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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JJVC Contact Lens | Device | etafilcon A with PVP DD |
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| Measure | Description | Time Frame |
|---|---|---|
| Summary of Protein (Lysozyme) in Tears | 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. | Approximately 2 hours duration of assessment time |
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Inclusion Criteria:
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
Appear able and willing to adhere to the instructions set forth in this clinical protocol.
Appear able and willing to adhere to a no lens wear period of at least one month.
Between 18 and 45 (inclusive) years of age at the time of screening.
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.
Subject must have visual acuity of at least 20/40 or better in each eye with their habitual lenses
Subjects must meet one of the following criteria in order to be classified as either asymptomatic or symptomatic group:
Have healthy eyes with no evidence of abnormality or disease (i.e., no active ocular pathological conditions/ infections of any type).
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:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Narayana Nethralaya Foundation | Bangalore | India | ||||
| Medical Research Foundation |
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| Marketed Contact Lens | Device | nelfilcon A DD |
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| Chennai |
| India |