Clinical trial NCT03440242: Biomarker Discovery in Two Daily Disposable Contact Lenses
Official title: Biomarker Discovery in Two Daily Disposable Contact Lenses
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Visual Acuity
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2018-02-22
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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).

Primary outcomes:
measure: Summary of Protein (Lysozyme) in Tears
timeFrame: Approximately 2 hours duration of assessment time
Secondary outcomes:
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Narayana Nethralaya Foundation
city: Chennai
country: India
facility: Medical Research Foundation
Study officials:
References: