Back to resultsEvaluation of Neovis® Total Multi Versus Systane® Balance on Ocular Dryness Associated With Meibomian Gland Dysfunction
Primary Purpose
Dry Eye, Meibomian Gland Dysfunction
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Neovis Total Multi
Systane Balance
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Investigational product
Comparator
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
Meibomian gland expression (performance)
Main change from baseline of meibomian gland expression score in the worse eye and contralateral eye
Meibomian gland expression (performance)
Main change from baseline of meibomian gland expression score in the worse eye and contralateral eye
Meibum quality (performance)
Main change from baseline of meibum quality score in the worse eye and contralateral eye
Meibum quality (performance)
Main change from baseline of meibum quality score in the worse eye and contralateral eye
Meiboscopy (performance)
Main change from baseline of the number of partially missing or dropout meibomian glands in the worse eye and contralateral eye
Meiboscopy (performance)
Main change from baseline of the number of partially missing or dropout meibomian glands in the worse eye and contralateral eye
Eyelid margin abnormalities (performance)
Main change from baseline of the eyelid margin abnormalities score in the worse eye and contralateral eye
Eyelid margin abnormalities (performance)
Main change from baseline of the eyelid margin abnormalities score in the worse eye and contralateral eye
OSDI (questionnaire) (performance)
Main change from baseline of OSDI (Ocular Surface Disease Index) in the worse eye and contralateral eye
OSDI (questionnaire) (performance)
Main change from baseline of OSDI (Ocular Surface Disease Index) in the worse eye and contralateral eye
Global performance by the investigator (performance)
Global performance assessment by the investigator using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Global performance by the investigator (performance)
Global performance assessment by the investigator using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Global performance by the patient (performance)
Global performance assessment by the patient using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Global performance by the patient (performance)
Global performance assessment by the patient using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Global tolerance by the investigator (safety)
Global tolerance assessment by the investigator using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Global tolerance by the investigator (safety)
Global tolerance assessment by the investigator using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Global tolerance by the patient (safety)
Global tolerance assessment by the patient using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Global tolerance by the patient (safety)
Global tolerance assessment by the patient using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Intensity of ocular symptoms upon instillation (safety)
Evaluation of intensity of ocular symptoms upon instillation on a scale from 0 (none) to 3 (severe)
Intensity of ocular symptoms upon instillation (safety)
Evaluation of intensity of ocular symptoms upon instillation on a scale from 0 (none) to 3 (severe)
Duration of ocular symptoms upon instillation (safety)
Evaluation of duration of ocular symptoms upon instillation in seconds/minutes/hours
Duration of ocular symptoms upon instillation (safety)
Evaluation of duration of ocular symptoms upon instillation in seconds/minutes/hours
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)
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)
Number of Adverse Events
Collection of ocular and systemic adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05191771
Brief Title
Evaluation of Neovis® Total Multi Versus Systane® Balance on Ocular Dryness Associated With Meibomian Gland Dysfunction
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2022 (Anticipated)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Horus Pharma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye, Meibomian Gland Dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Investigational product
Arm Type
Experimental
Arm Title
Comparator
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Neovis Total Multi
Intervention Description
1 drop in each eye, 4 times per day
Intervention Type
Device
Intervention Name(s)
Systane Balance
Intervention Description
1 drop in each eye, 4 times per day
Primary Outcome Measure Information:
Title
Tear-Film Break Up Time (TBUT)
Description
Evaluation of the non-inferiority of Neovis® Total Multi in comparison with Systane® Balance, in terms of TBUT improvement, on worse eye
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Tear-Film Break Up Time (TBUT) (performance)
Description
Main change from baseline of Tear-Film Break Up Time (TBUT) in the worse eye and contralateral eye
Time Frame
84 days
Title
Cornea and conjunctiva staining (Oxford score) (performance)
Description
Main change from baseline of cornea and conjunctiva staining (Oxford score) in the worse eye and contralateral eye
Time Frame
28 days
Title
Cornea and conjunctiva staining (Oxford score) (performance)
Description
Main change from baseline of cornea and conjunctiva staining (Oxford score) in the worse eye and contralateral eye
Time Frame
84 days
Title
Meibomian gland expression (performance)
Description
Main change from baseline of meibomian gland expression score in the worse eye and contralateral eye
Time Frame
28 days
Title
Meibomian gland expression (performance)
Description
Main change from baseline of meibomian gland expression score in the worse eye and contralateral eye
Time Frame
84 days
Title
Meibum quality (performance)
Description
Main change from baseline of meibum quality score in the worse eye and contralateral eye
Time Frame
28 days
Title
Meibum quality (performance)
Description
Main change from baseline of meibum quality score in the worse eye and contralateral eye
Time Frame
84 days
Title
Meiboscopy (performance)
Description
Main change from baseline of the number of partially missing or dropout meibomian glands in the worse eye and contralateral eye
Time Frame
28 days
Title
Meiboscopy (performance)
Description
Main change from baseline of the number of partially missing or dropout meibomian glands in the worse eye and contralateral eye
Time Frame
84 days
Title
Eyelid margin abnormalities (performance)
Description
Main change from baseline of the eyelid margin abnormalities score in the worse eye and contralateral eye
Time Frame
28 days
Title
Eyelid margin abnormalities (performance)
Description
Main change from baseline of the eyelid margin abnormalities score in the worse eye and contralateral eye
Time Frame
84 days
Title
OSDI (questionnaire) (performance)
Description
Main change from baseline of OSDI (Ocular Surface Disease Index) in the worse eye and contralateral eye
Time Frame
28 days
Title
OSDI (questionnaire) (performance)
Description
Main change from baseline of OSDI (Ocular Surface Disease Index) in the worse eye and contralateral eye
Time Frame
84 days
Title
Global performance by the investigator (performance)
Description
Global performance assessment by the investigator using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Time Frame
28 days
Title
Global performance by the investigator (performance)
Description
Global performance assessment by the investigator using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Time Frame
84 days
Title
Global performance by the patient (performance)
Description
Global performance assessment by the patient using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Time Frame
28 days
Title
Global performance by the patient (performance)
Description
Global performance assessment by the patient using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Time Frame
84 days
Title
Global tolerance by the investigator (safety)
Description
Global tolerance assessment by the investigator using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Time Frame
28 days
Title
Global tolerance by the investigator (safety)
Description
Global tolerance assessment by the investigator using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Time Frame
84 days
Title
Global tolerance by the patient (safety)
Description
Global tolerance assessment by the patient using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Time Frame
28 days
Title
Global tolerance by the patient (safety)
Description
Global tolerance assessment by the patient using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Time Frame
84 days
Title
Intensity of ocular symptoms upon instillation (safety)
Description
Evaluation of intensity of ocular symptoms upon instillation on a scale from 0 (none) to 3 (severe)
Time Frame
28 days
Title
Intensity of ocular symptoms upon instillation (safety)
Description
Evaluation of intensity of ocular symptoms upon instillation on a scale from 0 (none) to 3 (severe)
Time Frame
84 days
Title
Duration of ocular symptoms upon instillation (safety)
Description
Evaluation of duration of ocular symptoms upon instillation in seconds/minutes/hours
Time Frame
28 days
Title
Duration of ocular symptoms upon instillation (safety)
Description
Evaluation of duration of ocular symptoms upon instillation in seconds/minutes/hours
Time Frame
84 days
Title
Frequency of ocular symptoms upon instillation (safety)
Description
Evaluation of frequency of ocular symptoms upon instillation on a scale from 1 (rarely) to 4 (very often)
Time Frame
28 days
Title
Frequency of ocular symptoms upon instillation (safety)
Description
Evaluation of frequency of ocular symptoms upon instillation on a scale from 1 (rarely) to 4 (very often)
Time Frame
84 days
Title
Number of Adverse Events
Description
Collection of ocular and systemic adverse events
Time Frame
84 days
Other Pre-specified Outcome Measures:
Title
Non-Invasive Tear film Break-Up Time (NIBUT) (exploratory, optional)
Description
Main change from baseline of Non-Invasive Tear film Break-Up Time (NIBUT) in the worse eye and contralateral eye
Time Frame
28 days
Title
Non-Invasive Tear film Break-Up Time (NIBUT) (exploratory, optional)
Description
Main change from baseline of Non-Invasive Tear film Break-Up Time (NIBUT) in the worse eye and contralateral eye
Time Frame
84 days
Title
Lipid layer thickness (exploratory, optional)
Description
Main change from baseline of lipid layer thickness with interferometry methods in the worse eye and contralateral eye
Time Frame
28 days
Title
Lipid layer thickness (exploratory, optional)
Description
Main change from baseline of lipid layer thickness with interferometry methods in the worse eye and contralateral eye
Time Frame
84 days
Title
Functional visual acuity (exploratory, optional)
Description
Main change from baseline of functional visual acuity in the worse eye and contralateral eye
Time Frame
28 days
Title
Functional visual acuity (exploratory, optional)
Description
Main change from baseline of functional visual acuity in the worse eye and contralateral eye
Time Frame
84 days
Title
Super Oxyde Dismutase (SOD) dosage (exploratory, optional)
Description
Main change from baseline of SOD1 and SOD2 in the worse eye
Time Frame
84 days
Title
Goblet cells analysis (exploratory, optional)
Description
Main change from baseline of Goblet cells in the worse eye
Time Frame
84 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laure Chauchat
Phone
+33 (0)4 89 08 90 98
Email
laure.chauchat@horus-pharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hoffart Louis
Organizational Affiliation
Vision Sud
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Depending on any journal publication of the results
Learn more about this trial
Evaluation of Neovis® Total Multi Versus Systane® Balance on Ocular Dryness Associated With Meibomian Gland Dysfunction
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