Dispensing Study for the Phenacite Project
30. října 2020 aktualizováno: 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.
Přehled studie
Detailní popis
Evaluate the objective and patient-reported visual acceptability of the Phenacite contact lens.
Typ studie
Intervenční
Zápis (Aktuální)
25
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Indiana
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Bloomington, Indiana, Spojené státy, 47405
- Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 35 let (Dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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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Aktivní komparátor: comfilcon A
Subjects will be randomized to wear the comfilcon A contact lenses binocularly.
|
Subjects will be randomized to wear the Phenacite contact lenses binocularly.
Subjects will be randomized to wear the comfilcon A contact lenses binocularly.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Subjective Ratings of Lens Comfort
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 2 weeks
|
Binocular Near Visual Acuity - Low Illumination High Contrast was measured using logMAR
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2 weeks
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Lens Fit - Post Blink Movement
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Pete Kollbaun, OD PhD, CORL Indiana University
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. dubna 2015
Primární dokončení (Aktuální)
1. července 2015
Dokončení studie (Aktuální)
1. července 2015
Termíny zápisu do studia
První předloženo
1. května 2015
První předloženo, které splnilo kritéria kontroly kvality
1. května 2015
První zveřejněno (Odhad)
6. května 2015
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
18. listopadu 2020
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
30. října 2020
Naposledy ověřeno
1. října 2020
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- CV-15-16
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ano
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Phenacite
-
Coopervision, Inc.Dokončeno