New contact lenses put to the test: are they safe for daily wear?
NCT ID NCT07322211
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
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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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About 35 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- 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 days 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. 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.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITINGKaohsiung City, 807, Taiwan
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Linkou Chang Gung Memorial Hospital
RECRUITINGTaoyuan, 333, Taiwan
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