- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07443215
Bewertung der Auswirkungen von Streulicht auf die visuelle Leistung
Evaluation der Auswirkung von Streuung auf die visuelle Leistungsfähigkeit
This will be a 3-visit, single-site, randomized, single-masked, bilateral wear, non-dispensing, crossover study which will evaluate visual performance with different magnitudes of scatter.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Optical scatter may affect young adults or non-presbyopes and older adults or presbyopes differently. Intrinsic ocular scatter increases with age and ocular scatter sensitivity as well as profile is different in younger adults and older adults.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
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Florida
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Jacksonville, Florida, Vereinigte Staaten, 32256
- VRC
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-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
- Read, understand, and sign the Statement of Informed Consent and receive a fully executed copy of the form.
- Appear able and willing to adhere to the instructions set forth in this clinical protocol.
- Be between 18 and 69 years of age (inclusive) at the time of screening.
- Habitually wear soft contact lenses (either spherical or multifocal) in both eyes in a daily reusable or daily disposable wear modality (i.e., not extended wear modality). Habitual wearer is defined as a minimum of 6 hours per day, for a minimum of 2 days per week during the past 30 days.
- Possess a wearable pair of spectacles that provide correction for distance vision.
- Have the spherical component of their vertex-corrected distance refraction within the range +3.00 to -5.00 DS (inclusive) in both eyes.
- Have the magnitude of the cylindrical component of their vertex-corrected distance refraction below 1.00 DC in both eyes.
- Have best corrected monocular distance VA of 20/25 or better in each eye.
- Have Near Addition with Add refinement following BCC<0.75D (Non-presbyopic group only).
- Have Near Addition with Add refinement following BCC≥0.75D (Presbyopic group only).
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- Be currently pregnant or lactating.
- Be diabetic.
- Be currently using any ocular medications or have an ocular infection of any type.
- Have any ocular or systemic allergies, disease, infection, or use of medication that might contraindicate or interfere with contact lens wear or otherwise compromise study endpoints, including infectious diseases (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus [HIV]), or history of serious mental illness or seizures. See section 9.1 for additional details regarding systemic medications.
- Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g., SynergEyes, SoftPerm) within the past 6 months.
- Be currently wearing lenses in an extended wear modality.
- Have a history of strabismus or amblyopia.
- Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site.
- Have participated in a contact lens or lens care product clinical trial within 7 days prior to study enrollment.
- Have clinically significant (Grade 3 or 4 on the FDA classification scale) slit lamp findings (e.g. corneal edema, neovascularization or staining, tarsal abnormalities or bulbar injection) or other corneal or ocular disease or abnormalities that may contraindicate contact lens wear or otherwise compromise study endpoints (including entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, moderate or above corneal distortion, herpetic keratitis).
- Have fluctuations in vision due to clinically significant dry eye or other ocular conditions.
- Have had or have planned (within the study period) ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: No filter/Filter 1/4mm/Filter 1/2mm/Filter 1mm/Filter 2mm
Eligible subjects will be randomly assigned to the No filter/Filter 1/4mm/Filter 1/2mm/Filter 1mm/Filter 2mm sequence |
Lens for non-Presbyopes Lens for Prebyopes |
|
Experimental: Filter 1/4mm/Filter 1/2mm/Filter 1mm/Filter 2mm/No filter
Eligible subjects will be randomly assigned to the Filter 1/4mm/Filter 1/2mm/Filter 1mm/Filter 2mm/No filter sequence |
Lens for non-Presbyopes Lens for Prebyopes |
|
Experimental: Filter 1/2mm/Filter 1mm/Filter 2mm/No filter/Filter 1/4mm
Eligible subjects will be randomly assigned to the Filter 1/2mm/Filter 1mm/Filter 2mm/No filter/Filter 1/4mm sequence |
Lens for non-Presbyopes Lens for Prebyopes |
|
Experimental: Filter 1mm/Filter 2mm/No filter/Filter 1/4mm/Filter 1/2mm
Eligible subjects will be randomly assigned to the Filter 1mm/Filter 2mm/No filter/Filter 1/4mm/Filter 1/2mm sequence |
Lens for non-Presbyopes Lens for Prebyopes |
|
Experimental: Filter 2mm/No filter/Filter 1/4mm/Filter 1/2mm/Filter 1mm
Eligible subjects will be randomly assigned to the Filter 2mm/No filter/Filter 1/4mm/Filter 1/2mm/Filter 1mm sequence |
Lens for non-Presbyopes Lens for Prebyopes |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Distance Monocular High luminance high contrast (HLHC) logMAR Visual acuity (VA)
Zeitfenster: Day 1 Post lens fitting
|
Distance (4 meters) Monocular High luminance high contrast (HLHC) logMAR Visual acuity (VA) without glare will be assessed after lens fitting. |
Day 1 Post lens fitting
|
Mitarbeiter und Ermittler
Ermittler
- Studienleiter: Johnson & Johnson Vision Care, Inc. Clinical Trial, Johnson & Johnson Vision Care, Inc.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- CR-6626
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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