Evaluation of A Marketed Silicone Hydrogel Spherical Lens Used for Monovision Correction of Presb… (NCT04073186) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of A Marketed Silicone Hydrogel Spherical Lens Used for Monovision Correction of Presbyopia
United States91 participantsStarted 2019-08-07
Plain-language summary
This is a single-masked, dispensing clinical trial. A total of approximately 48 myopic and 32 hyperopic eligible subjects will be targeted to complete the study. Subjects will be fit in the study lens, optimized if required and worn for approximately 2 weeks. Subjects will then have a washout period of approximately 1 week and be refit in the lenses and be dispensed for an additional 2 weeks of wear.
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.
Inclusion criteria
. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
. The subject must be between 40 and 70 years of age at the time of screening.
. Subjects must own a wearable pair of spectacles if required for their distance vision.
. The subject must be an adapted monovision soft contact lens wearer in both eyes (i.e., worn lenses a minimum of 2 days per week for at least 8 hours per wear day, for 1 month of more duration).
. The subject's distance spherical equivalent refraction must be in the range of +3.50 D to -4.00 D in each eye.
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.
. The subject's refractive cylinder must be ≤1.00 D in each eye.
. The subject's ADD power must be in the range of +0.75 D to +2.50 D.
Exclusion criteria
. Currently Pregnant or lactating.
. Any active or ongoing systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, diabetes, hyperthyroidism, recurrent herpes simplex/zoster, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g., hepatitis, tuberculosis).
. Use of any of the following medications within 1 week prior to enrollment: oral retinoid isotretinoin (e.g. Accutane), oral tetracyclines, oral phenothiazines (e.g., Haldol, Mellaril, Thorazine, Elavil, Pamelor, Compazine), systemic steroids.
. Any previous, or planned, ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, lid procedures, cataract surgery, retinal surgery, dacryocystorhinostomy, etc.).
. Use of any ocular medication, with the exception of rewetting drops.
. Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
. Any known hypersensitivity or allergic reaction to OPTI-FREE® Puremoist® care cleaning solution, non-preserved rewetting drop solution or sodium fluorescein.