- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07722624
A Single Center, Open-Label Study to Evaluate the Ability of the TearScience™ LipiView™ II Ocular Surface Interferometer and the Keratograph® 5M to Detect Tear Film Stability Utilizing Miebo® (TFSTAB)
28. juli 2026 opdateret af: The Eye Care Institute
A study to investigate the ability of the TearScience™ LipiView™ II Ocular Surface Interferometer and the Keratograph® 5M to detect tear film stability utilizing Miebo®
Studieoversigt
Status
Aktiv, ikke rekrutterende
Betingelser
Detaljeret beskrivelse
Determine the ability of the TearScience™ LipiView™ II Ocular Surface Interferometer and the Keratograph® 5M to detect tear film stability utilizing Miebo® by examining potential differences in various tear film assessments before dosing Miebo® and at multiple timepoints post-Miebo® dosing
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
20
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Kentucky
-
Louisville, Kentucky, Forenede Stater, 40206
- Butchertown Clinical Trials
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
Inclusion Criteria:
- At least 18 years of age at the time of consent
- Able to provide written voluntary informed consent
- Must have a normal pre-corneal tear film in one or both eyes[MC4.1][AA4.2]
- Subjects cannot have instilled any topical ocular drops (including OTC lubricant drops) within 24 hours of the study visit.
- Able and willing to follow instructions, including participation in all trial assessments and visits
Exclusion Criteria:
Have any clinically significant ocular surface slit-lamp findings in either eye and/or, in the opinion of the Investigator, have any findings that could interfere with trial parameters including:
- History of Stevens-Johnson syndrome
- Active blepharitis or lid margin inflammation
- DED secondary to scarring, irradiation, alkali burns, cicatricial pemphigoid, or destruction of conjunctival goblet cells (as with vitamin A deficiency)
- Abnormal lid anatomy causing incomplete eyelid closure
- Abnormal cornea shape (keratoconus)
- Corneal epithelial defect or significant confluent staining or filaments
- History of ocular malignancy
- Pterygium in either eye
- Use of any of the following ocular therapies in the study eye within 24 hours prior to Visit 1: Vuity®, VIZZ™, topical ocular steroid treatments, topical antibiotics, prescription dry eye therapy including varenicline nasal spray, over the counter dry eye therapy (such as artificial tears, re-wetting drops, or Lumify®), TrueTear™ device (intranasal tear neurostimulator), or topical anti-glaucoma medication
- Have active uncontrolled ocular allergies or ocular allergies that are expected to be active during the trial period
- Have undergone intraocular surgery or ocular laser surgery in the study eye within 3 months prior to Visit 1; have undergone refractive surgery in the study eye within 6 months prior to Visit 1
- Have worn contact lenses within 24 hours prior to Visit 1.
- Have active ocular or systemic infection (bacterial, viral, or fungal), including fever
- Female subjects who are pregnant, nursing, or planning a pregnancy
- Female subjects of childbearing potential who are not using an acceptable means of birth control; acceptable methods of contraception include hormonal (oral, implantable, injectable, or transdermal) contraception; mechanical (spermicide in conjunction with a barrier such as a diaphragm or condom) contraception; intrauterine device; or surgical sterilization of partner. For non-sexually active female subjects, abstinence may be regarded as an adequate method of birth control; however, if the subject becomes sexually active during the trial, she must agree to use adequate birth control as defined above for the remainder of the trial
- Have an uncontrolled systemic disease that, in the opinion of the Investigator, will interfere with the trial
- Have a known allergy and/or sensitivity to the investigational product or diagnostic substances (e.g. fluorescein) to be used in the study
- Are currently enrolled in any investigational or device study or have used Miebo® within 24 hours prior to Visit
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Determine the ability of the TearScience™ LipiView™ II Ocular Surface Interferometer and the Keratog
Determine the ability of the TearScience™ LipiView™ II Ocular Surface Interferometer and the Keratograph® 5M to detect tear film stability utilizing Miebo® by examining potential differences in various tear film assessments before dosing Miebo® and at multiple timepoints post-Miebo® dosing
|
Determine the ability of the TearScience™ LipiView™ II Ocular Surface Interferometer and the Keratograph® 5M to detect tear film stability utilizing Miebo® by examining potential differences in various tear film assessments before dosing Miebo® and at multiple timepoints post-Miebo® dosing
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Assess the effect of Miebo® on the TearScience™ LipiView™ II Ocular Surface Interferometer Lipid Layer Thickness (LLT) Evaluation
Tidsramme: 1 hour
|
Number of subjects with an increase from baseline in lipid layer thickness as assessed by the TearScience™ LipiView™ II Ocular Surface Interferometer
|
1 hour
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
26. juni 2026
Primær færdiggørelse (Anslået)
30. juli 2026
Studieafslutning (Anslået)
30. august 2026
Datoer for studieregistrering
Først indsendt
22. juni 2026
Først indsendt, der opfyldte QC-kriterier
22. juli 2026
Først opslået (Faktiske)
23. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
29. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- BL-RX01-TFSTAB-1401
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
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