Dispensing Study for the Phenacite Project
30. oktober 2020 oppdatert av: CooperVision, Inc.
Dispensing Study for the Phenacite Project.
The investigational test lens was not the final optical design and the study was not used for design validation.
Studieoversikt
Detaljert beskrivelse
Evaluate the objective and patient-reported visual acceptability of the Phenacite contact lens.
Studietype
Intervensjonell
Registrering (Faktiske)
25
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Indiana
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Bloomington, Indiana, Forente stater, 47405
- Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University
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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 til 35 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Oculo-visual examination in the last two years
- Between 18 and 35 years of age and has full legal capacity to volunteer
- Has read and understood the informed consent letter
- Is willing and able to follow instructions and maintain the appointment schedule
- Is correctable to a visual acuity of 20/25 or better (in each eye) with their habitual correction or 20/20 best corrected
- Currently wears, or has previously successfully worn, soft contact lenses between -1.00D and -4.00D
- Spherical Contact Lens Rx between -1.00 and -4.00 and spectacle cylinder ≤-0.75
- Has not worn lenses for at least 12 hours before the initial visit
- Has a subjective response at baseline, which indicates suitability for this study
- Currently spends a minimum of 4 hours a day; 5 days a week on digital devices and can replicate this time during the study period
- Is willing and able to wear the study contact lenses a minimum of 10 hours per day; 5 days a week.
Exclusion Criteria:
- Has never worn contact lenses before
- Any systemic disease affecting ocular health
- Is using any systemic or topical medications that will affect ocular health
- Has known sensitivity to the diagnostic pharmaceuticals or study products used in this study.
- Has any ocular pathology or anomaly that would affect the wearing of the lenses
- Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye
- Is aphakic
- Has anisometropia of >1.00
- Has undergone corneal refractive surgery
- Has strabismus
- Has any ocular amblyopia >= 1line of HC Visual Acuity
- Is participating in any other type of eye related clinical or research study
- Has participated in study CV-14-32.
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: Crossover-oppdrag
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Phenacite
Subjects will be randomized to wear the Phenacite contact lenses binocularly.
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Subjects will be randomized to wear the Phenacite contact lenses binocularly.
Subjects will be randomized to wear the comfilcon A contact lenses binocularly.
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Aktiv komparator: comfilcon A
Subjects will be randomized to wear the comfilcon A contact lenses binocularly.
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Subjects will be randomized to wear the Phenacite contact lenses binocularly.
Subjects will be randomized to wear the comfilcon A contact lenses binocularly.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Subjective Ratings of Lens Comfort
Tidsramme: Baseline (after 15 minutes of lens dispense)
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Subjective ratings of lens comfort.
Comfort Scale (0,100; 0=extremely uncomfortable/cannot tolerate; 100 = extremely comfortable/cannot be felt)
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Baseline (after 15 minutes of lens dispense)
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Subjective Ratings of Lens Comfort
Tidsramme: 2 Weeks
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Subjective ratings of lens comfort.
Comfort Scale (0,100; 0=extremely uncomfortable/cannot tolerate; 100 = extremely comfortable/cannot be felt)
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2 Weeks
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Over Refraction for Optimized Distance Acuity
Tidsramme: 2 weeks
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Over Refraction for optimized distance acuity measured using logMAR
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2 weeks
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Binocular Distance Visual Acuity - High Illumination High Contrast
Tidsramme: Baseline (after 5 minutes of lens dispense)
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Binocular Distance Visual Acuity - High Illumination High Contrast was measured using logMAR
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Baseline (after 5 minutes of lens dispense)
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Binocular Distance Visual Acuity - High Illumination High Contrast
Tidsramme: 2 weeks
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Binocular Distance Visual Acuity - High Illumination High Contrast was measured using logMAR
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2 weeks
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Binocular Distance Visual Acuity - Low Illumination High Contrast
Tidsramme: Baseline (after 5 minutes of lens dispense)
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Binocular Distance Visual Acuity - Low Illumination High Contrast was measured using logMAR
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Baseline (after 5 minutes of lens dispense)
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Binocular Distance Visual Acuity - Low Illumination High Contrast
Tidsramme: 2 weeks
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Binocular Distance Visual Acuity - Low Illumination High Contrast was measured using logMAR
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2 weeks
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Binocular Near Visual Acuity - High Illumination High Contrast
Tidsramme: Baseline (after 5 minutes of lens dispense)
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Binocular Near Visual Acuity - High Illumination High Contrast was measured using logMAR
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Baseline (after 5 minutes of lens dispense)
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Binocular Near Visual Acuity - High Illumination High Contrast
Tidsramme: 2 weeks
|
Binocular Near Visual Acuity - High Illumination High Contrast was measured using logMAR
|
2 weeks
|
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Binocular Near Visual Acuity - Low Illumination High Contrast
Tidsramme: Baseline (after 5 minutes of lens dispense)
|
Binocular Near Visual Acuity - Low Illumination High Contrast was measured using logMAR
|
Baseline (after 5 minutes of lens dispense)
|
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Binocular Near Visual Acuity - Low Illumination High Contrast
Tidsramme: 2 weeks
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Binocular Near Visual Acuity - Low Illumination High Contrast was measured using logMAR
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2 weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Lens Fit - Post Blink Movement
Tidsramme: Baseline (after 15 minutes of lens dispense)
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Investigator assessment of Amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)
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Baseline (after 15 minutes of lens dispense)
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Lens Fit - Post Blink Movement
Tidsramme: 2 weeks
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Investigator assessment of Amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)
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2 weeks
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Push - Up Test for Lens Tightness
Tidsramme: Baseline (after 15 minutes of lens dispense)
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Investigator assessment using Continuous Scale 0-100% (1% steps): 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement
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Baseline (after 15 minutes of lens dispense)
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Push - Up Test for Lens Tightness
Tidsramme: 2 weeks
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Investigator assessment using Continuous Scale 0-100% (1% steps): 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement
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2 weeks
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Lens Mobility Rating
Tidsramme: Baseline (after 15 minutes of lens dispense)
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Investigator assessment using 5 Categories in 0.50 steps: 0=Immobile - no lag in any versions, 1=Restricted - no lag in some directions but slight lag (0-0.25mm) in others, 2=Secure - slight lag (0.25-0.5mm in each version), 3=Unrestricted - freely lags in a controlled manner on all versions, but not excessive (0.5-1.0mm), 4=Very mobile - excessive lag (>1mm) on versions in all directions in 0.25 steps
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Baseline (after 15 minutes of lens dispense)
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Lens Mobility Rating
Tidsramme: 2 weeks
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Investigator assessment using 5 Categories in 0.50 steps: 0=Immobile - no lag in any versions, 1=Restricted - no lag in some directions but slight lag (0-0.25mm) in others, 2=Secure - slight lag (0.25-0.5mm in each version), 3=Unrestricted - freely lags in a controlled manner on all versions, but not excessive (0.5-1.0mm), 4=Very mobile - excessive lag (>1mm) on versions in all directions in 0.25 steps
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2 weeks
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Overall Lens Fit Acceptance
Tidsramme: Baseline (after 15 minutes of lens dispense)
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Investigator assessment using 5 Categories in 0.25 steps: 0=Can't be worn, 1=Poor - should not be dispensed although no immediate danger, 2=Fair, 3=Good, 4=Optimum in 0.25 steps
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Baseline (after 15 minutes of lens dispense)
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Overall Lens Fit Acceptance
Tidsramme: 2 weeks
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Investigator assessment using 5 Categories in 0.25 steps: 0=Can't be worn, 1=Poor - should not be dispensed although no immediate danger, 2=Fair, 3=Good, 4=Optimum in 0.25 steps
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2 weeks
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Subjective Ratings for Vision Quality - Distance Vision
Tidsramme: Baseline (after 15 minutes of lens dispense)
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Patient subjective scoring using 0-100 continuous scale for Distance Quality of Vision: 0=extremely poor vision all of the time.
Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
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Baseline (after 15 minutes of lens dispense)
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Subjective Ratings for Vision Quality - Distance Vision
Tidsramme: 2 weeks
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Patient subjective scoring using 0-100 continuous scale for Distance Quality of Vision: 0=extremely poor vision all of the time.
Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
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2 weeks
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Subjective Ratings for Vision Quality - Near Vision
Tidsramme: Baseline (after 15 minutes of lens dispense)
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Patient subjective scoring using 0-100 continuous scale for Near Quality of Vision: 0=extremely poor vision all of the time.
Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
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Baseline (after 15 minutes of lens dispense)
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Subjective Ratings for Vision Quality - Near Vision
Tidsramme: 2 weeks
|
Patient subjective scoring using 0-100 continuous scale for Near Quality of Vision: 0=extremely poor vision all of the time.
Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
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2 weeks
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Subjective Ratings for Vision Quality - Computer Vision
Tidsramme: Baseline (after 15 minutes of lens dispense)
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Patient subjective scoring using 0-100 continuous scale for Computer Vision: 0=extremely poor vision all of the time.
Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
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Baseline (after 15 minutes of lens dispense)
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Subjective Ratings for Vision Quality - Computer Vision
Tidsramme: 2 weeks
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Patient subjective scoring using 0-100 continuous scale for Computer Vision: 0=extremely poor vision all of the time.
Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
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2 weeks
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Subjective Ratings for Vision Quality - Overall Vision
Tidsramme: Baseline (after 15 minutes of lens dispense)
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Patient subjective scoring using 0-100 continuous scale for Overall Vision: 0=extremely poor vision all of the time.
Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
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Baseline (after 15 minutes of lens dispense)
|
|
Subjective Ratings for Vision Quality - Overall Vision
Tidsramme: 2 weeks
|
Patient subjective scoring using 0-100 continuous scale for Overall Vision: 0=extremely poor vision all of the time.
Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
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2 weeks
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Corneal Staining Extent
Tidsramme: 2 weeks
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Corneal staining extent was assessed on a scale of 0-4 (0-No Staining, 1 - 1-15% of area, 2- 16-30% of area, 3- 31-45% of area, 4- >45% of area
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2 weeks
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Conjunctival Staining
Tidsramme: 2 weeks
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Conjunctival staining was assessed on a scale of 0-4, 0.50 steps (0-None, 1 - Minimal diffuse punctuate, 2- Coalescent Punctuate, 3- confluent, 4- Deep confluent
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2 weeks
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Pete Kollbaun, OD PhD, CORL Indiana University
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
1. april 2015
Primær fullføring (Faktiske)
1. juli 2015
Studiet fullført (Faktiske)
1. juli 2015
Datoer for studieregistrering
Først innsendt
1. mai 2015
Først innsendt som oppfylte QC-kriteriene
1. mai 2015
Først lagt ut (Anslag)
6. mai 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
18. november 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
30. oktober 2020
Sist bekreftet
1. oktober 2020
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CV-15-16
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Ja
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