RecruitingNot Applicable

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

Taiwan35 participantsStarted 2026-01-20

Plain-language summary

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

Age range18 Days

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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;

✕. 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;

Total suspended eye(s)

Timeframe: From enrollment to the end of treatment at 13 weeks

NCT IDNCT07322211

SponsorUnicon Optical Co. Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-07-20

Nick Liao

Who can participate

Age range18 Days

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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;

✕. 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;