A Prospective, Randomized, Double-blind, Parallel, Active-controlled Clinical Study of Silicone H… (NCT06121531) | Clinical Trial Compass
CompletedNot Applicable
A Prospective, Randomized, Double-blind, Parallel, Active-controlled Clinical Study of Silicone Hydrogel Monthly Soft Contact Lens for the Safety and Effectiveness in Visual Correction.
Taiwan144 participantsStarted 2021-02-01
Plain-language summary
This was a prospective, randomized, double-blind, parallel, active-controlled clinical study to assess the safety and efficacy of Silicone Hydrogel Contact Lens for vision correction.
Who can participate
Age range
20 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
. 20 years old and above.
. Subjects with normal eyes who are not using any ocular medications (excluding ocular lubricants and artificial tears).
. Best spectacle corrected visual acuity greater than or equal to 1.0 for both eyes.
. With +6.00D \~ -12.00 D spherical power, and ≦1.00 D astigmatism (based on subjective optometry measurements).
. Have worn soft contact lens for at least 1 month prior to the study.
. Willing to comply with the required wearing time and use specified contact lens care product.
. Agree to comply with all study procedures and signed the informed consent form before enrollment.
Exclusion criteria
. Anterior chamber infection, inflammation, or abnormality.
. Any active ocular disease that would affect contact lens wear or vision (such as acute and subacute inflammation of the anterior chamber of the eye, eye infection, uveitis, serious palpebral abnormality, corneal hypoesthesia, corneal epithelium abrasion, dry eye and tear duct defection, ocular allergies, highly suspected glaucoma) upon evaluation by the investigators or slit lamp findings.
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.
. Currently using systemic or ocular medications that would contraindicate with contact lens wear (such as, glaucoma eye drops, steroid anti-inflammatory drops, eye ointments, eye gels and other eye medicines).
. History of herpes simplex keratitis.
. History of refractive surgery, keratoconus, or irregular cornea.
. Slit lamp findings that are not suitable for inclusion (Details of the grading standards for each eye condition are specified in CIP section 5.7.5 from page 38 to 43).
. A pathologically dry eye syndrome (Schirmer test \< 5 mm).
. Have participated in any contact lens or contact lens care product clinical trials within the previous 1 month (excluding questionnaire types and specimen collection).