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

NCT07322211 | Recruiting DMC

• 1 other identifier: UNC-002
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Refractive Ametropia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Tabulation of Discontinued Eye(s)

  From enrollment to the end of treatment at 13 weeks

• Tabulation of Subjective Symptoms

  From enrollment to the end of treatment at 13 weeks

• Tabulation of Slit-Lamp Microscopy Findings

  From enrollment to the end of treatment at 13 weeks

• Tabulation of Adverse Event(s)

  From enrollment to the end of treatment at 13 weeks

• Tabulation of Adverse Device Effect(s)

  From enrollment to the end of treatment at 13 weeks

Study Arms (1)

Open-label, single-arm, dispensing study.

EXPERIMENTAL

Qualis (linofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens

Device: Treatment

Interventions

Treatment DEVICE

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.

Open-label, single-arm, dispensing study.

Eligibility Criteria

• Age: 18 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Unicon Optical Co. Ltd.: lead

Study Sites (2)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

RECRUITING

Linkou Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

RECRUITING

Related Publications (5)

• WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects. 75th WMA General Assembly, Helsinki, Finland, October 2024.

  BACKGROUND

• ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice.

  BACKGROUND

• ISO 11980:2012 Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations.

  BACKGROUND

• 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.

  PMID: 25574042 BACKGROUND

• 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).

  BACKGROUND

MeSH Terms

Interventions

Therapeutics

Central Study Contacts

Nick Liao

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 7, 2026
• Study Start: January 20, 2026
• Primary Completion (Estimated): July 20, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)