Efficacy and safety assessment of an injectable solution containing the three active substances in the same vial (tropicamide, phenylephrine for mydriaticc effect and lidocaine for anesthesia) used for cataract surgery

Efficacy and safety assessment of intracameral T2380 (Fixed combination of lidocaine, phenylephrine and tropicamide) for mydriasis and anaesthesia in phacoemulsification cataract surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-021188-34-PT

Enrollment

560

Registered

2011-04-20

Start date

2011-07-01

Completion date

Unknown

Last updated

2014-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The aim of this clinical study will be to develop a combination of active substances enabling to obtain at the same time a mydriasis and an anaesthesia during cataract surgery MedDRA version: 14.1 Level: PT Classification code 10011719 Term: Cycloplegia System Organ Class: 10015919 - Eye disorders MedDRA version: 14.1 Level: LLT Classification code 10002325 Term: Anesthesia local System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.1 Level: PT Classification code

Interventions

Product Name: Mydrane Product Code: T2380 Pharmaceutical Form: Solution for injection CAS Number: 73-78-9 Other descriptive name: LIDOCAINE HYDROCHLORIDED Concentration unit: % percent Concentration t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Signed and dated informed consent -Male or female aged from 40 to 88 years old -Scheduled to undergo unilateral cataract surgery -Pupil diameter = 7 mm at selection visit after dilatation Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 450 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

Exclusion criteria: Surgical conditions in the eye to be operated: - Combined surgery - Previous intraocular surgery Non-surgical conditions in the eye to be operated: - Iatrogenic or traumatic or congenital cataract. - Pupillary abnormalities (irregular,..) - Very dark iris - Iris synechiae - Eye movement disorder (Nystagmus,..) - Dacryocystitis and all others 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 - Pseudoexfoliation, exfoliative syndrome

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary efficacy variableThe primary efficacy variable is response based on the realisation of the capsulorhexis without use of any additive mydriatic treatment. A responder is defined as a patient for whom the capsulorhexis is performed without use of any additive mydriatic treatment.Additive treatments are for both groups any supplementary drug with a mydriatic action other than planned by the protocol, and/or the use of medical device for opening the pupil, between the first instillation of study product and the capsulorhexis.Co-primary efficacy variableThe co-primary efficacy variable is response based on the realisation of the capsulorhexis without use of any additive mydriatic treatment and the measurement of pupil size just before capsulorhexis (T3). A responder is defined as a patient for whom the capsulorhexis is performed without use of any additive mydriatic treatment and for whom the pupil size at T3 is greater than or equal to 5.5 mm.;Secondary Objective: Secondary efficacy variables -Pupil size measured at the time T4. -Pupil size measured at the times T1, T2, T3 and T5. -Assessment of patient's discomfort at T1 to T5. -Time necessary for obtaining sufficient mydriasis : -For T2380 group : Delay between the first injection and T3-For reference group : Delay between the first instillation of mydriatic and T3 -Questioning about the number of supplementary drops or injection necessary to maintain mydriasis -Questioning about the number of supplementary drops or injection necessary to maintain anaesthesia. -Delay between the first instillation (mydriatic for reference group, tetracaine for T2380 group) and the first incision. -Delay between T3 and cefuroxime injection -Total surgical time (first incision to cefuroxime injection) -Assessment of the surgeon statisfaction of each stage (2nd incision, capsulorhexis, phacoemulsification, cortex aspiration, IOL implantation). ;Primary end point(s): The primary efficacy variable is response base	—

Measure

Time frame

Main Objective: Primary efficacy variableThe primary efficacy variable is response based on the realisation of the capsulorhexis without use of any additive mydriatic treatment. A responder is defined as a patient for whom the capsulorhexis is performed without use of any additive mydriatic treatment.Additive treatments are for both groups any supplementary drug with a mydriatic action other than planned by the protocol, and/or the use of medical device for opening the pupil, between the first instillation of study product and the capsulorhexis.Co-primary efficacy variableThe co-primary efficacy variable is response based on the realisation of the capsulorhexis without use of any additive mydriatic treatment and the measurement of pupil size just before capsulorhexis (T3). A responder is defined as a patient for whom the capsulorhexis is performed without use of any additive mydriatic treatment and for whom the pupil size at T3 is greater than or equal to 5.5 mm.;Secondary Objective: Secondary efficacy variables -Pupil size measured at the time T4. -Pupil size measured at the times T1, T2, T3 and T5. -Assessment of patient's discomfort at T1 to T5. -Time necessary for obtaining sufficient mydriasis : -For T2380 group : Delay between the first injection and T3-For reference group : Delay between the first instillation of mydriatic and T3 -Questioning about the number of supplementary drops or injection necessary to maintain mydriasis -Questioning about the number of supplementary drops or injection necessary to maintain anaesthesia. -Delay between the first instillation (mydriatic for reference group, tetracaine for T2380 group) and the first incision. -Delay between T3 and cefuroxime injection -Total surgical time (first incision to cefuroxime injection) -Assessment of the surgeon statisfaction of each stage (2nd incision, capsulorhexis, phacoemulsification, cortex aspiration, IOL implantation). ;Primary end point(s): The primary efficacy variable is response base

—

Secondary

Measure	Time frame
Secondary end point(s): Pupil size measured Assessment of patient's discomfort Time necessary for obtaining sufficient mydriasis Questioning about the number of supplementary drops or injection necessary to maintain mydriasis Questioning about the number of supplementary drops or injection necessary to maintain anaesthesia. Delay between the first instillation (mydriatic for reference group, tetracaine for T2380 group) and the first incision. Delay between T3 and cefuroxime injection Total surgical time (first incision to cefuroxime injection) Assessment of the surgeon statisfaction of each stage (2nd incision, capsulorhexis, phacoemulsification, cortex aspiration, IOL implantation).;Timepoint(s) of evaluation of this end point: Secondary efficacy variable will be realsied the day of surgery on T1, T2, T3, T4 AND T5.	—

Measure

Time frame

Secondary end point(s): Pupil size measured Assessment of patient's discomfort Time necessary for obtaining sufficient mydriasis Questioning about the number of supplementary drops or injection necessary to maintain mydriasis Questioning about the number of supplementary drops or injection necessary to maintain anaesthesia. Delay between the first instillation (mydriatic for reference group, tetracaine for T2380 group) and the first incision. Delay between T3 and cefuroxime injection Total surgical time (first incision to cefuroxime injection) Assessment of the surgeon statisfaction of each stage (2nd incision, capsulorhexis, phacoemulsification, cortex aspiration, IOL implantation).;Timepoint(s) of evaluation of this end point: Secondary efficacy variable will be realsied the day of surgery on T1, T2, T3, T4 AND T5.

—

Countries

Austria, Belgium, Germany, Italy, Portugal, Spain, Sweden

Contacts

Public ContactClinical Trial Department

Laboratoires Théa

s.guyon@laboratoires-thea.fr0033473981430

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026