CompletedNot Applicable

Role of Glare and Spectral Filtering on Contrast Sensitivity: A Pilot Study

United States40 participantsStarted 2022-10-31

Plain-language summary

This will be a split-plot design, randomized, parallel, double-masked feasibility study to evaluate the role of a test lens on contrast sensitivity with and without glare.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. 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.
✓. Be between 18 and 65 (inclusive) years of age at the time of screening.
✓. By self-report, habitually wear spherical silicone hydrogel soft contact lenses in both eyes in a daily reusable or daily disposable wear modality (i.e. not extended wear modality). Habitual wear is defined as a minimum of 6 hours of wear per day, for a minimum of 5 days per week during the past 30 days.
✓. Possess a wearable pair of spectacles that provide correction for distance vision.
✓. The spherical equivalent of the subject's vertex corrected distance refraction must be between -1.00 D and -6.00 D (inclusive) in each eye.
✓. The magnitude of the cylindrical component of the subject's vertex-corrected distance refraction must be between 0.00 D and 1.00 D (inclusive) in each eye.
✓. The best corrected, monocular, distance visual acuity must be 20/25 or better in each eye.

Exclusion criteria

✕. Be currently pregnant or lactating.
✕. Be currently using any ocular medications or have any ocular infection of any type.
✕. By self-report, have any ocular or systemic disease, allergies, infection, or use of medication the investigator believes might contraindicate or interfere with contact lens wear, or otherwise compromise study endpoints, including infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus \[HIV\]), autoimmune disease (e.g. rheumatoid arthritis, Sjögren's syndrome), or history of serious mental illness or seizures. See section 9.1 for additional details regarding excluded systemic medications.
✕. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months.
✕. Be currently wearing monovision or multifocal contact lenses.
✕. Be currently wearing lenses in an extended wear modality.
✕. Have participated in a contact lens or lens care product clinical trial within 30 days prior to study enrollment.
✕. Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site.

What they're measuring

Area Under the Curve of Photopic Contrast Sensitivity Function Under Bright Light Conditions (∼120 cd/m2) With a Broadband Glare Source

Timeframe: Up to 2 hours post-fitting

Trial details

NCT IDNCT05582304

SponsorJohnson & Johnson Vision Care, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-12-08

Results submitted2023-11-20

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