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

NCT07322211•Unicon Optical Co. Ltd.

Summary

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

Detailed Description

The purpose of this clinical study is to evaluate the safety and clinical performance of the investigational soft contact lens when worn in a daily wear modality, by assessing total suspended eye(s) as the primary variable.

Eligibility

Age

0 - No limit years

Sex

ALL

Healthy Volunteers

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);
+5 more criteria

Locations (2)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Linkou Chang Gung Memorial Hospital

Taoyuan District, Taiwan

Key Dates

Start Date

January 20, 2026

Primary Completion Date

July 20, 2026

Completion Date

October 31, 2026

Last Updated

January 22, 2026

Enrollment

ESTIMATED participants

Conditions

Refractive Ametropia

Interventions

Treatment

DEVICE

Contacts

Nick Liao

CONTACT

+886-3-5775586 ra@uniconvision.com.tw

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 22, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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