E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The primary aim of this study is to evaluate mydriasis obtained with T2380 (Fixed combination of lidocaïne, phenylephrine and tropicamide) in patients with small pupils |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Body processes [G] - Ocular Physiological Phenomena [G14] |
MedDRA Classification |
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 |
The primary aim of this study is to evaluate mydriasis obtained with T2380 on patients with small pupils.
The primary efficacy variable is the ability of the surgeon to perform a circumlinear capsulorhexis with a stable pupil size of at least 5 mm without using any other method to dilate the pupil. |
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E.2.2 | Secondary objectives of the trial |
The secondary efficacy variables are:
• Pupil size measured at the times T1, T2, T3, T4 and T5
• Total surgical time (first incision to IOL implantation)
• Assessment of patient’s discomfort at T1 to T5
• Assessment of the surgeon satisfaction of each stage (2nd incision, capsulorhexis, phacoemulsification, cortex aspiration, IOL implantation).
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Signed and dated informed consent
• Male or female aged over 40 years old of age
• Scheduled to undergo cataract surgery by phacoemulsification (Under topical anesthesia and through clear corneal incision with placement in the bag of an foldable IOL)
• Dilatation of the pupil from 5mm ≤ Pupil diameter < 7mm after the following dilatation protocol at the selection visit: 3 combined instillations of TROPICAMIDE 0.5%® + NEOSYNEPHRINE 10%® at 10 minutes intervals
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E.4 | Principal exclusion criteria |
Ophthalmic 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.
- Deformed pupil and /or iris synechiae
- Very dark iris impeding slit lamp or video measures of pupil dilatation
- Eye movement disorder (Nystagmus,..)
- Dacryocystitis and all others pathologies of tears drainage system
- History of Inflammatory ocular disease (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
• Ophthalmic conditions in the contra lateral eye:
- Best corrected visual acuity < 1/10
- Patient already included in the study for phakoexeresis
- History of ophthalmic surgical complication
Other exclusion criteria are defined in this protocol (Systemic/non ophthalmic exclusion criteria, Specific exclusion criteria for women, Exclusion criteria related to general conditions, Exclusion criteria related to concomitant medications).
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy variable is the ability of the surgeon to perform a circumlinear capsulorhexis with a stable pupil size of at least 5 mm without using any other method to dilate the pupil.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
In order to realise the measurement of pupil size at specific times, surgery will be divided into 5 time periods according to the scheme mentioned in the protocol.
Nota
Pupil size measurement:
The exact pupil size during surgery will be obtained following the formula:
Pupil size = photo pupil size X corrective factor*
(*) corrective factor = real HVID / photo HVID
with HVID = Horizontal Visible Iris Diameter (i.e. horizontal white to white). Real HVID will be measured using IOL master during the selection visit. Photo HVID will be measured on each photo taken at 5 stages during the surgery.
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E.5.2 | Secondary end point(s) |
Principal secondary end point of surgery will be T1, T2, T4 and T5
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The pupil size will be measured on photos taken from surgery video recordings at the 5 times of surgery:
• Just before the first incision (T1)
• Just before OVD injection (T2)
• Just before capsulorhexis (T3)
• Just before IOL injection (T4)
• Just after IOL implantation (T5)
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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 | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 12 |
E.8.9.2 | In all countries concerned by the trial days | 0 |