Overview
Sponsor-declared trial summary
glaucoma
To compare the anaesthetic efficacy of 2% lidocaine gel with 0.1% hydrochloride tetracaine eye drops / 0.4% oxybuprocaine hydrochloride in the in-office needling procedure in glaucoma surgery patients. To determine the mean procedure time in both anaesthetic treatment arms.
Key facts
- Sponsor
- Hospital Universitario De Torrevieja
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Eye Diseases [C11]
- Trial duration
- 9 Oct 2024 → ongoing
- Decision date (initial)
- 2024-02-19
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Horus Pharma
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy
To compare the anaesthetic efficacy of 2% lidocaine gel with 0.1% hydrochloride tetracaine eye drops / 0.4% oxybuprocaine hydrochloride in the in-office needling procedure in glaucoma surgery patients.
To determine the mean procedure time in both anaesthetic treatment arms.
Secondary objectives 3
- To assess the comfort of the surgeon in the ambulatory needling technique with both anesthetic modalities
- To assess the visualization obtained from the surgical field with both anesthetic procedures
- Quantify the need for re-anesthesia
Conditions and MedDRA coding
glaucoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10018304 | Glaucoma | 100000004853 |
Regulatory references
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-505802-40-00 | Clinical study of the anesthetic efficacy of 2% lidocaine gel versus tetracaine/oxybuprocaine anesthetic eye drops in patients operated on for glaucoma and undergoing needing techniques in outpatient surgery | Hospital Universitario De Torrevieja |
| 2023-505802-40-01 | Clinical study of the anesthetic efficacy of 2% lidocaine gel versus tetracaine/oxybuprocaine anesthetic eye drops in patients operated on for glaucoma and undergoing needing techniques in outpatient surgery | Hospital Universitario De Torrevieja |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Patients operated on glaucoma surgery with filter blister who require the needling procedure
- Patients over 18 years of age, who have understood and signed the informed consent.
Exclusion criteria 6
- Pregnant or lactating patients.
- Patients with cognitive impairment who do not understand the visual analogue scale.
- Hearing loss that prevents the patient from collaborating
- Anxiety disorder that prevents patient's collaboration during the procedure
- Allergy to topical anesthetics
- Patients who require needling in the operating room
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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
Secondary endpoints 4
- Percentage of patients requiring re-anaesthesia in both treatment groups
- Surgeon comfort/degree of patient cooperation: numerical rating scale (NRS) from 0 to 10.
- Percentage of patients requiring oral analgesia
- Assessment of the visualization of the surgical field using a numerical scale from 0 to 5, with 5 being the best possible visualization
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Ophtesic 20 mg/g, gel oftálmico en envase unidosis
PRD8007356 · Product
- Active substance
- Anhydrous Lidocaine Hydrochloride
- Pharmaceutical form
- EYE GEL
- Route of administration
- OPHTHALMIC USE
- Max daily dose
- 1 g gram(s)
- Max total dose
- 1 g gram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- S01HA07 — LIDOCAINE
- Marketing authorisation
- 84450
- MA holder
- LABORATOIRES DOLIAGE DEVELOPPEMENT
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
Colirofta Anestésico Doble 1 Mg/Ml + 4 Mg/Ml Colirio En Solución
PRD7478890 · Product
- Active substance
- Oxybuprocaine Hydrochloride
- Pharmaceutical form
- EYE DROPS, SOLUTION
- Route of administration
- OPHTHALMIC USE
- Max daily dose
- 0.1 ml millilitre(s)
- Max total dose
- 0.1 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- S01HA30 — COMBINATIONS
- Marketing authorisation
- 27.090
- MA holder
- ALCON HEALTHCARE S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Hospital Universitario De Torrevieja
- Sponsor organisation
- Hospital Universitario De Torrevieja
- Address
- Carretera Cv 95 S/n
- City
- Alicante
- Postcode
- 03186
- Country
- Spain
Scientific contact point
- Organisation
- Hospital Universitario De Torrevieja
- Contact name
- Carolina Medina Martin
Public contact point
- Organisation
- Hospital Universitario De Torrevieja
- Contact name
- Carolina Medina Martin
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruiting | 60 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2024-10-09 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-23 | Spain | Acceptable 2024-02-16
|
2024-02-19 |