- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT02060539
Multicenter Dispensing Study of Biofinity Lenses in Extended Range
8 listopada 2017 zaktualizowane przez: Coopervision, Inc.
To obtain subjective and objective feedback on the clinical performance of Biofinity lenses after at least two weeks daily wear in existing contact lens wearers compared with their habitual lenses.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
19
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Ontario
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Waterloo, Ontario, Kanada, N2L 3G1
- CCLR, University of Waterloo
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California
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Berkeley, California, Stany Zjednoczone, 94720-2020
- UC Berkeley Clinica Research Center
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Indiana
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Indianapolis, Indiana, Stany Zjednoczone, 46266-6057
- CORL, Indiana University School of Optometry
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Texas
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Houston, Texas, Stany Zjednoczone, 77204-2020
- TERTC, University of Houston
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
Inclusion Criteria:
- Has had an oculo-visual examination in the last two years
- Is at least 18 years of age and has full legal capacity to volunteer
- Has read and understood the information consent letter
- Is willing and able to follow instructions and maintain the appointment schedule
- Is correctable to a visual acuity of 20/50 or better (in at least one eye) with their habitual vision correction
- Currently wears soft contact lenses
- They should require contact lens powers between -12.00 and -20.00D or between +8.00 and +15.00D
- Has clear corneas and no active ocular disease
- Demonstrates an acceptable fit with the study lenses.
Exclusion Criteria:
- Has any systemic disease affecting ocular health
- Is taking medication, such as antihistamine eye drops, oral and ophthalmic betaadrenergic blockers (e.g. Propanolol, Timolol), anticholinergics, and any prescribed or over-the-counter eye medication, except artificial tears or eye lubricants
- Have any active ocular disease and/or infection that would contraindicate contact lens wear.
- Active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
- Has worn gas permeable contact lenses within the last month.
- Is aphakic
- Has undergone corneal refractive surgery.
- Is participating in any other type of clinical research study
- Female who is currently pregnant or is breast-feeding.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Biofinity XR
Participants dispensed Biofinity XR lenses over two weeks of lens wear
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Dryness (During Day and Dryness at Night)
Ramy czasowe: Baseline
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Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn, Extremely dry.
100=No dryness experienced at any time.)
Obtained habitual lens history at baseline.
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Baseline
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Dryness (During Day)
Ramy czasowe: Dispense
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Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn, Extremely dry.
100=No dryness experienced at any time.)
Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
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Dispense
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Dryness (During Day and Dryness at Night)
Ramy czasowe: 2 Weeks
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Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn, Extremely dry.
100=No dryness experienced at any time.)
Obtained at two weeks.
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2 Weeks
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Comfort (Insertion, End of Day, Overall)
Ramy czasowe: Baseline
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Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained habitual lens history at baseline.
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Baseline
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Comfort (Insertion)
Ramy czasowe: Dispense
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Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
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Dispense
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Comfort (Insertion, End of Day, Overall)
Ramy czasowe: 2 Weeks
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Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained at 2 weeks.
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2 Weeks
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Ghosting (Multiple Images)
Ramy czasowe: Baseline
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Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreame ghosting.
Cannot be worn.
100=No ghosting ever.)
Obtained habitual lens history at baseline.
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Baseline
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Ghosting (Multiple Images)
Ramy czasowe: Dispense
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Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreme ghosting.
Cannot be worn.
100=No ghosting ever.)
Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
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Dispense
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Ghosting (Multiple Images)
Ramy czasowe: 2 Weeks
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Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreme ghosting.
Cannot be worn.
100=No ghosting ever.)
Obtained at 2 weeks.
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2 Weeks
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Hazing (Blurred Edges)
Ramy czasowe: Baseline
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Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreame haze.
Cannot be worn.
100=No hazing experienced at any time.)
Obtained habitual lens history at baseline.
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Baseline
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Hazing (Blurred Edges)
Ramy czasowe: 2 Weeks
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Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreme haze.
Cannot be worn.
100=No hazing experienced at any time.)
Obtained at 2 weeks.
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2 Weeks
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Vision Quality (During Day and at Night)
Ramy czasowe: Baseline
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Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely poor vision all the time.
Cannot function; 100=Excellent vision all of the time.)
Obtained habitual lens history at baseline.
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Baseline
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Vision Quality (During Day)
Ramy czasowe: Dispense
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Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely poor vision all the time.
Cannot function; 100=Excellent vision all of the time.)
Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
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Dispense
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Vision Quality (During Day and at Night)
Ramy czasowe: 2 Weeks
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Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely poor vision all the time.
Cannot function; 100=Excellent vision all of the time.)
Obtained at 2 weeks.
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2 Weeks
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Handling (Insertion, Removal, Overall)
Ramy czasowe: Baseline
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Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained habitual lens history at baseline.
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Baseline
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Handling (Insertion, Removal, Overall)
Ramy czasowe: 2 weeks
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Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained at 2 weeks.
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2 weeks
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Overall Satisfaction of Comfort, Vision, Handling
Ramy czasowe: Dispense
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Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely dissatisfied; 100=Extremely satisfied.)
Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
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Dispense
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Overall Satisfaction of Comfort, Vision, Handling
Ramy czasowe: Baseline
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Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely dissatisfied; 100=Extremely satisfied.)
Obtained habitual lens history at baseline.
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Baseline
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Overall Satisfaction of Comfort, Vision, Handling
Ramy czasowe: 2 Weeks
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Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely dissatisfied; 100=Extremely satisfied.)
Obtained at baseline at 2 weeks.
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2 Weeks
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Comfort Preference
Ramy czasowe: Dispense
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Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
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Dispense
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Comfort Preference
Ramy czasowe: 2 Weeks
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Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.
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2 Weeks
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Vision Preference
Ramy czasowe: Dispense
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Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
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Dispense
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Vision Preference
Ramy czasowe: 2 Weeks
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Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.
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2 Weeks
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Handling Preference
Ramy czasowe: 2 Weeks
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Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.
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2 Weeks
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Overall Preference
Ramy czasowe: Dispense
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Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
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Dispense
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Overall Preference
Ramy czasowe: 2 Weeks
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Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.
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2 Weeks
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Lens Centration - Habitual Lenses
Ramy czasowe: Baseline
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Objective measurement by investigator.
(Assessed as optimum, slightly decentered, extremely decentered) Obtained for habitual lenses at baseline.
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Baseline
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Lens Centration
Ramy czasowe: Dispense
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Objective measurement by investigator.
(Assessed as optimum, slightly decentered, extremely decentered) Obtained at baseline at dispense.
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Dispense
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Lens Centration
Ramy czasowe: 2 Weeks
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Objective measurement by investigator.
(Assessed as optimum, slightly decentered, extremely decentered) Obtained at 2 weeks.
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2 Weeks
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Lens Movement - Habitual Lenses
Ramy czasowe: Baseline
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Objective measurement by investigator of overall post-blink lens movement.
(Average Grade; Graded 0-4; 0=exceptionally tight, 2=optimal, 4=exceptionally loose) Obtained for habitual lenses at baseline.
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Baseline
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Lens Movement
Ramy czasowe: Dispense
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Objective measurement by investigator of overall post-blink lens movement.
(Average Grade; Graded 0-4; 0=exceptionally tight, 2=optimal, 4=exceptionally loose) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
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Dispense
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Lens Movement
Ramy czasowe: 2 Weeks
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Objective measurement by investigator of overall post-blink lens movement.
(Average Grade; Graded 0-4; 0=exceptionally tight, 2=optimal, 4=exceptionally loose) Obtained at 2 weeks wear.
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2 Weeks
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Overall Fit Acceptance
Ramy czasowe: Baseline
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Objective measurement by investigator of overall fit acceptance.
(scale 0-4; 0=very poor, 4=very good) Obtained for habitual lenses at baseline.
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Baseline
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Overall Fit Acceptance
Ramy czasowe: Dispense
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Objective measurement by investigator of overall fit acceptance.
(scale 0-4; 0=very poor, 4=very good) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
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Dispense
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Overall Fit Acceptance
Ramy czasowe: 2 Weeks
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Objective measurement by investigator of overall fit acceptance.
(scale 0-4; 0=very poor, 4=very good) Obtained at 2 weeks.
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2 Weeks
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Visual Acuity
Ramy czasowe: Baseline
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Objective measurement by investigator of monocular high and low contrast logMar visual acuity.
Visual Acuity High-Contrast (VA HC), Visual Acuity Low-Contrast (VA LC), Visual Acuity High-Contrast OU (VA HC OU), Visual Acuity Low-Contrast OU (VA LC OU).
Obtained for habitual lenses at baseline.
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Baseline
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Visual Acuity
Ramy czasowe: Dispense
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Objective measurement by investigator of monocular high and low contrast logMar visual acuity.
Visual Acuity High-Contrast (VA HC), Visual Acuity Low-Contrast (VA LC), Visual Acuity High-Contrast OU (VA HC OU), Visual Acuity Low-Contrast OU (VA LC OU).
Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
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Dispense
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Visual Acuity
Ramy czasowe: 2 Weeks
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Objective measurement by investigator of monocular high and low contrast logMar visual acuity.
Visual Acuity High-Contrast (VA HC), Visual Acuity Low-Contrast (VA LC), Visual Acuity High-Contrast OU (VA HC OU), Visual Acuity Low-Contrast OU (VA LC OU).
Obtained at 2 weeks.
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2 Weeks
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Anterior Ocular Physiological Response
Ramy czasowe: Baseline
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Ocular response assessed with the slit lamp using a Visual Analog Scale (0-4, 0=none, 4=severe).
Obtained for habitual lenses at baseline.
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Baseline
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Anterior Ocular Physiological Response
Ramy czasowe: 2 Weeks
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Ocular response assessed with the slit lamp using a Visual Analog Scale (0-4, 0=none, 4=severe).
Obtained at 2 weeks.
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2 Weeks
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Average Wearing Time
Ramy czasowe: Baseline
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Participant response when asked, "Number of hours worn today?" (hours per day) Obtained for habitual lens at baseline.
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Baseline
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Average Wearing Time
Ramy czasowe: 2 Weeks
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Participant response when asked, "Number of hours worn today?" (hours per day) Obtained at 2 weeks.
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2 Weeks
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Główny śledczy: Lyndon Jones, CCLR, University of Waterloo
- Główny śledczy: Meng Lin, CRC, University of California Berkeley
- Główny śledczy: Jan Bergmanson, TERTC, University of Houston
- Główny śledczy: Pete Kollbaum, CORL, Indiana University
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 października 2013
Zakończenie podstawowe (Rzeczywisty)
1 kwietnia 2014
Ukończenie studiów (Rzeczywisty)
1 grudnia 2014
Daty rejestracji na studia
Pierwszy przesłany
6 lutego 2014
Pierwszy przesłany, który spełnia kryteria kontroli jakości
10 lutego 2014
Pierwszy wysłany (Oszacować)
12 lutego 2014
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
11 grudnia 2017
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
8 listopada 2017
Ostatnia weryfikacja
1 czerwca 2015
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- CV-13-47
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
produkt wyprodukowany i wyeksportowany z USA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
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