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

Not Applicable

• Conditions: Dry Eye; Meibomian Gland Dysfunction
• Interventions: Device: Neovis Total Multi; Device: Systane Balance

• Registration Number: NCT05191771
• Lead Sponsor: Horus Pharma

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-10
• Status Verified: 2022-01
• Study Start: 2022-01
• Study First Submitted QC: 2022-01-03
• Last Update Submitted: 2022-01-03
• Study First Posted: 2022-01-13
• Last Update Posted: 2022-01-13
• Primary Completion: 2022-10
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Investigational product	Neovis Total Multi	-
Comparator	Systane Balance	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Eyelid margin abnormalities (performance)	84 days	Main change from baseline of the eyelid margin abnormalities score in the worse eye and contralateral eye
OSDI (questionnaire) (performance)	84 days	Main change from baseline of OSDI (Ocular Surface Disease Index) in the worse eye and contralateral eye
Global performance by the patient (performance)	84 days	Global performance assessment by the patient using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Meibomian gland expression (performance)	84 days	Main change from baseline of meibomian gland expression score in the worse eye and contralateral eye
Meibum quality (performance)	84 days	Main change from baseline of meibum quality score in the worse eye and contralateral eye
Meiboscopy (performance)	84 days	Main change from baseline of the number of partially missing or dropout meibomian glands in the worse eye and contralateral eye
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)	84 days	Main change from baseline of cornea and conjunctiva staining (Oxford score) in the worse eye and contralateral eye
Global tolerance by the patient (safety)	84 days	Global tolerance assessment by the patient using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Number of Adverse Events	84 days	Collection of ocular and systemic adverse events
Global performance by the investigator (performance)	84 days	Global performance assessment by the investigator using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Global tolerance by the investigator (safety)	84 days	Global tolerance assessment by the investigator using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Intensity of ocular symptoms upon instillation (safety)	84 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)	84 days	Evaluation of duration of ocular symptoms upon instillation in seconds/minutes/hours
Frequency of ocular symptoms upon instillation (safety)	84 days	Evaluation of frequency of ocular symptoms upon instillation on a scale from 1 (rarely) to 4 (very often)