E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with blepharitis |
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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 aim of this study is to demonstrate the efficacy of T1225 eye drops versus placebo eye drops on the global ocular discomfort ( (VAS) in patient with blepharitis after 3 monthly treatment periods of 7 days (1 drop twice daily the first day, following by one drop once daily for 6 days). |
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E.2.2 | Secondary objectives of the trial |
The secondary clinical efficacy objectives are as follow: •Global (subjective and objective) VAS = [Discomfort VAS + [(redness + swelling + MGD+ )VAS / 3] ] / 2 •To compare the efficacy of T1225 eye drops versus placebo with respect of the assessment of the patient’s symptomatology evaluation (VAS) after 7 days, 28 days and 57 days of study period, the ocular symptoms suggestive of blephatitis, the objective ocular signs (slit lamp examination, corneal stained punctuations, BUT values and the global efficacy assessment by the investigator. •To compare the ocular tolerance of T1225 eye drops versus placebo with respect of the assessment of the global local tolerance assessment by the investigator and by the patient.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Diagnosis of moderate to severe chronic blepharitis (posterior and/or anterior) in at least one eligible eye defined by: -a severity score ≥2 for either redness or swelling (or both) of the eyelid margin AND -a severity score ≥2 for either eyelid secretions or plugging of the MG (or both) AND -a severity score ≥2 for at least 2 symptoms among the following : irritation, burning, itching, tearing, crusting eyelashes, eyelid sticking, light sensitivity, increased frequency of blinking. AND -a Global Ocular Discomfort by VAS > 35 mm
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E.4 | Principal exclusion criteria |
-Monophtalmia -Eyelid dysfunction: Eyelid malposition, eyelash malposition, ectropion, entropion, malocclusion.Blepharospasm,Facial paralysis. -Severe dry eye syndrome defined by at least one of the following criteria : Total cornea fluorescein staining score ≥ 4 (NEI scale, using a five-zone system with 0-3 grades in each zone) and with at least one area of grade 2 in one zone in the same eye. - Ocular metaplasia. - Filamentous keratitis -Schirmer test < 5 mm. -Best far corrected visual acuity ≤ 1/10.
-History of Inflammatory ocular disease such as : uveitis, recidivant herpetic keratitis, atopic keratoconjunctivitis, Steven-Johnson Syndrome, Scare pemphigoid, -History WITHIN THE LAST 3 MONTHS before the inclusion visit of : Traumatism, Infection.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary objective is to evaluate the efficacy of the treatment by the change from baseline (Day 0) to Day 63 ± 3 Days of the global ocular discomfort (Visual Analogue Scale). |
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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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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 | 7 |
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 | Information not present in EudraCT |
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 visit of the last patient included |
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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 | 6 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |