RecruitingNot ApplicableNCT07322211
A Study to Evaluate the Clinical Performance and Safety of UNICON Silicone Hydrogel Daily Disposable Soft Contact Lenses
Sponsor
Unicon Optical Co. Ltd.
Enrollment
35 participants
Start Date
Jan 20, 2026
Study Type
INTERVENTIONAL
Conditions
Summary
13 weeks, open-label, daily disposable contact lens dispensing study.
Eligibility
Min Age: 18 Days
Inclusion Criteria9
- 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.
Exclusion Criteria15
- 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.
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Interventions
DEVICETreatment
Test lenses will be worn on a daily disposable basis for up to 13 weeks. Subjects will be instructed to wear the test lenses at least 6 hours a day, a minimum of 5 days per week.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07322211