E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Eye Diseases [C11] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10063797 |
E.1.2 | Term | Cataract operation |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
Assess the clinical efficacy and safety of 3% chloroprocaine gel compared to those of tetracaine 0.5% eye drop. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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)
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E.4 | Principal 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). |
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E.5 End points |
E.5.1 | Primary end point(s) |
Τhe proportion of subjects in each treatment group with a successful surface anesthesia, without any supplementation at the time point T4.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
T4 = just before Intra Ocular Lens implantation |
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E.5.2 | 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). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Several timepoints (during and after surgery) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 28 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last Patient Last Visit (LPLV) |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 7 |