Patients undergoing unilateral phacoemulsification MedDRA version: 21.1 Level: LLT Classification code 10059285 Term: Phacoemulsification System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Minims Tetracaine Hydrochloride 0.5% w/v Eye Drops, Solution
Product Name: Tetracaina Cloridrato 0.5%
Product Code: [PL 03468/0082 (AIC UK)]
Pharmaceutical Form: Eye drops, solution
Curre
Sponsors
SINTETICA S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed and dated informed consent 2. Male or female aged > = 18 years 3. Senile or pre-senile cataract 4. Scheduled to undergo cataract surgery in a single eye at a time (clear corneal self-sealing incisions - phacoemulsification – foldable intra-ocular lens surgery with injector) 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 228 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 114
Exclusion criteria
Exclusion criteria: Ophthalmic exclusion criteria - Surgical conditions in the eye to be operated: 1. Combined surgery 2. Previous intraocular surgery 3. Previous corneal refractive surgeries less than 6 months before screening - Non-surgical conditions in the eye to be operated: 4. Non Senile or non pre-senile cataract (e.g.: traumatic, pathological or congenital cataract) 5. Pupillary abnormalities (irregular, etc.) 6. Iris synechiae 7. Eye movement disorder (nystagmus, etc.) 8. Dacryocystitis and all other pathologies of tears drainage system 9. History of Inflammatory ocular disease (Iritis, uveitis, herpetic keratitis) 10. Corneal, epithelial, stromal or endothelial, residual or evolutionary disease (including corneal ulceration and superficial punctuate keratitis) 11. History of ocular traumatism, infection or inflammation within the last 3 months 12. Pseudo-exfoliation, exfoliative syndrome 13. Prior intravitreal injections within 7 days of the surgery 14. IOP over 25mmHg under treatment - Ophthalmic conditions in the contra-lateral eye: 15. Best corrected visual acuity < 1/10 16. Patient already included in the study for phakoexeresis 17. History of ophthalmic surgical complication (cystoid macular oedema, etc.) - Systemic/non ophthalmicexclusioncriteria --General history: 18. Diabetesmellitus 19. Surdity 20. Pakinsondisease 21. Excessive anxiety 22. 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. --Allergic history: 23. Known hypersensitivity to sulfonamides products or any of the components of the study medications or to test products Specific exclusion criteria for women 24. Pregnancy (positive pregnancy test), lactation 25. 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 26. Women not hysterectomized, not menopaused nor surgically sterilized. - Exclusion criteria related to general conditions 27. Inability of patient and/or relatives to understand the study procedures and thus inability to give informed consent 28. Non-compliant patient and/or relatives (e.g. not willing to attend the follow-up visits, way of life interfering with compliance) 29. Participation in anotherclinicalstudy 30. Already included once in this study 31. Ward of court 32. Patient not covered by the Social Security
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Equivalence evaluation of Test versus Reference products in terms of proportion of subjects with a successful surface anesthesia for cataract surgery, without any supplementation (see definitions below) at T4 (just before Intra Ocular Lens implantation) Successful surface anesthesia: The patient assessment of ocular discomfort during surgery must be 0 (=No pain or discomfort) or 1 (=Occasional pressure sensation, less than 5 separated times during procedure) without any supplementation at T4. Supplementation: Intra-operative analgesia, including additional LA drops administration, after the beginning of the surgery.;Secondary Objective: Assess the clinical efficacy and safety of 3% chloroprocaine gel compared to those of tetracaine 0.5% eye drop.;Primary end point(s): The proportion of subjects in each treatment group with a successful surface anesthesia, without any supplementation at the time point T4. A successful surface anesthesia is equal to 1 and is defined as ocular discomfort equal to 0 (=no pain or pressure) or 1 (=occasional pressure sensation, less than 5 separated times during procedure). It is equal to 0 otherwise (e.g. ocular discomfort > 1).;Timepoint(s) of evaluation of this end point: Just before intra ocular lens implantation (V2) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy end-points during surgery: - Successful surface anesthesia at T1, T2 and T3 based on patient questioning: Patient’s operated eye discomfort. - Time to obtain sufficient anesthesia (use of forceps). - Total time of anesthesia - Blinking reflex dropping a water drop at the end of the surgery - Number of supplemental drops necessary for obtaining and/or maintaining anesthesia - Supplementary treatments (general anesthesia or intra-operative systemic analgesia) necessary for obtaining and/or maintaining anesthesia - Total surgical time - Assessment of surgical comfort by the surgeon of each stage of the surgical procedure. - Assessment of the global efficacy by the surgeon for anesthesia. Safety end-points: - Ocular symptoms (pain, irritation/burning/stinging, photophobia, foreign body sensation) will be graded by the patients according to the following scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe. - Objective ocular signs (palpebral edema, chemosis, conjunctival hyperemia, conjunctival discharge, follico-papillary conjunctivitis, corneal staining punctuations, anterior chamber cells) 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. Modification of the basal status of the following assessments: - Slit lamp examination and fluorescein test - Endothelial cell counts (specular microscopy) - Corneal thickness (pachymetry) - Best far corrected visual acuity - Fundoscopy - Intra-ocular pressure - Vital signs (blood pressure and heart rate) - AEs occurrence - Surgeon satisfaction: “How do you consider the study product global tolerance” will be graded according to the following scale: 0 = very satisfactory, 1 = satisfactory, 2 = not very satisfactory, 3 = unsatisfactory. - Patient global satisfaction at Visit 3/D2 (5-scale points questionaire read by a masked observer).;Timepoint(s) of evaluation of this end p | — |
Countries
Italy, Slovakia, Spain
Contacts
Public ContactClinical Operations
Link Neuroscience and Health Care srl - L.N.Age srl
Outcome results
None listed