- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05191771
Evaluation of Neovis® Total Multi Versus Systane® Balance on Ocular Dryness Associated With Meibomian Gland Dysfunction
3. januar 2022 oppdatert av: Horus Pharma
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.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Forventet)
120
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Laure Chauchat
- Telefonnummer: +33 (0)4 89 08 90 98
- E-post: laure.chauchat@horus-pharma.com
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Undersøkende produkt
|
1 drop in each eye, 4 times per day
|
Aktiv komparator: Komparator
|
1 drop in each eye, 4 times per day
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Tear-Film Break Up Time (TBUT)
Tidsramme: 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 days
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Tear-Film Break Up Time (TBUT) (ytelse)
Tidsramme: 84 dager
|
Hovedendring fra baseline av Tear-Film Break Up Time (TBUT) i det dårligste øyet og det kontralaterale øyet
|
84 dager
|
Cornea and conjunctiva staining (Oxford score) (performance)
Tidsramme: 28 days
|
Main change from baseline of cornea and conjunctiva staining (Oxford score) in the worse eye and contralateral eye
|
28 days
|
Hornhinne- og konjunktiva-farging (Oxford-score) (ytelse)
Tidsramme: 84 dager
|
Hovedendring fra baseline av hornhinne- og konjunktiva-farging (Oxford-score) i det dårligere øyet og det kontralaterale øyet
|
84 dager
|
Meibomian gland expression (performance)
Tidsramme: 28 days
|
Main change from baseline of meibomian gland expression score in the worse eye and contralateral eye
|
28 days
|
Meibomian gland expression (performance)
Tidsramme: 84 days
|
Main change from baseline of meibomian gland expression score in the worse eye and contralateral eye
|
84 days
|
Meibum quality (performance)
Tidsramme: 28 days
|
Main change from baseline of meibum quality score in the worse eye and contralateral eye
|
28 days
|
Meibum quality (performance)
Tidsramme: 84 days
|
Main change from baseline of meibum quality score in the worse eye and contralateral eye
|
84 days
|
Meiboscopy (performance)
Tidsramme: 28 days
|
Main change from baseline of the number of partially missing or dropout meibomian glands in the worse eye and contralateral eye
|
28 days
|
Meiboscopy (performance)
Tidsramme: 84 days
|
Main change from baseline of the number of partially missing or dropout meibomian glands in the worse eye and contralateral eye
|
84 days
|
Eyelid margin abnormalities (performance)
Tidsramme: 28 days
|
Main change from baseline of the eyelid margin abnormalities score in the worse eye and contralateral eye
|
28 days
|
Eyelid margin abnormalities (performance)
Tidsramme: 84 days
|
Main change from baseline of the eyelid margin abnormalities score in the worse eye and contralateral eye
|
84 days
|
OSDI (questionnaire) (performance)
Tidsramme: 28 days
|
Main change from baseline of OSDI (Ocular Surface Disease Index) in the worse eye and contralateral eye
|
28 days
|
OSDI (questionnaire) (performance)
Tidsramme: 84 days
|
Main change from baseline of OSDI (Ocular Surface Disease Index) in the worse eye and contralateral eye
|
84 days
|
Global performance by the investigator (performance)
Tidsramme: 28 days
|
Global performance assessment by the investigator using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
|
28 days
|
Global ytelse av etterforskeren (ytelse)
Tidsramme: 84 dager
|
Global ytelsesvurdering av etterforskeren ved hjelp av en 4-punkts skala (Utilfredsstillende, Ikke veldig tilfredsstillende, Tilfredsstillende, Svært tilfredsstillende)
|
84 dager
|
Global performance by the patient (performance)
Tidsramme: 28 days
|
Global performance assessment by the patient using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
|
28 days
|
Global performance by the patient (performance)
Tidsramme: 84 days
|
Global performance assessment by the patient using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
|
84 days
|
Global tolerance by the investigator (safety)
Tidsramme: 28 days
|
Global tolerance assessment by the investigator using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
|
28 days
|
Global tolerance by the investigator (safety)
Tidsramme: 84 days
|
Global tolerance assessment by the investigator using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
|
84 days
|
Global tolerance by the patient (safety)
Tidsramme: 28 days
|
Global tolerance assessment by the patient using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
|
28 days
|
Global tolerance by the patient (safety)
Tidsramme: 84 days
|
Global tolerance assessment by the patient using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
|
84 days
|
Intensity of ocular symptoms upon instillation (safety)
Tidsramme: 28 days
|
Evaluation of intensity of ocular symptoms upon instillation on a scale from 0 (none) to 3 (severe)
|
28 days
|
Intensity of ocular symptoms upon instillation (safety)
Tidsramme: 84 days
|
Evaluation of intensity of ocular symptoms upon instillation on a scale from 0 (none) to 3 (severe)
|
84 days
|
Duration of ocular symptoms upon instillation (safety)
Tidsramme: 28 days
|
Evaluation of duration of ocular symptoms upon instillation in seconds/minutes/hours
|
28 days
|
Duration of ocular symptoms upon instillation (safety)
Tidsramme: 84 days
|
Evaluation of duration of ocular symptoms upon instillation in seconds/minutes/hours
|
84 days
|
Frequency of ocular symptoms upon instillation (safety)
Tidsramme: 28 days
|
Evaluation of frequency of ocular symptoms upon instillation on a scale from 1 (rarely) to 4 (very often)
|
28 days
|
Frequency of ocular symptoms upon instillation (safety)
Tidsramme: 84 days
|
Evaluation of frequency of ocular symptoms upon instillation on a scale from 1 (rarely) to 4 (very often)
|
84 days
|
Number of Adverse Events
Tidsramme: 84 days
|
Collection of ocular and systemic adverse events
|
84 days
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Non-Invasive Tear film Break-Up Time (NIBUT) (exploratory, optional)
Tidsramme: 28 days
|
Main change from baseline of Non-Invasive Tear film Break-Up Time (NIBUT) in the worse eye and contralateral eye
|
28 days
|
Non-Invasive Tear film Break-Up Time (NIBUT) (exploratory, optional)
Tidsramme: 84 days
|
Main change from baseline of Non-Invasive Tear film Break-Up Time (NIBUT) in the worse eye and contralateral eye
|
84 days
|
Lipid layer thickness (exploratory, optional)
Tidsramme: 28 days
|
Main change from baseline of lipid layer thickness with interferometry methods in the worse eye and contralateral eye
|
28 days
|
Lipid layer thickness (exploratory, optional)
Tidsramme: 84 days
|
Main change from baseline of lipid layer thickness with interferometry methods in the worse eye and contralateral eye
|
84 days
|
Functional visual acuity (exploratory, optional)
Tidsramme: 28 days
|
Main change from baseline of functional visual acuity in the worse eye and contralateral eye
|
28 days
|
Functional visual acuity (exploratory, optional)
Tidsramme: 84 days
|
Main change from baseline of functional visual acuity in the worse eye and contralateral eye
|
84 days
|
Super Oxyde Dismutase (SOD) dosage (exploratory, optional)
Tidsramme: 84 days
|
Main change from baseline of SOD1 and SOD2 in the worse eye
|
84 days
|
Goblet cells analysis (exploratory, optional)
Tidsramme: 84 days
|
Main change from baseline of Goblet cells in the worse eye
|
84 days
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Hoffart Louis, Vision Sud
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Forventet)
1. januar 2022
Primær fullføring (Forventet)
1. oktober 2022
Studiet fullført (Forventet)
1. desember 2022
Datoer for studieregistrering
Først innsendt
10. desember 2021
Først innsendt som oppfylte QC-kriteriene
3. januar 2022
Først lagt ut (Faktiske)
13. januar 2022
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
13. januar 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. januar 2022
Sist bekreftet
1. januar 2022
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 21E1007
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Ubestemt
IPD-planbeskrivelse
Depending on any journal publication of the results
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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