CompletedNot Applicable

Evaluation of Lens Rotation in Habitual Wearers of Toric, Soft Contact Lenses

United Kingdom6 participantsStarted 2024-12-06

Plain-language summary

This will be a single site, 2-visit, randomized, controlled, single-masked, non-dispensing, bilateral wear, 2x2 cross over study to assess visual acuity.

Who can participate

Age range18 Years – 39 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 39 years of age (inclusive) at the time of screening.
✓. Habitually wear soft, toric contact lenses in both eyes in a daily or daily disposable wear modality (i.e. not extended wear modality). Habitual wearer is defined as a minimum of 6 hours per day, for a minimum of 2 days per week during the past 30 days.
✓. Possess a wearable pair of spectacles that provide correction for distance vision (if applicable).
✓. Have the spherical component of their vertex-corrected distance refraction within the range +4.00 to -6.00 DS (inclusive) in both eyes.
✓. Have the magnitude of the cylindrical component of their vertex-corrected distance refraction between 0.75 DC and 2.50 DC in both eyes.
✓. Have best corrected monocular distance visual acuity of 0.2 or better in each eye.

Exclusion criteria

✕. Be currently pregnant or lactating.
✕. Be diabetic.
✕. 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 that 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.
✕. Be currently wearing or have had worn Acuvue® Oasys 1-Day for Astigmatism, or Dailies® Total1 for Astigmatism lenses during the last 3 months.

What they're measuring

Distance Monocular Visual Acuity (LogMAR)

Timeframe: Approximately 15-minutes Post Lens Insertion

Trial details

NCT IDNCT06649019

SponsorJohnson & Johnson Vision Care, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-16

Results submitted2025-12-16

View on ClinicalTrials.gov More Visual Acuity trials