CompletedNot Applicable

Evaluation of Delefilcon A and Senofilcon A Daily Disposable Toric Soft Contact Lenses Over Two Weeks of Wear

United States67 participantsStarted 2023-11-16

Plain-language summary

This will be a multi-site, bilateral, dispensing, randomized, controlled, double-masked, 2×2 crossover study to evaluate ocular physiological response.

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 (inclusive) years of age at the time of screening.
✓. By self-report, habitually wear 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 2 days per week during the past four weeks.
✓. Possess a wearable pair of spectacles that provide correction for distance vision.
✓. In both eyes, have refractive error suitable for correction with the toric contact lens powers available in this study:
✓. Sphere powers (DS) -1.50 through -4.00 in 0.25 steps
✓. Cylinder powers (DC) -0.75 and -1.25

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.
✕. Have a history of strabismus or amblyopia.

What they're measuring

Proportion of Eyes With Grade 3 or Higher Slit Lamp Findings

Timeframe: Up to 2-Week Follow-up

Trial details

NCT IDNCT06161012

SponsorJohnson & Johnson Vision Care, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-02-13

Results submitted2025-02-05

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