Clinical Evaluation of Two Cosmetic Contact Lenses (NCT06864858) | Clinical Trial Compass
CompletedNot Applicable
Clinical Evaluation of Two Cosmetic Contact Lenses
United States53 participantsStarted 2025-03-30
Plain-language summary
This is a single visit, single-masked, non-dispensing, randomized, controlled, 2×2 bilateral 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. Be a current soft contact lens wearer in both eyes with a minimum of 6 hours/day and 5 days/week over the last 30 days by self-report.
5. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 D to -6.00 D (inclusive) in each eye.
6. The subject's refractive cylinder must be less than or equal to 0.75 D (inclusive) in each eye.
7. Have spherical best corrected 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:
1. Be currently pregnant or lactating.
2. Have any systemic disease (eg, Sjögren's Syndrome), allergies, infectious disease (eg, hepatitis, tuberculosis), contagious immunosuppressive diseases (eg, HIV), autoimmune disease (eg rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study (at the investigator's discretion).
3. Use of systemic medications (eg, chronic steroid use) that are known to interfere with contact lens wear (at the investigator's discretion).
4. Have …
What they're measuring
1
Visual Acuity (logMAR)
Timeframe: After approximately 90-minute lens wear period