Silicone Hydrogel Contact Lenses on Low Astigmatism in Japan (NCT00639353) | Clinical Trial Compass
TerminatedNot Applicable
Silicone Hydrogel Contact Lenses on Low Astigmatism in Japan
Stopped: English to Japanese translation issues caused enrollment of incorrect and unqualified subjects; error applied to all subjects enrolled prior to termination.
Japan102 participantsStarted 2008-02
Plain-language summary
This study seeks to evaluate the clinical performance of a recently released contact lens designed to correct astigmatism to an established contact lens that has historically been used in these patients.
Who can participate
Age range
18 Years – 39 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 is 18 to 39 years of age. (Parental consent is required for a minor child i.e. under the age of 20.)
. The subject has signed an informed consent with his/her own judgement for participation in the study.
. The subject currently is a habitual wearer of spherical or toric daily-wear soft contact lenses, excluding daily disposables, in daily wear bases.
Exclusion criteria
. The subject has any ocular or systemic allergies that interfere with contact lens wear.
. The subject has dry eye and lacrimal apparatus disease that could interfere with contact lens wear.
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 has any systemic disease or autoimmune disease that interferes with contact lens wear.
. The subject has corneal edema, neovascularization, corneal staining or other ocular abnormalities (Grade 3 or above) that clinically apparently interfere with contact lens wear.
. The subject has any anterior segment eye disease (palpebral abnormalities, corneal hypesthesia, corneal epithelial defect, bulbar conjunctival hyperemia, etc.) that clinically apparently interferes with contact lens wear.
. The subject has a history of solution reactions to the chemical cleaner/disinfectant to be used in this study, as far as known to the subject.
. The subject has ocular infection.
. The subject has ocular inflammation (including acute/subacute anterior segment inflammations and uveitis).