- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01791517
Clinical and Laboratory Evaluation of 3 Contact Lenses With 4 Contact Lens Solutions
18 juni 2018 uppdaterad av: 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).
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
269
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Texas
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Houston, Texas, Förenta staterna, 77204
- University of Houston College of Optometry
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Ontario
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Waterloo, Ontario, Kanada
- University of Waterloo Centre for Contact Lens Research School of Optometry
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Lancashire
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Manchester, Lancashire, Storbritannien
- University of Manchester, Department of Optometry & Neuroscience
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 69 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Övrig: 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
Andra namn:
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
Andra namn:
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
Andra namn:
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
Andra namn:
|
Övrig: 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
Andra namn:
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
Andra namn:
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
Andra namn:
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
Andra namn:
|
Övrig: 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
Andra namn:
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
Andra namn:
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
Andra namn:
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
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Overall Comfort Score (Senofilcon A Lens)
Tidsram: 2-Week Follow-up
|
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)
Tidsram: 2-Week Follow-up
|
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).
|
2-Week Follow-up
|
Overall Comfort Score (Etafilcon A Lens)
Tidsram: 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).
|
2-Week Follow-up
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 februari 2013
Primärt slutförande (Faktisk)
1 februari 2014
Avslutad studie (Faktisk)
1 februari 2014
Studieregistreringsdatum
Först inskickad
11 februari 2013
Först inskickad som uppfyllde QC-kriterierna
11 februari 2013
Första postat (Uppskatta)
15 februari 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
19 juni 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
18 juni 2018
Senast verifierad
1 oktober 2017
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CR-5230
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Ja
produkt tillverkad i och exporterad från U.S.A.
Ja
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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