Dry Eye, Meibomian Gland Dysfunction
Conditions
Brief summary
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.
Interventions
DEVICENeovis Total Multi
1 drop in each eye, 4 times per day
DEVICESystane Balance
1 drop in each eye, 4 times per day
Sponsors
Horus Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tear-Film Break Up Time (TBUT) | 28 days | Evaluation of the non-inferiority of Neovis® Total Multi in comparison with Systane® Balance, in terms of TBUT improvement, on worse eye |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Eyelid margin abnormalities (performance) | 28 days | Main change from baseline of the eyelid margin abnormalities score in the worse eye and contralateral eye |
| Global tolerance by the patient (safety) | 28 days | Global tolerance assessment by the patient using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory) |
| Intensity of ocular symptoms upon instillation (safety) | 28 days | Evaluation of intensity of ocular symptoms upon instillation on a scale from 0 (none) to 3 (severe) |
| Duration of ocular symptoms upon instillation (safety) | 28 days | Evaluation of duration of ocular symptoms upon instillation in seconds/minutes/hours |
| Frequency of ocular symptoms upon instillation (safety) | 28 days | Evaluation of frequency of ocular symptoms upon instillation on a scale from 1 (rarely) to 4 (very often) |
| Number of Adverse Events | 84 days | Collection of ocular and systemic adverse events |
| Tear-Film Break Up Time (TBUT) (performance) | 84 days | Main change from baseline of Tear-Film Break Up Time (TBUT) in the worse eye and contralateral eye |
| Cornea and conjunctiva staining (Oxford score) (performance) | 28 days | Main change from baseline of cornea and conjunctiva staining (Oxford score) in the worse eye and contralateral eye |
| Meibomian gland expression (performance) | 28 days | Main change from baseline of meibomian gland expression score in the worse eye and contralateral eye |
| Meibum quality (performance) | 28 days | Main change from baseline of meibum quality score in the worse eye and contralateral eye |
| Meiboscopy (performance) | 28 days | Main change from baseline of the number of partially missing or dropout meibomian glands in the worse eye and contralateral eye |
| OSDI (questionnaire) (performance) | 28 days | Main change from baseline of OSDI (Ocular Surface Disease Index) in the worse eye and contralateral eye |
| Global performance by the investigator (performance) | 28 days | Global performance assessment by the investigator using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory) |
| Global performance by the patient (performance) | 28 days | Global performance assessment by the patient using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory) |
| Global tolerance by the investigator (safety) | 28 days | Global tolerance assessment by the investigator using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Functional visual acuity (exploratory, optional) | 28 days | Main change from baseline of functional visual acuity in the worse eye and contralateral eye |
| Super Oxyde Dismutase (SOD) dosage (exploratory, optional) | 84 days | Main change from baseline of SOD1 and SOD2 in the worse eye |
| Goblet cells analysis (exploratory, optional) | 84 days | Main change from baseline of Goblet cells in the worse eye |
| Lipid layer thickness (exploratory, optional) | 28 days | Main change from baseline of lipid layer thickness with interferometry methods in the worse eye and contralateral eye |
| Non-Invasive Tear film Break-Up Time (NIBUT) (exploratory, optional) | 28 days | Main change from baseline of Non-Invasive Tear film Break-Up Time (NIBUT) in the worse eye and contralateral eye |
Contacts
Primary ContactLaure Chauchat
Outcome results
None listed