Dry EyeNCT05191771
Evaluation of Neovis® Total Multi Versus Systane® Balance on Ocular Dryness Associated With Meibomian Gland Dysfunction
A study testing Neovis Total Multi and Systane Balance in people with Dry Eye and Meibomian Gland Dysfunction, run by Horus Pharma.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye, Meibomian Gland Dysfunction
- What is being tested?
- Neovis Total Multi and Systane Balance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jan 2022to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
- Conditions
- Dry Eye, Meibomian Gland Dysfunction
- Being tested
- Neovis Total Multi, Systane Balance
- Medical subject headings
- Dry Eye Syndromes, Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neovis Total MultiDevice
1 drop in each eye, 4 times per day
Systane BalanceDevice
1 drop in each eye, 4 times per day
| Study group | Role | What they receive |
|---|---|---|
| Investigational product | Experimental | Not described Receives: Device: Neovis Total Multi |
| Comparator | Active comparator | Not described Receives: Device: Systane Balance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 28 days
Secondary outcomes (28)
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
Measured: 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
Measured: 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
Measured: 84 days
Meibomian gland expression (performance)
Main change from baseline of meibomian gland expression score in the worse eye and contralateral eye
Measured: 28 days
Meibomian gland expression (performance)
Main change from baseline of meibomian gland expression score in the worse eye and contralateral eye
Measured: 84 days
Meibum quality (performance)
Main change from baseline of meibum quality score in the worse eye and contralateral eye
Measured: 28 days
Meibum quality (performance)
Main change from baseline of meibum quality score in the worse eye and contralateral eye
Measured: 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
Measured: 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
Measured: 84 days
Eyelid margin abnormalities (performance)
Main change from baseline of the eyelid margin abnormalities score in the worse eye and contralateral eye
Measured: 28 days
Eyelid margin abnormalities (performance)
Main change from baseline of the eyelid margin abnormalities score in the worse eye and contralateral eye
Measured: 84 days
OSDI (questionnaire) (performance)
Main change from baseline of OSDI (Ocular Surface Disease Index) in the worse eye and contralateral eye
Measured: 28 days
OSDI (questionnaire) (performance)
Main change from baseline of OSDI (Ocular Surface Disease Index) in the worse eye and contralateral eye
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 84 days
Duration of ocular symptoms upon instillation (safety)
Evaluation of duration of ocular symptoms upon instillation in seconds/minutes/hours
Measured: 28 days
Duration of ocular symptoms upon instillation (safety)
Evaluation of duration of ocular symptoms upon instillation in seconds/minutes/hours
Measured: 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)
Measured: 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)
Measured: 84 days
Number of Adverse Events
Collection of ocular and systemic adverse events
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study startJan 2022 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Horus Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hoffart Louis, Principal investigator, Vision Sud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05191771
- Sponsor's protocol ID
- 21E1007
- Status last verified
- Jan 2022
- First submitted
- 10 Dec 2021
- Last updated
- 13 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Depending on any journal publication of the results
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05191771
- Acronym / sponsor ID
- 21E1007
- Conditions
- Dry Eye, Meibomian Gland Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Horus PharmaIndustry (pharma, biotech, devices)
- Study start
- Jan 2022 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 13 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational product | Experimental | Device: Neovis Total Multi |
| Comparator | Active comparator | Device: Systane Balance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Presenting dry eye symptoms for at least 6 months.
- OSDI (Ocular Surface Disease Index) ≥ 18
- At least one eye eligible with:
- 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.
Key exclusion criteria (29 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neovis Total Multi1 drop in each eye, 4 times per day | Device | Investigational product |
| Systane Balance1 drop in each eye, 4 times per day | Device | Comparator |
Primary outcome
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
28 secondary outcomes
Tear-Film Break Up Time (TBUT) (performance)
Time frame: 84 days
Cornea and conjunctiva staining (Oxford score) (performance)
Time frame: 28 days
Cornea and conjunctiva staining (Oxford score) (performance)
Time frame: 84 days
Meibomian gland expression (performance)
Time frame: 28 days
Meibomian gland expression (performance)
Time frame: 84 days
Meibum quality (performance)
Time frame: 28 days
Meibum quality (performance)
Time frame: 84 days
Meiboscopy (performance)
Time frame: 28 days
Meiboscopy (performance)
Time frame: 84 days
Eyelid margin abnormalities (performance)
Time frame: 28 days
Eyelid margin abnormalities (performance)
Time frame: 84 days
OSDI (questionnaire) (performance)
Time frame: 28 days
OSDI (questionnaire) (performance)
Time frame: 84 days
Global performance by the investigator (performance)
Time frame: 28 days
Global performance by the investigator (performance)
Time frame: 84 days
Global performance by the patient (performance)
Time frame: 28 days
Global performance by the patient (performance)
Time frame: 84 days
Global tolerance by the investigator (safety)
Time frame: 28 days
Global tolerance by the investigator (safety)
Time frame: 84 days
Global tolerance by the patient (safety)
Time frame: 28 days
Global tolerance by the patient (safety)
Time frame: 84 days
Intensity of ocular symptoms upon instillation (safety)
Time frame: 28 days
Intensity of ocular symptoms upon instillation (safety)
Time frame: 84 days
Duration of ocular symptoms upon instillation (safety)
Time frame: 28 days
Duration of ocular symptoms upon instillation (safety)
Time frame: 84 days
Frequency of ocular symptoms upon instillation (safety)
Time frame: 28 days
Frequency of ocular symptoms upon instillation (safety)
Time frame: 84 days
Number of Adverse Events
Time frame: 84 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
- Individual participant dataSharing planned: Undecided. Depending on any journal publication of the results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hoffart Louis principal investigator
Vision Sud
Questions about this trial
What is this clinical trial studying?
A study testing Neovis Total Multi and Systane Balance in people with Dry Eye and Meibomian Gland Dysfunction, run by Horus Pharma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laure Chauchat (+33 (0)4 89 08 90 98, laure.chauchat@horus-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tear-Film Break Up Time (TBUT) (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2022.