A Clinical Trial to Evaluate the Vision Correction Safety and Efficacy of DSiHy Silicone Hydrogel… (NCT06716372) | Clinical Trial Compass
CompletedNot Applicable
A Clinical Trial to Evaluate the Vision Correction Safety and Efficacy of DSiHy Silicone Hydrogel Soft Contact Lens
Taiwan134 participantsStarted 2024-10-07
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 "DSiHy Silicone Hydrogel Soft Contact Lens". Subjects will be randomized in 1:1 ratio to wear either the investigational device "DSiHy Silicone Hydrogel Soft Contact Lens" or the control device Daily Silicone Hydrogel Contact Lenses(oB)".
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 was listed as Phase NA and has already completed — does that mean there's published safety and effectiveness data on the DSiHy silicone hydrogel lens that you could review with me before I consider it?
2Since this trial was specifically measuring visual correction for myopia and refractive errors, how does the correction this lens provides compare to other silicone hydrogel lenses or options like glasses and laser surgery that might already be available to me?
3Silicone hydrogel materials are known for oxygen permeability, but how would you assess whether the DSiHy lens's specific material and design are a good fit for my particular prescription and eye health?
4Because the trial is completed but I don't know if the lens is commercially approved yet, can you check on the current regulatory status of this lens and whether it's something I could actually access right now?
5Given that my myopia correction needs are ongoing, what questions should I be asking about long-term comfort and eye health with any new silicone hydrogel lens, based on what this trial did or didn't measure?
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)