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

Multicentric, Randomized, Comparative Clinical Study on the Evaluation of the Efficacy and Safety of Neovis® Total Multi Versus Systane® Balance on the Treatment of Ocular Dryness Associated With Meibomian Gland Dysfunction

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dry Eye; Meibomian Gland Dysfunction
• Intervention / Treatment: Device: Neovis Total Multi; Device: Systane Balance

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laure Chauchat; Phone Number: +33 (0)4 89 08 90 98; Email: laure.chauchat@horus-pharma.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigational product	Device: Neovis Total Multi; 1 drop in each eye, 4 times per day
Active Comparator: Comparator	Device: Systane Balance; 1 drop in each eye, 4 times per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Other Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Horus Pharma
• Investigators: Principal Investigator: Hoffart Louis, Vision Sud

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2022
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: December 10, 2021
• First Submitted That Met QC Criteria: January 3, 2022
• First Posted (Actual): January 13, 2022

Study Record Updates

• Last Update Posted (Actual): January 13, 2022
• Last Update Submitted That Met QC Criteria: January 3, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Eyelid Diseases; Meibomian Gland Dysfunction
• Other Study ID Numbers: 21E1007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Depending on any journal publication of the results

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No