Clinical trial • Phase IV • Ophthalmology
Anhydrous lidocaine hydrochloride for Glaucoma
Phase IV trial of Anhydrous lidocaine hydrochloride for Glaucoma.
Overview
- Trial Therapeutic Area
- Ophthalmology
- Trial Disease
- Glaucoma
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 23-10-2023
- First CTIS Authorization Date
- 19-02-2024
Trial design
Ophtesic 20 mg/g (anhydrous lidocaine hydrochloride) eye gel (test) versus COLIROFTA ANESTÉSICO DOBLE (oxybuprocaine hydrochloride 4 mg/ml + tetracaine hydrochloride 1 mg/ml; listed as 0.4% oxybuprocaine / 0.1% tetracaine) eye drops (comparator). Route: ophthalmic. Dose schedules/frequency not specified in the record.-controlled Phase IV trial across 1 site in Spain.
- Comparator
- Ophtesic 20 mg/g (anhydrous lidocaine hydrochloride) eye gel (test) versus COLIROFTA ANESTÉSICO DOBLE (oxybuprocaine hydrochloride 4 mg/ml + tetracaine hydrochloride 1 mg/ml; listed as 0.4% oxybuprocaine / 0.1% tetracaine) eye drops (comparator). Route: ophthalmic. Dose schedules/frequency not specified in the record.
- Target Sample Size
- 60
Eligibility
Recruits 60 isVulnerablePopulationSelected: false. Participants must be over 18 years of age and have understood and signed the informed consent (no assent process described)..
- Pregnancy Exclusion
- Pregnant or lactating patients.
- Vulnerable Population
- isVulnerablePopulationSelected: false. Participants must be over 18 years of age and have understood and signed the informed consent (no assent process described).
Inclusion criteria
- {"criterion_text":"- Patients operated on glaucoma surgery with filter blister who require the needling procedure"}
- {"criterion_text":"- Patients over 18 years of age, who have understood and signed the informed consent."}
Exclusion criteria
- {"criterion_text":"- Pregnant or lactating patients."}
- {"criterion_text":"- Patients with cognitive impairment who do not understand the visual analogue scale."}
- {"criterion_text":"- Hearing loss that prevents the patient from collaborating"}
- {"criterion_text":"- Anxiety disorder that prevents patient's collaboration during the procedure"}
- {"criterion_text":"- Allergy to topical anesthetics"}
- {"criterion_text":"- Patients who require needling in the operating room"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Assessment of pain manifested by patients by numerical rating scale (NRS) from 0 to 10 /Average time spent on the procedure in both anesthetic treatment groups","definition_or_measurement_approach":"Pain assessed by numerical rating scale (NRS) from 0 to 10; procedure time measured as average time spent on the procedure in each anesthetic treatment group."}
Secondary endpoints
- {"endpoint_text":"- Percentage of patients requiring re-anaesthesia in both treatment groups","definition_or_measurement_approach":"Proportion/percentage of patients in each treatment group requiring re‑anesthesia."}
- {"endpoint_text":"- Surgeon comfort/degree of patient cooperation: numerical rating scale (NRS) from 0 to 10.","definition_or_measurement_approach":"Surgeon comfort/patient cooperation assessed using a numerical rating scale (NRS) from 0 to 10."}
- {"endpoint_text":"- Percentage of patients requiring oral analgesia","definition_or_measurement_approach":"Proportion/percentage of patients in each group who require oral analgesia post-procedure."}
- {"endpoint_text":"- Assessment of the visualization of the surgical field using a numerical scale from 0 to 5, with 5 being the best possible visualization","definition_or_measurement_approach":"Visualization of the surgical field assessed using a numerical scale from 0 to 5 (5 = best visualization)."}
Recruitment
- Planned Sample Size
- 60
- Recruitment Window Months
- 7
- Consent Approach
- Informed consent required: participants must be over 18 years of age and have understood and signed the informed consent. No assent process or languages specified.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 60
Spain
- Earliest CTIS Part Ii Submission Date
- 30-01-2024
- Latest Decision Or Authorization Date
- 19-02-2024
- Processing Time Days
- 20
- Number Of Sites
- 1
- Number Of Participants
- 60
Sites
- Site Name
- Hospital Universitario De Torrevieja
- Department Name
- Oftalmologia
- Principal Investigator Name
- Carolina Medina Martin
- Principal Investigator Email
- medinamartin.cmm@gmail.com
- Contact Person Name
- Carolina Medina Martin
- Contact Person Email
- medinamartin.cmm@gmail.com
- Number Of Participants
- 60
Sponsor
Primary sponsor
- Full Name
- Hospital Universitario De Torrevieja
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- Ophtesic 20 mg/g, gel oftálmico en envase unidosis
- Active Substance
- Anhydrous lidocaine hydrochloride
- Modality
- Small molecule
- Routes Of Administration
- Ophthalmic
- Route
- Ophthalmic
- Authorisation Status
- Authorised
- Maximum Dose
- 1 g
- Investigational Product Name
- COLIROFTA ANESTÉSICO DOBLE 1 MG/ML + 4 MG/ML COLIRIO EN SOLUCIÓN
- Active Substance
- Oxybuprocaine hydrochloride; Tetracaine hydrochloride
- Modality
- Small molecule
- Routes Of Administration
- Ophthalmic
- Route
- Ophthalmic
- Authorisation Status
- Authorised
- Maximum Dose
- 0.1 ml
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