New contact lens aims to correct nearsightedness safely
NCT ID NCT06716372
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This completed study tested a new daily disposable contact lens called DSiHy for correcting nearsightedness (myopia). 134 adults who already wore contacts were randomly assigned to use either the new lens or a standard daily lens. The goal was to see if the new lens provides clear vision (20/20 or better) and is safe to wear.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- DSiHy Silicone Hydrogel Soft Contact Lens
- What this could lead to
- If successful, this could offer a new daily disposable contact lens option for people with nearsightedness, providing clear vision with good safety.
- What could go wrong
- This is a completed trial comparing two similar contact lenses, so major breakthroughs are unlikely. The main risk is typical contact lens discomfort or eye irritation.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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134 people
The number who actually took part.
- Started
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Oct 2024
- Finished
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Aug 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Must be 18 years of age inclusive 2. Beside myopia and astigmatism, subjects with normal eyes and are not using any ocular medications (excluding ocular lubricants and artificial tears) 3. Best spectacle corrected visual acuity greater than or equal to 1.0 for both eyes 4. With +8.00D \~ -12.00 D spherical component myopia, and ≤1.00 astigmatism (based on manifest refraction measurements) 5. Have worn soft contact lens for at least 2 month prior to the study 6. Willing to comply with the required wearing time 7. Agree to comply with all study procedures, sign and date the informed consent form before starting the clinical study Exclusion Criteria: 1. Anterior segment infection, inflammation or abnormality 2. 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 3. 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) 4. History of herpetic keratitis 5. History of refractive surgery, keratoconus or irregular cornea 6. 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) 7. A pathologically dry eye (Schirmer test 1 \<5 mm) 8. Have participated in any contact lens or contact lens care product clinical trials within the previous 1 month (excluding questionnaire types and specimen collection) 9. Currently pregnant, lactating, or planning to be pregnant during the trial 10. Have experienced discomfort when wearing silicone hydrogel contact lens, or a known allergy to hyaluronic acid and sodium alginate 11. Corrected visual acuity in either eye does not reach 1.0 when wearing the trial lens 12. Subjects who are judged by the investigators as unsuitable for the study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Chang Gung Memorial Hospital, Linkou
Taoyuan, Taiwan
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Chang Gung Memorial Hospital, Taipei
Taipei, Taiwan
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Tri-Service General Hospital
Taipei, 114202, Taiwan
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