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Design Validation of Senofilcon A With New UV-blocking Additive

15 november 2019 uppdaterad av: Johnson & Johnson Vision Care, Inc.
This is a 2-visit, multi-site, partially subject-masked, 2-arm parallel, controlled, randomized and dispensing trial. Subjects will be randomized to one of two study lenses for the entire duration of the study. The study lenses will be worn for a period of 2 weeks each in a bilateral fashion.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

253

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • California
      • Cupertino, California, Förenta staterna, 95014
        • James T. Fujimoto, OD
    • Florida
      • Maitland, Florida, Förenta staterna, 32751
        • Maitland Vision Center
      • Tallahassee, Florida, Förenta staterna, 32308
        • Tallahassee Eye Center
    • Illinois
      • Bloomington, Illinois, Förenta staterna, 61701
        • Eyecare Associates LLP
    • Kansas
      • Pittsburg, Kansas, Förenta staterna, 66762
        • Kannarr Eye Care
    • Ohio
      • Granville, Ohio, Förenta staterna, 43023
        • Procare Vision Centers
      • Westerville, Ohio, Förenta staterna, 43081
        • Professional Vision Care, Inc
    • Tennessee
      • Memphis, Tennessee, Förenta staterna, 38111
        • Bradley Hines, OD
    • Texas
      • Tyler, Texas, Förenta staterna, 75703
        • Frazier Vision, Inc
    • Wisconsin
      • New Berlin, Wisconsin, Förenta staterna, 53151
        • Ziegler Leffingwell Eyecare

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 49 år (Vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Potential subjects must satisfy all of the following criteria to be enrolled in the study:

    1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
    2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
    3. Between 18 and 49 (inclusive) years of age at the time of informed consent.
    4. Eligible presbyopes will be those that wear full distance contact lenses in both eyes, then wear reading glasses over them when needed for near vision.
    5. The subject is a current spherical soft contact lens wearer in both eyes with a minimum of 6 hours/day and 5 days/week wear time over the last 30 days by self-report.
    6. Subjects must be able and willing to wear the study lenses at least 6 hours a day, a minimum of 5 days per week.
    7. Subjects must own a wearable pair of distance spectacles.
    8. The subject's vertex-corrected spherical equivalent distance refraction must be in the range of -1.00 to -6.00 D (inclusive) in each eye.
    9. The subject's refractive cylinder must be 0.00 to -1.00 D (inclusive) in each eye.

    10. The subject must have a spherocylindrical best corrected distance Snellen visual acuity of 20/25+3 or better in each eye.

      Exclusion Criteria:

  • Potential subjects who meet any of the following criteria will be excluded from participating in the study:

    1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
    2. Any active or ongoing systemic disease (e.g., Sjögren's Syndrome), infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis).
    3. Subjects taking suspect oral medications for less than one year.
    4. Any prescribed or over the counter (OTC) ocular medication.
    5. Any known hypersensitivity or allergic reaction to Optifree® PureMoist® multi-purpose care solution or Eye-Cept® rewetting drop solution.
    6. Toric, extended wear, monovision or multi-focal contact lens correction.
    7. Any previous or planned (during the course of the study) ocular surgery (e.g., PRK, LASIK, etc.).
    8. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
    9. Participation in clinical trials involving the Test lens within 3 months prior to study enrollment.
    10. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
    11. Binocular vision abnormality or strabismus by self-report or prior medical history.
    12. History of recurrent corneal erosions, herpetic keratitis, or pathological dry eye.
    13. Any active ocular allergies, infections or other ocular abnormalities (entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma) that the investigator determines may interfere with the outcomes of this study or otherwise contraindicate participation in the study.
    14. Any Grade 2 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA Slit Lamp Classification Scale.
    15. Any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar) within the past 3 years of otherwise successful contact lens wear.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: senofilcon A TEST Lens
Subjects between 18 to 49 years of age that are habitual wearers of spherical soft contact lenses will be randomized into the TEST Lens for the duration of the clinical study.
Enhet: senofilcon A TEST Lens
JJVC Investigational Contact Lens
Aktiv komparator: senofilcon A CONTROL Lens
Subjects between 18 to 49 years of age that are habitual wearers of spherical soft contact lenses will be randomized into the CONTROL Lens for the duration of the clinical study.
Enhet: senofilcon A CONTROL Lens
Acuvue Oasys

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Overall Comfort Score
Tidsram: 2-Week Follow-up Evlauation
Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patientexperience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
2-Week Follow-up Evlauation
Vision Satisfaction in Bright Lighting
Tidsram: 2-Week Follow-up Evaluation
Vision satisfaction in bright light was assessed using the individual item" I was satisfied with the quality of my vision in bright lighting" from the CLUE™ questionnaire. This item used the response scale, 1: Strongly Disagree, 2: Disagree, 3: Neither Agree nor Disagree, 4: Agree and 5: Strongly Agree. CLUE is the Contact Lens User Experience™ questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. The Proportion of responses in each category were reported for each lens type.
2-Week Follow-up Evaluation
Distance Visual Acuity
Tidsram: 2-Week Follow-up Evlauation
Distance visual acuity was assessed by eye using LogMAR visual acuity at 4 meters using an ETDRS chart under high illumination high contrast conditions (room illumination > 400 lux and chart luminance 120-200 cd/m2) at the 2-week follow-up for each subject eye. Lower values of logMAR indicate better vision, where a score of 0.0 equates to 20/20 snellen vision. The average visual acuity for each lens was reported.
2-Week Follow-up Evlauation
Contact Lens Fitting Acceptance Rate
Tidsram: Up to 2-Week Follow-up

Acceptable lens fit will be assessed at all study visits (scheduled and unscheduled) for each subject eye. Fit acceptance rate will be based on the lens fit acceptance of eyes wearing the Test lens only. Fit acceptance is a binary response where Y=1 if lens fit is acceptable and Y=0 otherwise. Unacceptable is defined as unacceptable if any one of the following criteria:

  • limbal exposure at primary gaze or with extreme eye movement;
  • edge lift;
  • excessive movement in primary up gaze;
  • insufficient movement in all three of the following conditions: primary gaze, up gaze, and push up test.

Eyes with multiple unacceptable fitting events will be counted only once. Fit rates of the Control lens will also be collected but are not a primary endpoint.
Up to 2-Week Follow-up
Number of Grade 3 or Higher Slit Lamp Findings
Tidsram: Up to 2-Week Follow-up Evlauation
Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). Slit Lamp Findings will be assessed for each subject eye at all study visits (schedule and unscheduled). SLF is a binary response where Y=1 for at least one Grade 3 or 4 slit lamp finding. The percentage of eyes with Grade 3 or higher slit lamp findings will be analyzed and will include corneal infiltrates. Eyes with multiple events will be counted only once. The number of eyes with SLF with grade 3 or higher by lens was reported.
Up to 2-Week Follow-up Evlauation

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Overall Handling Score
Tidsram: 2-Week Follow-up Evlauation
Overall handling was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patientexperience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
2-Week Follow-up Evlauation
Overall Quality of Vision Score
Tidsram: 2-Week Follow-up Evlauation
Overall quality of vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patientexperience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
2-Week Follow-up Evlauation

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Johnson & Johnson Vision Care, Inc.

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 oktober 2018

Primärt slutförande (Faktisk)

1 november 2018

Avslutad studie (Faktisk)

1 november 2018

Studieregistreringsdatum

Först inskickad

12 oktober 2018

Först inskickad som uppfyllde QC-kriterierna

12 oktober 2018

Första postat (Faktisk)

16 oktober 2018

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

5 december 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

15 november 2019

Senast verifierad

1 november 2019

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • CR-6305

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

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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