A Study to Evaluate the Clinical Performance and Safety of UNICON Silicone Hydrogel Daily Disposable Soft Contact Lenses

Recruiting now · Not applicable

Conditions studied: Refractive Ametropia

In brief

13 weeks, open-label, daily disposable contact lens dispensing study.

Key facts

Study ID

NCT07322211

Run by

Unicon Optical Co. Ltd.

People needed

35

Starts

2026-01-20

Expected to finish

2026-10-31

Last updated by the study team

2026-01-22

Who can join

Age: 0 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult with an age ≥ 18;
• 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);
• Participant must be stop wearing any contact lenses more than 7 days prior to screening;
• Able to wear contact lenses within a range of power from -2.00D to -6.00D (0.25 D steps) in both eyes;
• Astigmatism of 1.25D or less in both eyes;
• Be correctable to a visual acuity of 1.0 decimal (0.0 logMAR) or better in each eye;
• Participant must be able to be successfully fit with study lenses;
• The participant must appear able and willing to adhere to the instructions set forth in this clinical protocol;
• The participant must read and sign the Informed Consent Form.

You may not qualify if…

• Women who are currently pregnant;
• Women who are lactating or planning a pregnancy at the time of enrollment (by verbal confirmation at the screening visit);
• 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;
• Any current or history ocular or systemic disease which may interfere with contact lens wear, as determined by the investigator;
• Any current or previous orthokeratology treatment within 90 days prior to study enrollment, or planned for orthokeratology treatment during the study;
• 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;
• Current or history of herpetic keratitis in either eye;
• Current or history of intolerance, hypersensitivity or allergy to silicone hydrogel soft contact lenses or any component of the study products;
• 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;
• Employee of Department of Ophthalmology and clinic (e.g., Investigator, Coordinator, Technician);
• Participation in any interventional clinical trial within 30 days prior to study enrollment;
• 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;
• 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;
• Any anterior segment infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the investigator;
• Participants are considered ineligible for the study as judged by the investigator.

Where it is running

• Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City, Taiwan (enrolling)
• Linkou Chang Gung Memorial Hospital — Taoyuan, Taiwan (enrolling)

Full record on ClinicalTrials.gov

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