cataract surgery MedDRA version: 20.0 Level: PT Classification code 10063797 Term: Cataract operation System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Product Name: Chloroprocaine 3%
Pharmaceutical Form: Eye gel
INN or Proposed INN: CHLOROPROCAINE
CAS Number: 133-16-4
Concentration unit: % (W/V) percent weight/volume
Concentration type: equal
Concen
Sponsors
Sintetica S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be enrolled in this study, subjects must fulfil all these 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: Patients fulfilling at the selection visit ONE OR MORE of the following exclusion criteria will not be enrolled in the study: 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.) Other criteria are defined in the study protocol (Systemic/non ophthalmic exclusion criteria, Specific exclusion criteria for women, Exclusion criteria related to general conditions, Exclusion criteria related to previous and concomitant medications / non-product therapies).
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 at T4 (just before Intra Ocular Lens implantation) Successful surface anesthesia & Supplementation are defined in the study protocol. ;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): ?he proportion of subjects in each treatment group with a successful surface anesthesia, without any supplementation at the time point T4. ;Timepoint(s) of evaluation of this end point: T4 = just before Intra Ocular Lens implantation | — |
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 | — |
Countries
Italy, Slovakia, Spain
Contacts
Public ContactClinical Operations
Iris Pharma
Outcome results
None listed