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New contact lenses put to the test: are they safe for daily wear?

NCT ID NCT07322211

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a new type of daily disposable contact lens called UNICON. It will involve 35 adults who already wear soft contact lenses. Participants will wear the test lenses for up to 13 weeks to see if they are safe and comfortable for correcting nearsightedness.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
UNICON silicone hydrogel daily disposable soft contact lenses
What this could lead to
If successful, this could confirm that these contact lenses are safe and comfortable for everyday vision correction.
What could go wrong
This is a small, early-stage study with only 35 participants, so results may not apply to everyone. There is always a risk of eye irritation or infection with contact lens use.

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

About 35 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Oct 2026

An estimate. End dates often move.

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 days 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. Adult with an age ≥ 18; 2. Be a currently adapted soft contact lens wearer who successful wear of soft contact lenses in both eyes for a minimum of 5 days per week and 6 hours per day within 3 months prior to study screening (by verbal confirmation); 3. Participant must be stop wearing any contact lenses more than 7 days prior to screening; 4. Able to wear contact lenses within a range of power from -2.00D to -6.00D (0.25 D steps) in both eyes; 5. Astigmatism of 1.25D or less in both eyes; 6. Be correctable to a visual acuity of 1.0 decimal (0.0 logMAR) or better in each eye; 7. Participant must be able to be successfully fit with study lenses; 8. The participant must appear able and willing to adhere to the instructions set forth in this clinical protocol; 9. The participant must read and sign the Informed Consent Form. Exclusion Criteria: 1. Women who are currently pregnant; 2. Women who are lactating or planning a pregnancy at the time of enrollment (by verbal confirmation at the screening visit); 3. Any use of systemic or ocular medications (e.g., non-steroidal anti-inflammatory eye drops, ophthalmic steroids) within 30 days prior to study enrollment for which contact lens wear could be contraindicated, as determined by the investigator; 4. Any current or history ocular or systemic disease which may interfere with contact lens wear, as determined by the investigator; 5. Any current or previous orthokeratology treatment within 90 days prior to study enrollment, or planned for orthokeratology treatment during the study; 6. Any previous history of ocular and/or refractive surgery (e.g., radial keratotomy, PRK, LASIK, etc.) or planned for ocular and/or refractive surgery during the study; 7. Current or history of herpetic keratitis in either eye; 8. Current or history of intolerance, hypersensitivity or allergy to silicone hydrogel soft contact lenses or any component of the study products; 9. Current clinical finding of entropion, ectropion, chalazia, recurrent styes, glaucoma, pathologically dry eye (defined as Schirmer test \< 5 mm/5 min), recurrent corneal erosions, aphakia, or moderate or above corneal distortion; 10. Employee of Department of Ophthalmology and clinic (e.g., Investigator, Coordinator, Technician); 11. Participation in any interventional clinical trial within 30 days prior to study enrollment; 12. Any biomicroscopy findings at screening that are Grade 3 or higher and/or corneal neovascularization that is Grade 2 or higher and/or presence of corneal infiltrates; 13. Any history of a contact lens-related corneal inflammatory or infectious event within 12 months prior to study enrollment that may contraindicate contact lens wear; 14. Any anterior segment infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the investigator; 15. Participants are considered ineligible for the study as judged by the investigator.

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    RECRUITING

    Kaohsiung City, 807, Taiwan

  • Linkou Chang Gung Memorial Hospital

    RECRUITING

    Taoyuan, 333, Taiwan

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