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

• ClinicalTrials.gov Identifier: NCT05191771
• Recruitment Status: Not yet recruiting
• First Posted: January 13, 2022
• Last Update Posted: January 13, 2022
• Sponsor: Horus Pharma
• Information provided by (Responsible Party): Horus Pharma

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Dry Eye; Meibomian Gland Dysfunction	Device: Neovis Total Multi; Device: Systane Balance	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Estimated Study Start Date: January 2022
• Estimated Primary Completion Date: October 2022
• Estimated Study Completion Date: December 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Tear-Film Break Up Time (TBUT) [ Time Frame: 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 :

1. Tear-Film Break Up Time (TBUT) (performance) [ Time Frame: 84 days ]
   Main change from baseline of Tear-Film Break Up Time (TBUT) in the worse eye and contralateral eye
2. Cornea and conjunctiva staining (Oxford score) (performance) [ Time Frame: 28 days ]
   Main change from baseline of cornea and conjunctiva staining (Oxford score) in the worse eye and contralateral eye
3. Cornea and conjunctiva staining (Oxford score) (performance) [ Time Frame: 84 days ]
   Main change from baseline of cornea and conjunctiva staining (Oxford score) in the worse eye and contralateral eye
4. Meibomian gland expression (performance) [ Time Frame: 28 days ]
   Main change from baseline of meibomian gland expression score in the worse eye and contralateral eye
5. Meibomian gland expression (performance) [ Time Frame: 84 days ]
   Main change from baseline of meibomian gland expression score in the worse eye and contralateral eye
6. Meibum quality (performance) [ Time Frame: 28 days ]
   Main change from baseline of meibum quality score in the worse eye and contralateral eye
7. Meibum quality (performance) [ Time Frame: 84 days ]
   Main change from baseline of meibum quality score in the worse eye and contralateral eye
8. Meiboscopy (performance) [ Time Frame: 28 days ]
   Main change from baseline of the number of partially missing or dropout meibomian glands in the worse eye and contralateral eye
9. Meiboscopy (performance) [ Time Frame: 84 days ]
   Main change from baseline of the number of partially missing or dropout meibomian glands in the worse eye and contralateral eye
10. Eyelid margin abnormalities (performance) [ Time Frame: 28 days ]
    Main change from baseline of the eyelid margin abnormalities score in the worse eye and contralateral eye
11. Eyelid margin abnormalities (performance) [ Time Frame: 84 days ]
    Main change from baseline of the eyelid margin abnormalities score in the worse eye and contralateral eye
12. OSDI (questionnaire) (performance) [ Time Frame: 28 days ]
    Main change from baseline of OSDI (Ocular Surface Disease Index) in the worse eye and contralateral eye
13. OSDI (questionnaire) (performance) [ Time Frame: 84 days ]
    Main change from baseline of OSDI (Ocular Surface Disease Index) in the worse eye and contralateral eye
14. Global performance by the investigator (performance) [ Time Frame: 28 days ]
    Global performance assessment by the investigator using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
15. Global performance by the investigator (performance) [ Time Frame: 84 days ]
    Global performance assessment by the investigator using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
16. Global performance by the patient (performance) [ Time Frame: 28 days ]
    Global performance assessment by the patient using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
17. Global performance by the patient (performance) [ Time Frame: 84 days ]
    Global performance assessment by the patient using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
18. Global tolerance by the investigator (safety) [ Time Frame: 28 days ]
    Global tolerance assessment by the investigator using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
19. Global tolerance by the investigator (safety) [ Time Frame: 84 days ]
    Global tolerance assessment by the investigator using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
20. Global tolerance by the patient (safety) [ Time Frame: 28 days ]
    Global tolerance assessment by the patient using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
21. Global tolerance by the patient (safety) [ Time Frame: 84 days ]
    Global tolerance assessment by the patient using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
22. Intensity of ocular symptoms upon instillation (safety) [ Time Frame: 28 days ]
    Evaluation of intensity of ocular symptoms upon instillation on a scale from 0 (none) to 3 (severe)
23. Intensity of ocular symptoms upon instillation (safety) [ Time Frame: 84 days ]
    Evaluation of intensity of ocular symptoms upon instillation on a scale from 0 (none) to 3 (severe)
24. Duration of ocular symptoms upon instillation (safety) [ Time Frame: 28 days ]
    Evaluation of duration of ocular symptoms upon instillation in seconds/minutes/hours
25. Duration of ocular symptoms upon instillation (safety) [ Time Frame: 84 days ]
    Evaluation of duration of ocular symptoms upon instillation in seconds/minutes/hours
26. Frequency of ocular symptoms upon instillation (safety) [ Time Frame: 28 days ]
    Evaluation of frequency of ocular symptoms upon instillation on a scale from 1 (rarely) to 4 (very often)
27. Frequency of ocular symptoms upon instillation (safety) [ Time Frame: 84 days ]
    Evaluation of frequency of ocular symptoms upon instillation on a scale from 1 (rarely) to 4 (very often)
28. Number of Adverse Events [ Time Frame: 84 days ]
    Collection of ocular and systemic adverse events

Other Outcome Measures:

1. Non-Invasive Tear film Break-Up Time (NIBUT) (exploratory, optional) [ Time Frame: 28 days ]
   Main change from baseline of Non-Invasive Tear film Break-Up Time (NIBUT) in the worse eye and contralateral eye
2. Non-Invasive Tear film Break-Up Time (NIBUT) (exploratory, optional) [ Time Frame: 84 days ]
   Main change from baseline of Non-Invasive Tear film Break-Up Time (NIBUT) in the worse eye and contralateral eye
3. Lipid layer thickness (exploratory, optional) [ Time Frame: 28 days ]
   Main change from baseline of lipid layer thickness with interferometry methods in the worse eye and contralateral eye
4. Lipid layer thickness (exploratory, optional) [ Time Frame: 84 days ]
   Main change from baseline of lipid layer thickness with interferometry methods in the worse eye and contralateral eye
5. Functional visual acuity (exploratory, optional) [ Time Frame: 28 days ]
   Main change from baseline of functional visual acuity in the worse eye and contralateral eye
6. Functional visual acuity (exploratory, optional) [ Time Frame: 84 days ]
   Main change from baseline of functional visual acuity in the worse eye and contralateral eye
7. Super Oxyde Dismutase (SOD) dosage (exploratory, optional) [ Time Frame: 84 days ]
   Main change from baseline of SOD1 and SOD2 in the worse eye
8. Goblet cells analysis (exploratory, optional) [ Time Frame: 84 days ]
   Main change from baseline of Goblet cells in the worse eye

Eligibility Criteria

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

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

Contacts and Locations

Contacts

Contact: Laure Chauchat; +33 (0)4 89 08 90 98; laure.chauchat@horus-pharma.com

Sponsors and Collaborators

Horus Pharma

Investigators

• Principal Investigator: Hoffart Louis; Vision Sud

More Information

• Responsible Party: Horus Pharma
• ClinicalTrials.gov Identifier: NCT05191771
• Other Study ID Numbers: 21E1007
• First Posted: January 13, 2022
• Last Update Posted: January 13, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: Depending on any journal publication of the results

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Meibomian Gland Dysfunction; Eye Diseases; Eyelid Diseases