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Biomarker Discovery in Two Daily Disposable Contact Lenses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03440242
Recruitment Status : Completed
First Posted : February 21, 2018
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

Brief Summary:
This is a non-masked, non-randomized, stratified, 4-arm parallel group, non-interventional study where subjects will be enrolled into one of four arms based on their habitual contact lenses. Subjects will be wearing their habitual contact lenses throughout the study and will be scheduled for morning and afternoon visits totaling 10 visits with a ~4-week washout period between visits 6 and 7.

Condition or disease Intervention/treatment
Visual Acuity Device: JJVC Contact Lens Device: Marketed Contact Lens

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Study Type : Observational
Actual Enrollment : 43 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biomarker Discovery in Two Daily Disposable Contact Lenses
Actual Study Start Date : January 9, 2018
Actual Primary Completion Date : October 12, 2018
Actual Study Completion Date : October 12, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Group/Cohort Intervention/treatment
JJVC Contact Lens (Asymptomatic)
Subjects between the ages of 18 and 45 years of age will be enrolled to the JJVC Contact Lens arm based on their habitual lenses and then stratified to an Asymptomatic group based on wear time responses during the baseline assessment.
Device: JJVC Contact Lens
etafilcon A with PVP DD

JJVC Contact Lens (Symptomatic)
Subjects between the ages of 18 and 45 years of age will be enrolled to the JJVC Contact Lens arm based on their habitual lenses and then stratified to a Symptomatic group based on wear time responses during the baseline assessment.
Device: JJVC Contact Lens
etafilcon A with PVP DD

Marketed Contact Lens (Asymptomatic)
Subjects between the ages of 18 and 45 years of age will be enrolled to the Marketed Contact Lens arm based on their habitual lenses and then stratified to an Asymptomatic group based on wear time responses during the baseline assessment.
Device: Marketed Contact Lens
nelfilcon A DD

Marketed Contact Lens (Symptomatic)
Subjects between the ages of 18 and 45 years of age will be enrolled to the Marketed Contact Lens arm based on their habitual lenses and then stratified to a Symptomatic group based on wear time responses during the baseline assessment.
Device: Marketed Contact Lens
nelfilcon A DD




Primary Outcome Measures :
  1. Summary of Protein (Lysozyme) in Tears [ Time Frame: Approximately 2 hours duration of assessment time ]
    Summarizing potential differences in biomarker responses in tears of subjects wearing two different materials of daily disposable contact lenses. Lysozyme as biomarker in tears will be collected via Schirmer's strips and Capillary tubes at all scheduled visits and will be analyzed using Chromatography.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Study subjects will be recruited from the Institution/clinical site's subject database and/or utilizing Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved materials.
Criteria

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. Appear able and willing to adhere to a no lens wear period of at least one month.
    4. Between 18 and 45 (inclusive) years of age at the time of screening.
    5. Subject must be currently wearing one of the two habitual contact lenses in both eyes (1DAM or DACP) for at least three months. Habitual CL wear is defined as having a minimum wearing time of 3 hours per day, minimum of 3 days per week for at least 3 months.
    6. Subject must have visual acuity of at least 20/40 or better in each eye with their habitual lenses
    7. Subjects must meet one of the following criteria in order to be classified as either asymptomatic or symptomatic group:

      1. Asymptomatic group: CLDEQ-8 score of ≤7, difference between CWT and AWT <1 hours/day
      2. Symptomatic group: CLDEQ-8 score of ≥15, difference between CWT and AWT >3 hours/day
    8. Have healthy eyes with no evidence of abnormality or disease (i.e., no active ocular pathological conditions/ infections of any type).
    9. Have a pair of spectacles that provide corrected binocular visual acuity of 20/40 or better. If no spectacles, subjects must have un-aided binocular visual acuity of 20/40 or better.

      Exclusion Criteria:

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

    1. Currently pregnant or lactating
    2. Any systemic disease (e.g., Sjögren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study.
    3. Unacceptable lens fit with their habitual lenses in either eye based on study investigators judgment.
    4. Any extended wear modality.
    5. Use of systemic medications (e.g., chronic steroid use, immuno-suppressants or anti-infective medications) that are known to interfere with contact lens wear.
    6. Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion.
    7. Any previous, or planned (during the course of the study) intraocular/refractive surgery.
    8. Any Grade 3 or 4 slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, and conjunctival injection) on the FDA scale.
    9. Any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that would contraindicate contact lens wear.
    10. Participation in any interventional contact lens, eye drop or lens care product clinical trial within 30 days prior to study enrollment.
    11. Suspicion of or recent history of alcohol or substance abuse, serious mental illness, or seizures.
    12. Employee of clinical site (e.g., Investigator, Coordinator, Technician).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03440242


Locations
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India
Narayana Nethralaya Foundation
Bangalore, India
Medical Research Foundation
Chennai, India
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.

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Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT03440242     History of Changes
Other Study ID Numbers: CR-5982
First Posted: February 21, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes