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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05191771
Recruitment Status : Not yet recruiting
First Posted : January 13, 2022
Last Update Posted : January 13, 2022
Sponsor:
Information provided by (Responsible Party):
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.

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

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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

Resource links provided by the National Library of Medicine


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




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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05191771


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

Sponsors and Collaborators
Horus Pharma
Investigators
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Principal Investigator: Hoffart Louis Vision Sud
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Responsible Party: Horus Pharma
ClinicalTrials.gov Identifier: NCT05191771    
Other Study ID Numbers: 21E1007
First Posted: January 13, 2022    Key Record Dates
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Meibomian Gland Dysfunction
Eye Diseases
Eyelid Diseases