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- Klinische proef NCT01791517
Clinical and Laboratory Evaluation of 3 Contact Lenses With 4 Contact Lens Solutions
18 juni 2018 bijgewerkt door: Johnson & Johnson Vision Care, Inc.
Clinical and Laboratory Evaluation of Three Contact Lens Materials With Four Contact Lens Solutions
The purpose of this study is to evaluate the clinical and laboratory performance of three brand name contact lenses with three recently introduced multipurpose lens care solutions (test solutions) as well as a peroxide disinfecting solution (control solution).
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
269
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Ontario
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Waterloo, Ontario, Canada
- University of Waterloo Centre for Contact Lens Research School of Optometry
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Lancashire
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Manchester, Lancashire, Verenigd Koninkrijk
- University of Manchester, Department of Optometry & Neuroscience
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Texas
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Houston, Texas, Verenigde Staten, 77204
- University of Houston College of Optometry
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 69 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
- The subject must appear able and willing to adhere to the instruction set forth in this clinical protocol.
- The subject must be between 18 and 69 years of age.
- The subject must be willing to participate in a 9-month study.
- The subject must require a visual correction in both eyes.
- Subjective refraction must result in a vertex-corrected spherical contact lens prescription of +2.00D to -8.00D in each eye.
- The subject must have best-corrected visual acuity of 0.20 or better in each eye.
- The subject must be a current wearer of spherical soft contact lenses (no bifocal contact lenses or monovision) for at least 5 days/week and at least 8 hours/day during the month prior to enrollment.
- The subject must require no more than -1.25D cylindrical correction in each eye after vertexing to the corneal plane.
- The subject must have normal eye with no evidence of abnormality or disease that in the opinion of the investigator would contraindicate contact lens wear.
Exclusion Criteria:
- Self-reported current pregnancy or lactation or plans to become pregnant during the study period (subjects who report becoming pregnant during the study will be discontinued).
- Self-reported adverse reaction to a contact lens solution to be used in the study that in the opinion of the investigator would contraindicate use of that solution.
- Any previous ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.).
- Any clinically meaningful slit lamp findings contraindicating contact lens wear (e.g. equal to or greater than Grade 3 finding of edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection, blepharitis/meibomian gland dysfunction) on the study specific classification scale or any other ocular abnormality that in the opinion of the investigator would contraindicate contact lens wear.
- Any active ocular infection.
- Current use of topical ophthalmic medications.
- History of binocular vision abnormality or strabismus.
- More than occasional use of dry eye/rewetting drops (more than 2 times per day on average).
- Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV) by self-report.
- History of severe allergic reaction or anaphylaxis.
- Other active ocular disease that in the opinion of the investigator would contraindicate contact lens wear.
- Employee of the investigational clinic (e.g. investigator, coordinator, technician)
- They have taken part in any other clinical trial or research, within two weeks prior to starting this study.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Ander: Lens A (senofilcon A)
Subjects randomized to Lens A will be further randomized to 1 of 12 unique solution sequences; each subject will receive all four study solutions in a random order (Solution 1(Test), Solution 2(Test), Solution 3(Test), Solution 4(Control)).
|
Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to all four lens care solution in a random order
Andere namen:
Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order
Andere namen:
Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order
Andere namen:
Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order
Andere namen:
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Ander: Lens B (galyfilcon A)
Subjects randomized to Lens B will be further randomized to 1 of 12 unique solution sequences; each subject will receive all four study solutions in a random order (Solution 1(Test), Solution 2(Test), Solution 3(Test), Solution 4(Control)).
|
Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to all four lens care solution in a random order
Andere namen:
Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order
Andere namen:
Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order
Andere namen:
Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order
Andere namen:
|
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Ander: Lens C (etafilcon A)
Subjects randomized to Lens C will be further randomized to 1 of 12 unique solution sequences; each subject will l receive all four study solutions in a random order (Solution 1(Test), Solution 2(Test), Solution 3(Test), Solution 4(Control)).
|
Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to all four lens care solution in a random order
Andere namen:
Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order
Andere namen:
Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order
Andere namen:
Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Overall Comfort Score (Senofilcon A Lens)
Tijdsspanne: 2-Week Follow-up
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CLUE overall comfort is assessed using the Contact Lens User Experience (CLUE)TM questionnaire for the senofilcon A lens only.
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 +/-3XSD).
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2-Week Follow-up
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Overall Comfort Score (Galyfilcon A Lens)
Tijdsspanne: 2-Week Follow-up
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CLUE overall comfort is assessed using the Contact Lens User Experience (CLUE)TM questionnaire for the galyfilcon A lens only.
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 +/-3XSD).
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2-Week Follow-up
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Overall Comfort Score (Etafilcon A Lens)
Tijdsspanne: 2-Week Follow-up
|
CLUE overall comfort is assessed using the Contact Lens User Experience (CLUE)TM questionnaire for the etafilcon A lens only.
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 +/-3XSD).
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2-Week Follow-up
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- Schulze MM, Srinivasan S, Hickson-Curran SB, Berntsen DA, Howarth GF, Toubouti Y, Morgan P, Nichols JJ, Jones LW; Performance of Contact Lens Solutions Study Group. Lid Wiper Epitheliopathy in Soft Contact Lens Wearers. Optom Vis Sci. 2016 Aug;93(8):943-54. doi: 10.1097/OPX.0000000000000919.
- Berntsen DA, Hickson-Curran SB, Jones LW, Mathew JH, Maldonado-Codina C, Morgan PB, Schulze MM, Nichols JJ; Performance of Contact Lens Solutions Study Group. Subjective Comfort and Physiology with Modern Contact Lens Care Products. Optom Vis Sci. 2016 Aug;93(8):809-19. doi: 10.1097/OPX.0000000000000901.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 februari 2013
Primaire voltooiing (Werkelijk)
1 februari 2014
Studie voltooiing (Werkelijk)
1 februari 2014
Studieregistratiedata
Eerst ingediend
11 februari 2013
Eerst ingediend dat voldeed aan de QC-criteria
11 februari 2013
Eerst geplaatst (Schatting)
15 februari 2013
Updates van studierecords
Laatste update geplaatst (Werkelijk)
19 juni 2018
Laatste update ingediend die voldeed aan QC-criteria
18 juni 2018
Laatst geverifieerd
1 oktober 2017
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CR-5230
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Ja
product vervaardigd in en geëxporteerd uit de V.S.
Ja
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .