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New contact lens aims to correct nearsightedness safely

NCT ID NCT06716385

Disease control Sponsor: Visco Vision Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new silicone hydrogel contact lens (MSiHy) for correcting nearsightedness. 134 adults who already wore contacts were randomly assigned to try either the new lens or a standard monthly lens. The goal was to see if the new lens provides clear vision 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
MSiHy Silicone Hydrogel Soft Contact Lens
What this could lead to
If successful, this could offer a new, safe, and effective option for daily-wear monthly-disposable contact lenses for people with nearsightedness.
What could go wrong
This is a completed trial with 134 participants, so results are limited. The new lens may not be significantly better than existing lenses, and individual comfort or vision quality may vary.

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

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

134 people

The number who actually took part.

Started

Oct 2024

Finished

Aug 2025

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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. Allergy to any contact lens care product ingredient 12. Corrected visual acuity in either eye does not reach 1.0 when wearing the trial lens 13. Subjects who are judged by the investigators as unsuitable for the study

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Conditions

The condition(s) this trial relates to.

myopia refractive error

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Myopia Refractive errors

Contacts and locations

Locations

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan, Taiwan

  • MayKay Memorial Hospital

    Taipei, 10449, Taiwan

  • Tri-Service General Hospital

    Taipei, 114202, Taiwan

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