Status:
COMPLETED
Non-Invasive Assessment of Contact Lens Performance During Use of a Digital Display
Lead Sponsor:
Johnson & Johnson Vision Care, Inc.
Conditions:
Visual Acuity
Eligibility:
All Genders
18-40 years
Phase:
NA
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 as...
Eligibility Criteria
Inclusion
- 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.
- Between 18 and 35 (inclusive) years of age at the time of screening.
- They agree not to participate in other clinical research while enrolled on this study.
- 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.
- They own a wearable pair of spectacles if needed for distance vision correction (by self-report).
- They typically use digital devices for a minimum of 4 hours per day, 5 days per week.
- 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).
- They can attain a best-corrected logMAR distance visual acuity of at least 0.20 in each eye.
- They have spherical contact lens prescription in the range +1.00 to -6.00 DS (based on the calculated ocular refraction).
- They have up to maximum of 0.75 DC of refractive astigmatism (based on the calculated ocular refraction).
Exclusion
- Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- Currently pregnant or lactating.
- 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.
- They have an ocular disorder which would normally contraindicate contact lens wear.
- They have had cataract surgery.
- They have had corneal refractive surgery.
- They are regularly (once per day or more) using oral or inhaled steroids or anti-inflammatory medications.
- They are using any topical medications such as eye drops or ointments.
- Any known hypersensitivity or allergic reaction to sodium fluorescein.
- 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.
- Participation in any contact lens or lens care product clinical trial within 2 weeks prior to study enrollment.
- Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
- They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
- 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.
- 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.
Key Trial Info
Start Date :
May 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2022
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT04869189
Start Date
May 10 2021
End Date
June 28 2022
Last Update
July 21 2023
Active Locations (1)
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1
The University of Manchester
Manchester, United Kingdom, M13 9PL