Evaluation of Neovis® Total Multi Versus Systane® Balance on Ocular Dryness Associated With Meibomian Gland Dysfunction
3 janvier 2022 mis à jour par: Horus Pharma
Multicentric, Randomized, Comparative Clinical Study on the Evaluation of the Efficacy and Safety of Neovis® Total Multi Versus Systane® Balance on the Treatment of Ocular Dryness Associated With Meibomian Gland Dysfunction
This study is a multicentric, comparative, randomized, investigator-blinded, in parallel groups study to demonstrate the non-inferiority of Neovis® Total Multi in comparison with Systane® Balance, in terms of improvement of stability of Tear film in patients with eye dryness associated to meibomian gland dysfunction, after 28 days of treatment.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Anticipé)
120
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Laure Chauchat
- Numéro de téléphone: +33 (0)4 89 08 90 98
- E-mail: laure.chauchat@horus-pharma.com
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Presenting dry eye symptoms for at least 6 months.
- OSDI (Ocular Surface Disease Index) ≥ 18
At least one eye eligible with:
- sum of peripheral corneal and conjunctival staining ≥ 4 and ≤ 9 (Oxford 0-15 grading scheme) AND
- sum of 3 measurements of Tear film Break-Up Time (TBUT) ≤ 15s
- Meibomian Gland Dysfunction on at least one eye (same eye eligible) with a score of 1 or higher for meibum quality score (from 0: clear to 3: toothpaste/obstruction) and evidence of partial or whole missing Meibomian Glands.
- Ability and willingness to apply eyelid hygiene during the whole study, including wash-out period.
- Having given freely and expressly his/her informed consent.
- Able to comply with the study requirements, as defined in the present CIP, at the Investigator's appreciation.
- In France: subject being affiliated to a health social security system.
- Female subjects of childbearing potential should use a medically accepted contraceptive regimen since at least 12 weeks before the beginning of the study, during all the study and at least 1 month after the study end.
Exclusion Criteria:
- Pregnant or nursing woman or planning a pregnancy during the study.
- Subject deprived of freedom by administrative or legal decision.
- Subject in a social or health institution
- Subject who is under guardianship or who is not able to express his/her consent.
- Use of contact lenses in either eye during the study.
- Far best-corrected visual acuity ≤ 1/10.
Subject with severe ocular dryness with one of these conditions:
- Eyelid or blinking malfunction
- Corneal disorders not related to dry eye syndrome
- Ocular metaplasia
- Filamentous keratitis
- Corneal neovascularization
- History of ocular traumatism, ocular infection or ocular inflammation within the last 3 months.
- History of ocular allergy or ocular herpes within the last 12 months.
- Subjects who underwent ocular surgery, including laser surgery, in either eye within the last 6 months.
- Any troubles of the ocular surface not related to dry eye syndrome.
- Use of the following ocular treatments: isotretinoïd, cyclosporine, tacrolimus, sirolimus, pimecrolimus during the month preceding the inclusion.
- IOP > 21 mmHg
- Uncontrolled systemic disease
- Alcohol abuse
- Psychiatric disorders
- Cognitive impairment that could affect evaluation of preferences or inability to understand written patient information
- Participation in other clinical studies in the last month
- Hypersensitivity to one or more components of the study product
- Dry eye due to systemic disease, concomitant medication, malign conditions or idiopathic causes
- Punctual plugs during the past 3 months
- Use of lipid-containing eye drops during the past 3 months
- Use of other therapeutic ophthalmics during the past 3 months
- Earlier participation at this clinical trial or the patient being an investigator or a member of the personnel involved at this clinical trial
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Produit expérimental
|
1 drop in each eye, 4 times per day
|
|
Comparateur actif: Comparateur
|
1 drop in each eye, 4 times per day
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Tear-Film Break Up Time (TBUT)
Délai: 28 days
|
Evaluation of the non-inferiority of Neovis® Total Multi in comparison with Systane® Balance, in terms of TBUT improvement, on worse eye
|
28 days
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Temps de rupture du film lacrymal (TBUT) (performance)
Délai: 84 jours
|
Principal changement par rapport à la valeur initiale du temps de rupture du film lacrymal (TBUT) dans l'œil le plus malade et l'œil controlatéral
|
84 jours
|
|
Cornea and conjunctiva staining (Oxford score) (performance)
Délai: 28 days
|
Main change from baseline of cornea and conjunctiva staining (Oxford score) in the worse eye and contralateral eye
|
28 days
|
|
Coloration de la cornée et de la conjonctive (score d'Oxford) (performance)
Délai: 84 jours
|
Principal changement par rapport à la coloration initiale de la cornée et de la conjonctive (score d'Oxford) dans l'œil le plus mauvais et l'œil controlatéral
|
84 jours
|
|
Meibomian gland expression (performance)
Délai: 28 days
|
Main change from baseline of meibomian gland expression score in the worse eye and contralateral eye
|
28 days
|
|
Meibomian gland expression (performance)
Délai: 84 days
|
Main change from baseline of meibomian gland expression score in the worse eye and contralateral eye
|
84 days
|
|
Meibum quality (performance)
Délai: 28 days
|
Main change from baseline of meibum quality score in the worse eye and contralateral eye
|
28 days
|
|
Meibum quality (performance)
Délai: 84 days
|
Main change from baseline of meibum quality score in the worse eye and contralateral eye
|
84 days
|
|
Meiboscopy (performance)
Délai: 28 days
|
Main change from baseline of the number of partially missing or dropout meibomian glands in the worse eye and contralateral eye
|
28 days
|
|
Meiboscopy (performance)
Délai: 84 days
|
Main change from baseline of the number of partially missing or dropout meibomian glands in the worse eye and contralateral eye
|
84 days
|
|
Eyelid margin abnormalities (performance)
Délai: 28 days
|
Main change from baseline of the eyelid margin abnormalities score in the worse eye and contralateral eye
|
28 days
|
|
Eyelid margin abnormalities (performance)
Délai: 84 days
|
Main change from baseline of the eyelid margin abnormalities score in the worse eye and contralateral eye
|
84 days
|
|
OSDI (questionnaire) (performance)
Délai: 28 days
|
Main change from baseline of OSDI (Ocular Surface Disease Index) in the worse eye and contralateral eye
|
28 days
|
|
OSDI (questionnaire) (performance)
Délai: 84 days
|
Main change from baseline of OSDI (Ocular Surface Disease Index) in the worse eye and contralateral eye
|
84 days
|
|
Global performance by the investigator (performance)
Délai: 28 days
|
Global performance assessment by the investigator using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
|
28 days
|
|
Performance globale de l'enquêteur (performance)
Délai: 84 jours
|
Évaluation globale de la performance par l'investigateur sur une échelle de 4 points (Insatisfaisant, Peu satisfaisant, Satisfaisant, Très satisfaisant)
|
84 jours
|
|
Global performance by the patient (performance)
Délai: 28 days
|
Global performance assessment by the patient using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
|
28 days
|
|
Global performance by the patient (performance)
Délai: 84 days
|
Global performance assessment by the patient using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
|
84 days
|
|
Global tolerance by the investigator (safety)
Délai: 28 days
|
Global tolerance assessment by the investigator using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
|
28 days
|
|
Global tolerance by the investigator (safety)
Délai: 84 days
|
Global tolerance assessment by the investigator using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
|
84 days
|
|
Global tolerance by the patient (safety)
Délai: 28 days
|
Global tolerance assessment by the patient using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
|
28 days
|
|
Global tolerance by the patient (safety)
Délai: 84 days
|
Global tolerance assessment by the patient using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
|
84 days
|
|
Intensity of ocular symptoms upon instillation (safety)
Délai: 28 days
|
Evaluation of intensity of ocular symptoms upon instillation on a scale from 0 (none) to 3 (severe)
|
28 days
|
|
Intensity of ocular symptoms upon instillation (safety)
Délai: 84 days
|
Evaluation of intensity of ocular symptoms upon instillation on a scale from 0 (none) to 3 (severe)
|
84 days
|
|
Duration of ocular symptoms upon instillation (safety)
Délai: 28 days
|
Evaluation of duration of ocular symptoms upon instillation in seconds/minutes/hours
|
28 days
|
|
Duration of ocular symptoms upon instillation (safety)
Délai: 84 days
|
Evaluation of duration of ocular symptoms upon instillation in seconds/minutes/hours
|
84 days
|
|
Frequency of ocular symptoms upon instillation (safety)
Délai: 28 days
|
Evaluation of frequency of ocular symptoms upon instillation on a scale from 1 (rarely) to 4 (very often)
|
28 days
|
|
Frequency of ocular symptoms upon instillation (safety)
Délai: 84 days
|
Evaluation of frequency of ocular symptoms upon instillation on a scale from 1 (rarely) to 4 (very often)
|
84 days
|
|
Number of Adverse Events
Délai: 84 days
|
Collection of ocular and systemic adverse events
|
84 days
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Non-Invasive Tear film Break-Up Time (NIBUT) (exploratory, optional)
Délai: 28 days
|
Main change from baseline of Non-Invasive Tear film Break-Up Time (NIBUT) in the worse eye and contralateral eye
|
28 days
|
|
Non-Invasive Tear film Break-Up Time (NIBUT) (exploratory, optional)
Délai: 84 days
|
Main change from baseline of Non-Invasive Tear film Break-Up Time (NIBUT) in the worse eye and contralateral eye
|
84 days
|
|
Lipid layer thickness (exploratory, optional)
Délai: 28 days
|
Main change from baseline of lipid layer thickness with interferometry methods in the worse eye and contralateral eye
|
28 days
|
|
Lipid layer thickness (exploratory, optional)
Délai: 84 days
|
Main change from baseline of lipid layer thickness with interferometry methods in the worse eye and contralateral eye
|
84 days
|
|
Functional visual acuity (exploratory, optional)
Délai: 28 days
|
Main change from baseline of functional visual acuity in the worse eye and contralateral eye
|
28 days
|
|
Functional visual acuity (exploratory, optional)
Délai: 84 days
|
Main change from baseline of functional visual acuity in the worse eye and contralateral eye
|
84 days
|
|
Super Oxyde Dismutase (SOD) dosage (exploratory, optional)
Délai: 84 days
|
Main change from baseline of SOD1 and SOD2 in the worse eye
|
84 days
|
|
Goblet cells analysis (exploratory, optional)
Délai: 84 days
|
Main change from baseline of Goblet cells in the worse eye
|
84 days
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Hoffart Louis, Vision Sud
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Anticipé)
1 janvier 2022
Achèvement primaire (Anticipé)
1 octobre 2022
Achèvement de l'étude (Anticipé)
1 décembre 2022
Dates d'inscription aux études
Première soumission
10 décembre 2021
Première soumission répondant aux critères de contrôle qualité
3 janvier 2022
Première publication (Réel)
13 janvier 2022
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
13 janvier 2022
Dernière mise à jour soumise répondant aux critères de contrôle qualité
3 janvier 2022
Dernière vérification
1 janvier 2022
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 21E1007
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Indécis
Description du régime IPD
Depending on any journal publication of the results
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .