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

NCT ID: NCT05191771

Last Updated: 2022-01-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-31
• Study Completion Date: 2022-12-31

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.

Conditions

Dry Eye; Meibomian Gland Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Investigational product

Group Type: EXPERIMENTAL

Neovis Total Multi

Intervention Type: DEVICE

1 drop in each eye, 4 times per day

Comparator

Group Type: ACTIVE_COMPARATOR

Systane Balance

Intervention Type: DEVICE

1 drop in each eye, 4 times per day

Interventions

Neovis Total Multi

1 drop in each eye, 4 times per day

Intervention Type: DEVICE

Systane Balance

1 drop in each eye, 4 times per day

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Horus Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hoffart Louis

Role: PRINCIPAL_INVESTIGATOR

Vision Sud

Central Contacts

Laure Chauchat

Role: CONTACT

laure.chauchat@horus-pharma.com

+33 (0)4 89 08 90 98

Other Identifiers

21E1007

Identifier Type: -

Identifier Source: org_study_id