Clinical trial NCT04869189: Non-Invasive Assessment of Contact Lens Performance During Use of a Digital Display
Official title: Non-Invasive Assessment of Contact Lens Performance During Use of a Digital Display
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Acuity
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2021-05-03
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This is a two-arm, open-label, bilateral dispensing clinical investigation. Eligible subjects will proceed to either a low-sphere or high-sphere arm based on refraction measurements in the baseline assessment.


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. Between 18 and 35 (inclusive) years of age at the time of screening.
  4. They agree not to participate in other clinical research while enrolled on this study.
  5. They have worn the same brand of soft contact lenses at least eight hours per day for at least two days per week over the previous three months.
  6. They own a wearable pair of spectacles if needed for distance vision correction (by self-report).
  7. They typically use digital devices for a minimum of 4 hours per day, 5 days per week.
  8. In a pre-study screening assessment, they must have a CVS-Q score of 4 or less (asymptomatic group) or 6 or greater (symptomatic group).
  9. They can attain a best-corrected logMAR distance visual acuity of at least 0.20 in each eye.
  10. They have spherical contact lens prescription in the range +1.00 to -6.00 DS (based on the calculated ocular refraction).
  11. They have up to maximum of 0.75 DC of refractive astigmatism (based on the calculated ocular refraction).

      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. They have an ocular disorder which would normally contraindicate contact lens wear.
  4. They have had cataract surgery.
  5. They have had corneal refractive surgery.
  6. They are regularly (once per day or more) using oral or inhaled steroids or anti-inflammatory medications.
  7. They are using any topical medications such as eye drops or ointments.
  8. Any known hypersensitivity or allergic reaction to sodium fluorescein.
  9. Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear. See section 9.1 for additional details regarding excluded systemic medications.
  10. Participation in any contact lens or lens care product clinical trial within 2 weeks prior to study enrollment.
  11. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
  12. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
  13. They have any existing binocular vision anomalies such as strabismus or have been prescribed prisms in their spectacles based on self-report, or in the opinion of the investigator exhibit signs of suppression during binocular vision testing.
  14. Any Efron Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) which in the investigator's opinion would contraindicate contact lens wear.

Primary outcomes:
measure: Visual Analogue Scales (VAS)
timeFrame: at approximately 2-week follow-up
measure: Tear film surface quality
timeFrame: at approximately 2-week follow-up
measure: Tear meniscus height
timeFrame: at approximately 2-week follow-up
measure: Blink frequency
timeFrame: at approximately 2-week follow-up
measure: Interblink interval
timeFrame: at approximately 2-week follow-up
measure: Blink completeness
timeFrame: at approximately 2-week follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: The University of Manchester
Study officials:
affiliation: Johnson & Johnson Vision Care, Inc.
name: Johnson & Johnson Vision Care, Inc. Clinical Trial
role: STUDY_DIRECTOR
References: