Pilot Dispensing Study of Two Marketed Daily Disposable Multifocal Contact Lenses (NCT07076160) | Clinical Trial Compass
CompletedNot Applicable
Pilot Dispensing Study of Two Marketed Daily Disposable Multifocal Contact Lenses
United States74 participantsStarted 2025-07-24
Plain-language summary
This is a 6-visit, single-masked, multi-site, 2×3 crossover, randomized-controlled, dispensing clinical trial to evaluate visual acuity.
Who can participate
Age range40 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 at least 40 years of age and not greater than 70 years of age at the time of consent.
4. Own a wearable pair of spectacles if required for their distance vision.
5. Be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 6 hours per wear day, for 30 days or more duration).
6. Either already be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, monovision or multifocal contact lenses, etc.) or if not respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire".
7. The subject's distance spherical equivalent refraction must be in the range of +1.00 to +4.00 or -1.00 D to -4.00 D in each eye.
8. The subject's refractive cylinder must be ≤0.75 D in each eye.
9. The subject's ADD power must be in the range of +0.75 D to +2.50 D.
10. The subject must have distance best corrected visual acuity of 20/20-3 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 active or ongoing ocular or systemic allergies that may interfere with contact len…
What they're measuring
1
High Luminance, High Contrast (HLHC) Binocular logMAR Visual Acuity at distance (4 meters)
Timeframe: 1-week follow-up
2
High Luminance, High Contrast (HLHC) Binocular logMAR Visual Acuity at intermediate (64 cm)
Timeframe: 1-week follow-up
3
High Luminance, High Contrast (HLHC) Binocular logMAR Visual Acuity at near (40 cm)