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

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

Study Overview

• Status: Recruiting
• Conditions: Refractive Ametropia
• Intervention / Treatment: Device: Treatment

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.

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nick Liao; Phone Number: 1307 +886-3-5775586; Email: ra@uniconvision.com.tw

Study Locations

• Taiwan
  • Kaohsiung City, Taiwan, 807
    • Recruiting
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
    • Contact: Hsu Doctor; Phone Number: 886-7-3121101; Email: shiuhlianghsu@gmail.com
    • Principal Investigator: Hsu SL
  • Taoyuan District, Taiwan, 333
    • Recruiting
    • Linkou Chang Gung Memorial Hospital
    • Contact: Hwang Doctor; Phone Number: +886-3-3281200; Email: yihshiou.hwang@gmail.com
    • Principal Investigator: Hwang YS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Open-label, single-arm, dispensing study.; Qualis (linofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens	Device: Treatment; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total suspended eye(s)	To evaluate the safety of study lenses by the total suspended eye(s) occurrence rate during the study period.	From enrollment to the end of treatment at 13 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tabulation of Discontinued Eye(s)	A tabulation of eyes discontinued from the study with reasons and the safety evaluation of the investigational lens evaluated based on these eye(s).	From enrollment to the end of treatment at 13 weeks
Tabulation of Subjective Symptoms	Participant's symptoms, problems, and complaints will be collected via questionnaires and interviews at each visit. A tabulation of reported subjective symptoms will be compiled by visit and incidence rate, and the safety of the investigational lens will be evaluated accordingly.	From enrollment to the end of treatment at 13 weeks
Tabulation of Slit-Lamp Microscopy Findings	Anterior segment findings observed during slit-lamp examination will be assessed according to the Slit-Lamp Examination Criteria (Appendix 1). A tabulation of slit lamp findings by visit, eyes and incidence rate will be created, and the safety of the investigational lens will be evaluated based on these findings.	From enrollment to the end of treatment at 13 weeks
Tabulation of Adverse Event(s)	A tabulation of adverse event(s) (AEs) and serious adverse event(s) (SAEs) occurring during the study period will be created, and an assessment of the safety of the investigational lens will be conducted.	From enrollment to the end of treatment at 13 weeks
Tabulation of Adverse Device Effect(s)	A tabulation of adverse device effect(s) (ADEs) and serious adverse device effects (SADEs) will be created. Calculate the incidence rates, and the safety of the investigational lens will be evaluated accordingly.	From enrollment to the end of treatment at 13 weeks
Tabulation of Device Deficiencies	A tabulation of Device Deficiencies occurring during the trial will be compiled, and the safety of the investigational lens will be evaluated.	From enrollment to the end of treatment at 13 weeks
Contact Lens Corrected Visual Acuity	The percentage of eyes achieving a lens-corrected visual acuity of ≥1.0 decimal (0.0 logMAR) at the final visit will be evaluated. If an eye does not achieve a visual acuity of 1.0 with the contact lens alone, but attains ≥1.0 after additional correction with spectacles, it shall be considered as meeting the 1.0 threshold.	From enrollment to the end of treatment at 13 weeks
Mean of Contact Lens Corrected Visual Acuity	The mean of lens-corrected visual acuity (best corrected visual acuity while wearing the lenses) at the final examination will be calculated. The lower limit of the 95% confidence interval (95% CImin) will be statistically evaluated to confirm that it is ≥1.0.	From enrollment to the end of treatment at 13 weeks

Collaborators and Investigators

• Sponsor: Unicon Optical Co. Ltd.

Publications and helpful links

General Publications

• WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects. 75th WMA General Assembly, Helsinki, Finland, October 2024.
• ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice.
• ISO 11980:2012 Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations.
• Chalmers RL, Hickson-Curran SB, Keay L, Gleason WJ, Albright R. Rates of adverse events with hydrogel and silicone hydrogel daily disposable lenses in a large postmarket surveillance registry: the TEMPO Registry. Invest Ophthalmol Vis Sci. 2015 Jan 8;56(1):654-63. doi: 10.1167/iovs.14-15582.
• Approaches to Clinical Evaluation of Standard Contact Lenses 標準的なコンタクトレンズの臨床評価に関する考え方 (Japan Independent Industry Guidelines 業界自主指針; August 1, 2009 平成21 年8 月1 日).

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2026
• Primary Completion (Estimated): July 20, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: December 22, 2025
• First Submitted That Met QC Criteria: December 22, 2025
• First Posted (Actual): January 7, 2026

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics
• Other Study ID Numbers: UNC-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This study is intended for internal re-verification of the company's products and is not intended for external disclosure or use.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No