Clinical Performance of Three Daily Disposable Silicone Hydrogel Contact Lenses (NCT06778057) | Clinical Trial Compass
CompletedNot Applicable
Clinical Performance of Three Daily Disposable Silicone Hydrogel Contact Lenses
United Kingdom22 participantsStarted 2024-12-29
Plain-language summary
This is a subject-masked, randomized, prospective, bilateral, 3x3 crossover dispensing clinical investigation to assess the clinical performance of a new lens type comparison.
Who can participate
Age range18 Years – 40 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 40 (inclusive) years of age at the time of screening.
4. By self-report, they typically use digital devices for a minimum of 4 hours per day, 5 days per week.
5. In a pre-study screening assessment, they must have a CVS-Q score of 6 or greater.
6. Agree not to participate in other clinical research while enrolled on this study.
7. Own a wearable pair of spectacles, if needed, for distance vision correction (by self-report).
8. By self-report, habitually wear 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 8 hours of wear per day, for at least 4 days per week over the past 4 weeks.
9. Attain a best-corrected logMAR distance visual acuity of at least 0.20 in each eye.
10. Have spherical contact lens prescription in the range -1.00 to -6.00 DS (based on the calculated ocular refraction) in each eye.
11. Have up to a maximum of 1.00 DC of refractive astigmatism (based on the calculated ocular refraction) in each eye.
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
1. Be current…
What they're measuring
1
Lens Fit Acceptance
Timeframe: Follow-up assessments will be made approximately 8-10 hours after lens dispensing