Clinical trial NCT05191771: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Dry Eye
Meibomian Gland Dysfunction
Lead sponsor: Horus Pharma
Sponsor class: INDUSTRY
First posted: 2022-01-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Tear-Film Break Up Time (TBUT)
timeFrame: 28 days
Secondary outcomes:
measure: Tear-Film Break Up Time (TBUT) (performance)
timeFrame: 84 days
measure: Cornea and conjunctiva staining (Oxford score) (performance)
timeFrame: 28 days
measure: Cornea and conjunctiva staining (Oxford score) (performance)
timeFrame: 84 days
measure: Meibomian gland expression (performance)
timeFrame: 28 days
measure: Meibomian gland expression (performance)
timeFrame: 84 days
measure: Meibum quality (performance)
timeFrame: 28 days
measure: Meibum quality (performance)
timeFrame: 84 days
measure: Meiboscopy (performance)
timeFrame: 28 days
measure: Meiboscopy (performance)
timeFrame: 84 days
measure: Eyelid margin abnormalities (performance)
timeFrame: 28 days
measure: Eyelid margin abnormalities (performance)
timeFrame: 84 days
measure: OSDI (questionnaire) (performance)
timeFrame: 28 days
measure: OSDI (questionnaire) (performance)
timeFrame: 84 days
measure: Global performance by the investigator (performance)
timeFrame: 28 days
measure: Global performance by the investigator (performance)
timeFrame: 84 days
measure: Global performance by the patient (performance)
timeFrame: 28 days
measure: Global performance by the patient (performance)
timeFrame: 84 days
measure: Global tolerance by the investigator (safety)
timeFrame: 28 days
measure: Global tolerance by the investigator (safety)
timeFrame: 84 days
measure: Global tolerance by the patient (safety)
timeFrame: 28 days
measure: Global tolerance by the patient (safety)
timeFrame: 84 days
measure: Intensity of ocular symptoms upon instillation (safety)
timeFrame: 28 days
measure: Intensity of ocular symptoms upon instillation (safety)
timeFrame: 84 days
measure: Duration of ocular symptoms upon instillation (safety)
timeFrame: 28 days
measure: Duration of ocular symptoms upon instillation (safety)
timeFrame: 84 days
measure: Frequency of ocular symptoms upon instillation (safety)
timeFrame: 28 days
measure: Frequency of ocular symptoms upon instillation (safety)
timeFrame: 84 days
measure: Number of Adverse Events
timeFrame: 84 days
Other outcomes:
measure: Non-Invasive Tear film Break-Up Time (NIBUT) (exploratory, optional)
timeFrame: 28 days
measure: Non-Invasive Tear film Break-Up Time (NIBUT) (exploratory, optional)
timeFrame: 84 days
measure: Lipid layer thickness (exploratory, optional)
timeFrame: 28 days
measure: Lipid layer thickness (exploratory, optional)
timeFrame: 84 days
measure: Functional visual acuity (exploratory, optional)
timeFrame: 28 days
measure: Functional visual acuity (exploratory, optional)
timeFrame: 84 days
measure: Super Oxyde Dismutase (SOD) dosage (exploratory, optional)
timeFrame: 84 days
measure: Goblet cells analysis (exploratory, optional)
timeFrame: 84 days
Locations:
Study officials:
affiliation: Vision Sud
name: Hoffart Louis
role: PRINCIPAL_INVESTIGATOR
References: