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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational product | Experimental |
| |
| Comparator | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neovis Total Multi | Device | 1 drop in each eye, 4 times per day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Tear-Film Break Up Time (TBUT) | Evaluation of the non-inferiority of Neovis® Total Multi in comparison with Systane® Balance, in terms of TBUT improvement, on worse eye | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Tear-Film Break Up Time (TBUT) (performance) | Main change from baseline of Tear-Film Break Up Time (TBUT) in the worse eye and contralateral eye | 84 days |
| Cornea and conjunctiva staining (Oxford score) (performance) |
| Measure | Description | Time Frame |
|---|---|---|
| Non-Invasive Tear film Break-Up Time (NIBUT) (exploratory, optional) | 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) |
Inclusion Criteria:
Presenting dry eye symptoms for at least 6 months.
OSDI (Ocular Surface Disease Index) ≥ 18
At least one eye eligible with:
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:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laure Chauchat | Contact | +33 (0)4 89 08 90 98 | laure.chauchat@horus-pharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Hoffart Louis | Vision Sud | Principal Investigator |
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Depending on any journal publication of the results
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D000080343 | Meibomian Gland Dysfunction |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D005141 | Eyelid Diseases |
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| Systane Balance |
| Device |
1 drop in each eye, 4 times per day |
|
Main change from baseline of cornea and conjunctiva staining (Oxford score) in the worse eye and contralateral eye
| 28 days |
| Cornea and conjunctiva staining (Oxford score) (performance) | Main change from baseline of cornea and conjunctiva staining (Oxford score) in the worse eye and contralateral eye | 84 days |
| Meibomian gland expression (performance) | Main change from baseline of meibomian gland expression score in the worse eye and contralateral eye | 28 days |
| Meibomian gland expression (performance) | Main change from baseline of meibomian gland expression score in the worse eye and contralateral eye | 84 days |
| Meibum quality (performance) | Main change from baseline of meibum quality score in the worse eye and contralateral eye | 28 days |
| Meibum quality (performance) | Main change from baseline of meibum quality score in the worse eye and contralateral eye | 84 days |
| Meiboscopy (performance) | 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) | 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) | Main change from baseline of the eyelid margin abnormalities score in the worse eye and contralateral eye | 28 days |
| Eyelid margin abnormalities (performance) | Main change from baseline of the eyelid margin abnormalities score in the worse eye and contralateral eye | 84 days |
| OSDI (questionnaire) (performance) | Main change from baseline of OSDI (Ocular Surface Disease Index) in the worse eye and contralateral eye | 28 days |
| OSDI (questionnaire) (performance) | 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) | Global performance assessment by the investigator using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory) | 28 days |
| Global performance by the investigator (performance) | Global performance assessment by the investigator using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory) | 84 days |
| Global performance by the patient (performance) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | Evaluation of duration of ocular symptoms upon instillation in seconds/minutes/hours | 28 days |
| Duration of ocular symptoms upon instillation (safety) | Evaluation of duration of ocular symptoms upon instillation in seconds/minutes/hours | 84 days |
| Frequency of ocular symptoms upon instillation (safety) | 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) | Evaluation of frequency of ocular symptoms upon instillation on a scale from 1 (rarely) to 4 (very often) | 84 days |
| Number of Adverse Events | Collection of ocular and systemic adverse events | 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) | 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) | 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) | Main change from baseline of functional visual acuity in the worse eye and contralateral eye | 28 days |
| Functional visual acuity (exploratory, optional) | Main change from baseline of functional visual acuity in the worse eye and contralateral eye | 84 days |
| Super Oxyde Dismutase (SOD) dosage (exploratory, optional) | Main change from baseline of SOD1 and SOD2 in the worse eye | 84 days |
| Goblet cells analysis (exploratory, optional) | Main change from baseline of Goblet cells in the worse eye | 84 days |