Health Condition 1: null- Subjects wearing their own habitual lenses which can either be 1-DAY ACUVUE® MOIST (1DAM) or DAILIES® Aqua Comfort PLUS (DACP)
Conditions
Interventions
Intervention1: Not applicable: Not applicable
Control Intervention1: Not applicable: Not applicable
Sponsors
Johnson and Johnson Vision Care Inc
Eligibility
Inclusion criteria
Inclusion criteria: 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 a 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 . Subjects must meet one of the following criteria in order to be classified as either asymptomatic or symptomatic group: a. Asymptomatic group: CLDEQ-8 score of b. 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 unaided binocular visual acuity of 20/40 or better.
Exclusion criteria
Exclusion criteria: Currently pregnant or lactating 2. Any diseases (e.g., Sjögrenâ??s Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), diabetes, 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, immunosuppressants 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 styles, 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, 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 within the past 6 months 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Descriptive summary of biomarker interleukin-6 (IL-6)Timepoint: 01 day lens wear | — |
Secondary
| Measure | Time frame |
|---|---|
| Not applicableTimepoint: Not applicable | — |
Countries
India
Contacts
Public ContactDr Shariq Anwar
JSS Medical Research India Private Limited
Outcome results
None listed