The aim of the development was to develop a combination of active substances enabling to obtain at the same time a mydriasis and an anaesthesia during cataract surgery. MedDRA version: 9.1 Level: LLT Classification code 10002325 Term: Anesthesia local MedDRA version: 9.1 Level: PT Classification code 10011719 Term: Cycloplegia MedDRA version: 9.1 Level: LLT Classification code 10028521 Term: Mydriasis
Conditions
Interventions
Product Name: Mydricaine
Product Code: T2380
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Lidocaine
CAS Number: 73-78-9
Concentration unit: % percent
Concentration type: equal
Conc
Sponsors
Laboratoires Théa
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1.1] Signed and dated informed consent [1.2] Male or female aged from 18 to 85 years old [1.3] Senile or pre-senile cataract [1.4] Scheduled to undergo cataract surgery (clear corneal self sealing incisions- phacoemulsification – foldable intra-ocular lens surgery with injector) [1.5] Endothelial cell count > 2000 cell/mm2 [1.6] Pupil diameter = 7 mm Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Ophthalmic non-inclusion criteria (in either eye) [2.1] [2.1.1] Surgical conditions in the eye to be operated: [2.1.1.1] Combined surgery [2.1.1.2] Previous intraocular surgery [2.1.2] Non-surgical conditions in the eye to be operated: [2.1.2.1] Pupillary abnormalities (irregular,..) [2.1.2.2] Very dark iris [2.1.2.3] Iris synechiae [2.1.2.4] Eye movement disorder (Nystagmus,..) [2.1.2.5] Dacryocystitis and all others pathologies of tears drainage system [2.1.2.6] History of Inflammatory ocular disease (Iritis, uveitis, herpetic keratitis) [2.1.2.7] Corneal, epithelial, stromal or endothelial, residual or evolutionary disease (including corneal ulceration and superficial punctuate keratitis) [2.1.2.8] History of ocular traumatism, infection or inflammation within the last 3 months [2.1.2.9] Pseudoexfoliation, exfoliative syndrom [2.1.3] Ophthalmic conditions in the contra lateral eye: [2.1.3.1] Best corrected visual acuity < 1/10 [2.1.3.2] Patient already included in the study for phakoexeresis [2.1.3.3] History of ophthalmic surgical complication (cystoid macular oedema,..) [2.1.4] Ophthalmic conditions in either eye: [2.1.4.1]Presence of glaucoma and/or ocular hypertension history Systemic/non ophthalmic non-inclusion criteria [2.2] [2.2.1] General history: [2.2.1.1] Diabetes mellitus [2.2.1.2] Surdity [2.2.1.3] Excessive anxiety [2.2.1.4] Any other medical or surgical history, disorder or disease such as acute or chronic severe organic disease: hepatic, endocrine neoplasic, haematological diseases, severe psychiatric illness, relevant cardiovascular abnormalities (such as unstable angina, uncontrolled hypertension: systolic blood pressure over 200 mmHG, diastolic blood pressure over 100 mmHg) etc... and/or any complicating factor or structural abnormality judged by the investigator to be incompatible with the study [2.2.2] Allergic history: [2.2.2.1] Known hypersensitivity to one of the components of the study medications or to test products [2.2.2.2] Allergic rhinitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This pilot clinical study aims to evaluate efficacy and safety of two volumes (V= 150 µl and V= 200 µl) of T2380, an injectable solution combining two mydriatic agents tropicamide and phenylephrine at the concentrations of 0.02% and 0.31% respectively, and one anaesthetic agent lidocaine 1%, after intracameral injection during cataract surgery versus 2 groups of topical reference therapy, one of them with an intracamerular injection of lidocaine. The primary efficacy variable combines the measurement of pupil size and the assessment of patient discomfort of the operated eye on a 6 points ordinal scale. The treatment will be judged to be effective if at the time just before the foldable intra-ocular lens (IOL) injection (time T4), pupil size will be at least 6 mm and patient discomfort assessed as 0 (=no pain or pressure) or 1 (=mild pressure, no discomfort).;Secondary Objective: 1)Clinical efficacy: -Effectiveness of the treatment (i.e pupil size = 6 mm and patient discomfort =1 at T3 -Pupil dilation of the operated eye at each of the 5 recording times. -Patient discomfort at each of the 5 recording times. -Time to obtain sufficient mydriasis. -Number of supplementary drops or supplementary injection necessary for maintaining mydriasis and for maintaining anaesthesia. -Total surgical time. -Assessment of surgical comfort by the surgeon of each stage of the surgical procedure 2)Ocular and systemic safety -Ocular symptoms -Objective ocular signs -Endothelial cells count -Corneal thickness -BCVA -Funduscopy -Retinal thickness -Intra-Ocular Pressure -blood pressure and heart rate -Adverse events ;Primary end point(s): Primary efficacy variable will combine at Day 0 criteria of pupil dilation = 6 mm and patient discomfort = 1 just before foldable IOL injection. | — |
Countries
Belgium, France, Portugal, Spain
Outcome results
None listed