Evaluation of Delefilcon A and Senofilcon A Daily Disposable Toric Soft Contact Lenses Over One W… (NCT06749496) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Delefilcon A and Senofilcon A Daily Disposable Toric Soft Contact Lenses Over One Week of Wear
United States134 participantsStarted 2025-01-07
Plain-language summary
This is a prospective, multi-site, 4-visit, bilateral, dispensing, randomized, controlled, double-masked, 2x2 crossover study to evaluate subjective comfort, overall opinion and end of day comfort following wear of two different contact lenses.
Who can participate
Age range18 Years – 39 Years
SexALL
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Potential subjects must satisfy all of the following criteria to be enrolled in the study:
The subject must:
1. 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. Be between 18 and 39 (inclusive) years of age at the time of screening.
4. 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.
5. Possess a wearable pair of spectacles that provide correction for distance vision.
6. In both eyes, have refractive error suitable for correction with the range of toric contact lens powers available in this study:
6.1 Sphere powers (DS) -1.50 through -4.00 (inclusive) in 0.25 steps 6.2 Cylinder powers (DC) -0.75 and -1.25 6.3 Axes (°) 170, 180, 10, 80, 90 and 100
7. Have best corrected monocular distance visual acuity of 20/25 or better in each eye.
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
The subject must not:
1. Be currently pregnant or lactating.
2. Be diabetic.
3. Be currently using any ocular medications or have any ocular infection of any type.
4. By self-report, have any ocular or systemic disease, allergies, infection, or use of…