Dispensing Study for the Phenacite Project
2020. október 30. frissítette: 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.
A tanulmány áttekintése
Részletes leírás
Evaluate the objective and patient-reported visual acceptability of the Phenacite contact lens.
Tanulmány típusa
Beavatkozó
Beiratkozás (Tényleges)
25
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi helyek
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Indiana
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Bloomington, Indiana, Egyesült Államok, 47405
- Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University
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Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
18 év (Felnőtt)
Egészséges önkénteseket fogad
Nem
Tanulmányozható nemek
Összes
Leírás
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.
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Crossover kiosztás
- Maszkolás: Kettős
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Kísérleti: 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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Aktív összehasonlító: 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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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Subjective Ratings of Lens Comfort
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 2 weeks
|
Binocular Near Visual Acuity - High Illumination High Contrast was measured using logMAR
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2 weeks
|
|
Binocular Near Visual Acuity - Low Illumination High Contrast
Időkeret: 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
Időkeret: 2 weeks
|
Binocular Near Visual Acuity - Low Illumination High Contrast was measured using logMAR
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2 weeks
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Lens Fit - Post Blink Movement
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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)
|
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Subjective Ratings for Vision Quality - Overall Vision
Időkeret: 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
Időkeret: 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
Időkeret: 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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Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Nyomozók
- Kutatásvezető: Pete Kollbaun, OD PhD, CORL Indiana University
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete
2015. április 1.
Elsődleges befejezés (Tényleges)
2015. július 1.
A tanulmány befejezése (Tényleges)
2015. július 1.
Tanulmányi regisztráció dátumai
Először benyújtva
2015. május 1.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2015. május 1.
Első közzététel (Becslés)
2015. május 6.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2020. november 18.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2020. október 30.
Utolsó ellenőrzés
2020. október 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- CV-15-16
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