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 range
40 Years – 70 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)