Evaluation of Approved Contact Lenses (NCT07174596) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Approved Contact Lenses
United States85 participantsStarted 2025-09-11
Plain-language summary
This is a prospective, randomized, controlled, subject-masked, bilateral, dispensing, multi-site, 2 lenses × 3 wearing periods crossover study to evaluate visual acuity.
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: 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 spherical soft silicone hydrogel 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.
5\. Have a habitual contact lens prescription that is current (no power change needed) within the prior 6 months, and they must have worn that prescription for at least 2 weeks prior to entering the study.
6\. Possess a wearable pair of spectacles that provide correction for distance vision.
7\. The spherical equivalent of the subject's vertex-corrected distance refraction must be between -1.00 D and -6.00 D in each eye.
8\. The best corrected, monocular, distance visual acuity must be 20/25 or better in each eye.
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
1. Be currently pregnant or lactating.
2. Be currently using any ocular medications or have any ocular infection of any type.
3. By self-report, have any ocular or systemic disease, …
What they're measuring
1
Proportion of Eyes Achieving 20/20 Distance Monocular Snellen VA or Better at the 1-week follow-up visit