pisa, 56126
Policlinico Universitario Campus Bio-medico di Roma - U.O.C. Oftalmologia
Roma, 00128
Fondazione PTV Policlinico Tor Vergata - Dipartimento benessere della salute mentale e neurologica, dentale e degli organi di senso, U.O.S.D. Oculistica
Roma, 00133
Ospedale Oftalmico di Roma (ASL Roma 1) - Dipartimento di oculistica e rete oftalmologica
Roma, 00136
IRCCS Fondazione G.B. Bietti di Roma - U.O.S. Segmento anteriore con annessi oculari
Roma, 00198
A.O.U. Senese - Università degli Studi di Siena - Dipartimento della salute mentale e degli organi di senso, U.O.C. Oculistica
Siena, 53100
Az. Sanitaria Universitaria Integrata di Udine - P.O. Universitario "Santa Maria della Misericordia" - Dipartimento di chirurgia specialistica, clinica oculistica
Udine, 33100
Slovakia8 sites
Izak Vision Center s.r.o.
Banská Bystrica, 974 01
FNsP F. D. Roosevelta Banská Bystrica II. Očná klinika SZU
Banská Bystrica, 975 17
ROBIN LOOK spol. s r.o., Centrum mikrochirurgie oka
Bratislava, 821 03
Vesely Očná Klinika, s.r.o.
Bratislava, 821 08
3F s.r.o. Očná ambulancia a optika
Košice, 040 11
UVEA KLINIKA, s.r.o.
Martin, 036 01
VIDISSIMO s. r. o. Očná klinika
Trenčín, 911 08
Fakultná nemocnica s poliklinikou Žilina Očné oddelenie
Žilina, 012 07
Spain3 sites
Vissum alicante
Alicante, 03016
Instituto Oftalmológico Integral Servicio de Oftalmología Admiravisión en Clínica Corachan
Barcelona, 08017
Oftalvist Cio Jerez Clinic
Jerez de la Frontera, Cadiz, 11408
About this study
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.
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.
Read the 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
- Being tested
- Chloroprocaine 3%, Tetracaine 0.5%
- Keywords
- Cataract, Eye, Chloroprocaine
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chloroprocaine 3%Drug
Also called Arm 1
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%Drug
Also called Arm 2
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.
| Study group | Role | What they receive |
|---|---|---|
| Chloroprocaine 3% | Experimental | All the eligible patients will be administrated by Chloroprocaine 3 % according to the randomization criteria. Receives: Drug: Chloroprocaine 3% |
| Tetracaine 0.5% | Active comparator | All the eligible patients will be administrated by Tetracaine 0.5% according to the randomization criteria. Receives: Drug: Tetracaine 0.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants in Each Treatment Group With a Successful Surface Anesthesia
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)
Measured: Before Intra Ocular Lens (IOL) implantation surgery.
Secondary outcomes (10)
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
Measured: Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days
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
Measured: Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days
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).
Measured: Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days
Endothelial Cell Counts
Modification of the basal status of the Endothelial cell counts evaluated with the specular microscopy
Measured: Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days
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
Measured: Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days
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.
Measured: Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days
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.
Measured: Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days
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).
Measured: Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days
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.
Measured: day 1 - visit2 (Inclusion visit/Surgery)
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.
Measured: day 1 - visit2 (Inclusion visit/Surgery) after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start9 Sep 2020
- Primary completion1 Mar 2021
- Study completion9 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 338 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sintetica SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jorge Alio, MD, Principal investigator, Vissum Alicante, Calle del Cabañal 1, 03016 Alicante, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04685538
- Sponsor's protocol ID
- CHL.3/01-2019/M
- Status last verified
- Apr 2021
- First submitted
- 15 Dec 2020
- Last updated
- 18 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38489057
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04685538
- Acronym / sponsor ID
- CHL.3/01-2019/M
- Conditions
- Cataract
- Keywords
- Cataract, Eye, Chloroprocaine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 338 participants (actual)
- Lead sponsor
- Sintetica SAIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 9 Mar 2021 (actual)
- First posted
- 28 Dec 2020 (actual)
- Results
- Posted 27 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chloroprocaine 3% | Experimental | Drug: Chloroprocaine 3%All the eligible patients will be administrated by Chloroprocaine 3 % according to the randomization criteria. |
| Tetracaine 0.5% | Active comparator | Drug: Tetracaine 0.5%All the eligible patients will be administrated by Tetracaine 0.5% according to the randomization criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (32 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chloroprocaine 3%Also: Arm 1Administration: 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. | Drug | Chloroprocaine 3% |
| Tetracaine 0.5%Also: Arm 2Administration: 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. | Drug | Tetracaine 0.5% |
Primary outcome
Number of Participants in Each Treatment Group With a Successful Surface Anesthesia
Time frame: 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)
10 secondary outcomes
Changes in Ocular Symptoms
Time frame: Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days
Objective Ocular Signs
Time frame: Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days
Fluoresceine
Time frame: Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days
Endothelial Cell Counts
Time frame: Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days
Corneal Thickness
Time frame: Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days
Best Far Corrected Visual Acuity
Time frame: Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days
Number of Participants With Abnormalities of the Retina, Macula, or Optic Nerve by Fundoscopy
Time frame: Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days
Intra-ocular Pressure
Time frame: Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days
Surgeon Satisfaction
Time frame: day 1 - visit2 (Inclusion visit/Surgery)
Patient Global Satisfaction
Time frame: day 1 - visit2 (Inclusion visit/Surgery) after the treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38489057Figus 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorge Alio, MD principal investigator
Vissum Alicante, Calle del Cabañal 1, 03016 Alicante, Spain
27 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Chloroprocaine 3% and Tetracaine 0.5% in people with Cataract, run by Sintetica SA at 27 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Italy, Slovakia, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants in Each Treatment Group With a Successful Surface Anesthesia (time frame: Before Intra Ocular Lens (IOL) implantation surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04685538, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023.