Pilot Evaluation of a New Galyfilcon A Contact Lens Compared to a Marketed Galyfilcon A Contact Lens
18. juni 2018 opdateret af: Johnson & Johnson Vision Care, Inc.
A Multi-site Dispensing Evaluation Comparing a New Galyfilcon A Prototype Lens With a Marketed Galyfilcon A Contact Lens
The purpose of this study is to compare lens surface characteristics and comfort between an experimental contact lens and a marketed contact lens.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
185
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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California
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Cupertino, California, Forenede Stater
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Huntington Beach, California, Forenede Stater
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Los Angeles, California, Forenede Stater
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Pismo Beach, California, Forenede Stater
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Florida
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Jacksonville, Florida, Forenede Stater
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Orlando, Florida, Forenede Stater
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Michigan
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East Lansing, Michigan, Forenede Stater
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Ohio
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Columbus, Ohio, Forenede Stater
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Texas
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Amarillo, Texas, Forenede Stater
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 39 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- The subject must be at least 18 years of age and no more than 39 years of age.
- The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of daily wear (DW) for a minimum of 1 month prior to the study) and willing to wear the study lenses on a daily wear basis (defined as a minimum of 6 hours of wear per day at least five days of the week) for the duration of the study.
- The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 9.00D.
- Any cylinder power must be ≤ -0.75D.
- The subject must have visual acuity best correctable to 20/25+3 or better for each eye.
- The subject must read and sign the Statement of Informed Consent.
- The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
Exclusion Criteria:
- Ocular or systemic allergies or disease which might interfere with contact lens wear.
- Systemic disease or use of medication which might interfere with contact lens wear.
- Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
- Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
- Any ocular infection.
- Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
- Pregnancy or lactation.
- Diabetes.
- Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
- Habitual contact lens type is toric, multifocal, or is worn as extended wear.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: galyfilcon A prototype/marketed galyfilcon A
The galyfilcon A prototype lens worn daily for 12-16 days during the first period then the marketed galyfilcon A lens worn daily for 12-16 days during the second period.
|
Experimental silicone hydrogel contact lens
Marketed silicone hydrogel contact lens.
Andre navne:
|
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Andet: marketed galyfilcon A/galyfilcon A prototype
The marketed galyfilcon A lens worn daily for 12-16 days during the first period then the galyfilcon A prototype lens worn daily for 12-16 days during the second period; during each period.
|
Experimental silicone hydrogel contact lens
Marketed silicone hydrogel contact lens.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Lens Front Surface Deposits at Day 7
Tidsramme: Evaluated at Day 7
|
Deposits on the front surface of each lens were examined by the investigator after 7 days of lens wear, and graded on a 5-point scale; 0 = no deposit, 1 = 1%-5% deposits, 2 = 6%-15% deposits, 3 = 16%-25% deposits, and 4 = 25% or more deposits.
The grades were categorized into binary variable: grade 0 or 1 Vs.
grade 2 or higher.
|
Evaluated at Day 7
|
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Lens Front Surface Deposits at Day 14
Tidsramme: Evaluated at Day 14
|
Deposits on the front surface of each lens were examined by the investigator after 14 days of lens wear, and graded on a 5-point scale; 0 = 0% deposits, 1 = 1%-5% deposits, 2 = 6%-15% deposits, 3=16%-25% deposits, and 4= 25% or more deposits.
The grades were categorized into binary variable: grade 0 or 1 vs. grade 2 or higher.
|
Evaluated at Day 14
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Subject Reported Overall Lens Comfort at Day 7
Tidsramme: Evaluated at Day 7
|
The overall lens comfort was assessed at Day 7 using the Contact Lens User Experience (CLUE) questionnaire.
CLUE is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging)in a contact lens wearing population in the US, ages 18-65.
Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable /positive response.
97% of the scores fall within 0 and 120 (mean +/-3*SD).
|
Evaluated at Day 7
|
|
Subject Reported Overall Lens Comfort at Day 14
Tidsramme: Evaluated at Day 14
|
The overall lens comfort was assessed at Day 14 using the CLUE questionnaire.
CLUE is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging)in a contact lens wearing population in the US, ages 18-65.
Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable /positive response.
97% of the scores fall within 0 and 120 (mean +/-3*SD).
|
Evaluated at Day 14
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. februar 2010
Primær færdiggørelse (Faktiske)
1. april 2010
Studieafslutning (Faktiske)
1. april 2010
Datoer for studieregistrering
Først indsendt
24. marts 2010
Først indsendt, der opfyldte QC-kriterier
26. marts 2010
Først opslået (Skøn)
29. marts 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
19. juni 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. juni 2018
Sidst verificeret
1. august 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CR-1636AY
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .