Dispensing Clinical Trial of Comfilcon A Extended Range Multifocal Lenses
Et udleverings klinisk forsøg med Comfilcon A Extended Range multifokale linser
The aim of this study is to validate the clinical of comfilcon A extended range high add center near (CN) multifocal lenses in existing contact lens wearers against the current comfilcon A high add multifocal lenses.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This study is a 13-subject, randomized, prospective, single site, daily wear, single-masked (to the subject), bilateral, 4-day cross-over, dispensing study comparing the comfilcon A extended range multifocal test lens against the comfilcon A multifocal control lens.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Indiana
-
Bloomington, Indiana, Forenede Stater, 47405
- CORL, Indiana University
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
A person is eligible for inclusion in the study if he/she:
- Has had a self-reported oculo-visual examination in the last two years
- Is 50 years of age or greater and has full legal capacity to volunteer
- Is able to read and understand the informed consent
- Is willing and able to follow instructions and maintain the appointment schedule
- Has a spherical distance contact lens prescription between -1.00 and -5.00D (Diopters) (inclusive)
- Near Add Power requirement of +2.25D or greater
- Has spectacle cylinder 0.75 D in both eyes
- Has normal binocularity (no amblyopia, no strabismus, no habitually uncorrected anisometropia ≥ 2.00D)
- Has monocular best-corrected distance visual acuity of 20/30 or better in each eye
- Has clear corneas and no active ocular disease
- Has not worn gas permeable contact lenses for 1 month prior to the study
Exclusion Criteria:
A person will be excluded from the study if he/she:
- Has never worn contact lenses before
- Has any systemic disease affecting ocular health
- Is using any systemic or topical medications that will affect ocular health
- Has any ocular pathology or abnormality that would affect the wearing of contact lenses
- Is aphakic (i.e. missing their natural lens inside their eye)
- Has uncorrected anisometropia (i.e. difference in the prescription between the eyes) of ≥2.00 D
- Has undergone corneal refractive surgery
- Is participating in any other type of eye related clinical or research study.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: comfilcon A Extended Range test lens
Subjects will be randomized to wear either the test or control pair of lens, then cross over to the alternate pair. |
contact lens contact lens |
|
Aktiv komparator: comfilcon A control lens
Subjects will be randomized to wear either the test or control pair of lens, then cross over to the alternate pair. |
contact lens contact lens |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Visual Acuity
Tidsramme: 4 days
|
Visual acuity was measured at distance, intermediate and near conditions for test and control lens was assessed by LogMAR. |
4 days
|
|
Visual Performance
Tidsramme: 4 days
|
Subjective assessment of visual performance for test and control lens is assessed on a scale 0-100, 0=extremely poor vision all of the time and cannot function, 100= excellent vision all of the time). |
4 days
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Subjective Ratings for Comfort
Tidsramme: Baseline
|
Subjective ratings for comfort was assessed for test and control lens on a Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever). |
Baseline
|
|
Subjective Ratings for Comfort
Tidsramme: 4 days
|
Subjective ratings for comfort was assessed for test and control lens on a Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever). |
4 days
|
|
Subjective Ratings for Dryness
Tidsramme: Baseline
|
Subjective ratings for dryness was assessed for test and control lens on a scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced at any time). |
Baseline
|
|
Subjective Ratings for Dryness
Tidsramme: 4 days
|
Subjective ratings for dryness was assessed for test and control lens on a scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced at any time). |
4 days
|
|
Lens Handling
Tidsramme: 4 Days
|
Subjective ratings for handling (ease of insertion and removal) was assessed for test and control lens on a scale 0-100, 0=very difficult to handle, 100=easy to handle). |
4 Days
|
|
Average Daily Wearing Time
Tidsramme: 4 days
|
Average daily wearing time for test and control lens is assessed in hours. |
4 days
|
|
Lens Fit
Tidsramme: 4 days
|
Lens fit acceptance (general fit characteristics) is assessed for test and control lens on a 0-4 grading system in 0.25 steps where 0 represented very poor fit. |
4 days
|
|
Bulbar Hyperemia
Tidsramme: 4 days
|
Bulbar hyperemia was assessed on a scale of 0-4 and was used in 0.50 steps, with 0 indicating no hyperemia and 4 indicating severe hyperemia. |
4 days
|
|
Limbal Hyperemia
Tidsramme: 4 days
|
Limbal hyperemia was assessed on a scale of 0-4 and was used in 0.50 steps, with 0 indicating no hyperemia and 4 indicating severe hyperemia. |
4 days
|
|
Subjective Satisfaction
Tidsramme: 4 days
|
Subjective satisfaction for test and control lens was assessed on a scale 0-100, 0=extremely dissatisfied, 100=very satisfied) |
4 days
|
|
Subjective Preference for Near Vision
Tidsramme: 4 days
|
Subjective preference for near vision for test and control contact lenses. comfort, vision, handling, satisfaction. |
4 days
|
|
Subjective Preference for Distance Vision
Tidsramme: 4 days
|
Subjective preference for distance vision for test and control contact lenses. |
4 days
|
|
Subjective Preference for Intermediate Vision
Tidsramme: 4 days
|
Subjective preference for intermediate vision for test and control contact lenses. |
4 days
|
|
Subjective Preference for Overall Vision
Tidsramme: 4 days
|
Subjective preference for overall vision for test and control contact lenses. |
4 days
|
|
Subjective Preference for Comfort
Tidsramme: 4 days
|
Subjective preference for comfort for test and control contact lenses. |
4 days
|
|
Subjective Overall Lens Preference
Tidsramme: 4 days
|
Subjective overall lens preference for test and control contact lenses. |
4 days
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Pete S Kollbaum, O.D., Indiana University
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Anslået)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CV-16-02
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret enhedsprodukt
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