Evaluation of Neovis® Total Multi Versus Systane® Balance on Ocular Dryness Associated With Meibomian Gland Dysfunction

Horus Pharma

Status

Unknown

Conditions

Dry Eye

Meibomian Gland Dysfunction

Treatments

Device: Systane Balance

Device: Neovis Total Multi

Study type

Interventional

Funder types

Industry

Identifiers

NCT05191771

21E1007

Details and patient eligibility

About

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.

Enrollment

120 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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