A Clinical Trial to Evaluate the Vision Correction Safety and Efficacy of MSiHy Silicone Hydrogel… (NCT06716385) | Clinical Trial Compass
CompletedNot Applicable
A Clinical Trial to Evaluate the Vision Correction Safety and Efficacy of MSiHy Silicone Hydrogel Soft Contact Lens
Taiwan134 participantsStarted 2024-10-09
Plain-language summary
This is a prospective, randomized, double-blind, parallel, active-controlled, multi-center clinical study. The purpose is to evaluate the safety and effectiveness wearing "MSiHy Silicone Hydrogel Soft Contact Lens".
Subjects will be randomized in 1:1 ratio to wear either the investigational device "MSiHy Silicone Hydrogel Soft Contact Lens" or the control device Monthly Silicone Hydrogel Contact Lenses(oA)".
Who can participate
Age range
18 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
. Must be 18 years of age inclusive
. Beside myopia and astigmatism, subjects with normal eyes and 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 +8.00D \~ -12.00 D spherical component myopia, and ≤1.00 astigmatism (based on manifest refraction measurements)
. Have worn soft contact lens for at least 2 month prior to the study
. Willing to comply with the required wearing time
. Agree to comply with all study procedures, sign and date the informed consent form before starting the clinical study
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.
1This trial has already been completed — is the data from it published or available yet, and does any of it apply to my level of myopia or refractive error?
2Since this trial was studying a specific silicone hydrogel contact lens called MSiHy for vision correction, how does this lens compare to the silicone hydrogel lenses I might already be considering or currently wearing?
3The trial measured visual correction as its main outcome — based on completed results, do you know whether this lens performed well enough across different prescriptions, including mine, to be worth considering?
4Because this was a safety and efficacy trial with no listed phase, what does that mean for how confident we can be in the safety profile of this lens compared to contact lenses that have been on the market longer?
5Are there standard contact lens options already approved and widely used that you would recommend I compare against this MSiHy lens before deciding what's best for my eyes?
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.
. Anterior segment 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
. Currently using systemic or ocular medications that would contraindicate contact lens wear (such as glaucoma eye drops, steroid anti-inflammatory drops, eye ointments, eye gels and other eye medicines)
. History of herpetic 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)
. A pathologically dry eye (Schirmer test 1 \<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)