Refractive AmetropiaNCT07322211
A Study to Evaluate the Clinical Performance and Safety of UNICON Silicone Hydrogel Daily Disposable Soft Contact Lenses
A study testing Treatment in people with Refractive Ametropia, run by Unicon Optical Co. Ltd. at 2 sites in Taiwan.
Trial summary
13 weeks, open-label, daily disposable contact lens dispensing study. Read more about this study
- Who is it for?
- Ages 18 days and older
- Conditions the study is for
- Refractive Ametropia
- What is being tested?
- Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesTaiwan
- Study dates
- 20 Jan 2026to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan2 sites, 2 recruiting
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
Hsu Doctor, 886-7-3121101, shiuhlianghsu@gmail.com
Hsu SL
- Recruiting
Linkou Chang Gung Memorial Hospital
Taoyuan, 333
Hwang Doctor, +886-3-3281200, yihshiou.hwang@gmail.com
Hwang YS
About this study
13 weeks, open-label, daily disposable contact lens dispensing study.
Read the 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.
- Conditions
- Refractive Ametropia
- Being tested
- Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreatmentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Open-label, single-arm, dispensing study. | Experimental | Qualis (linofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens Receives: Device: Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total suspended eye(s)
To evaluate the safety of study lenses by the total suspended eye(s) occurrence rate during the study period.
Measured: From enrollment to the end of treatment at 13 weeks
Secondary outcomes (8)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start20 Jan 2026
- Primary completion20 Jul 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Refractive AmetropiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unicon Optical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07322211
- Sponsor's protocol ID
- UNC-002
- Status last verified
- Jan 2026
- First submitted
- 22 Dec 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study is intended for internal re-verification of the company's products and is not intended for external disclosure or use.
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.
PubMed 25574042Approaches 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 at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Clinical Performance and Safety of UNICON Silicone Hydrogel Daily Disposable Soft Contact Lenses
- ClinicalTrials.gov ID
- NCT07322211
- Acronym / sponsor ID
- UNC-002
- Conditions
- Refractive Ametropia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Unicon Optical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- 20 Jul 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-label, single-arm, dispensing study. | Experimental | Device: TreatmentQualis (linofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens |
Who may qualify
- Ages
- 18 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TreatmentTest 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. | Device | Open-label, single-arm, dispensing study. |
Primary outcome
Total suspended eye(s)
Time frame: From enrollment to the end of treatment at 13 weeks
To evaluate the safety of study lenses by the total suspended eye(s) occurrence rate during the study period.
8 secondary outcomes
Tabulation of Discontinued Eye(s)
Time frame: From enrollment to the end of treatment at 13 weeks
Tabulation of Subjective Symptoms
Time frame: From enrollment to the end of treatment at 13 weeks
Tabulation of Slit-Lamp Microscopy Findings
Time frame: From enrollment to the end of treatment at 13 weeks
Tabulation of Adverse Event(s)
Time frame: From enrollment to the end of treatment at 13 weeks
Tabulation of Adverse Device Effect(s)
Time frame: From enrollment to the end of treatment at 13 weeks
Tabulation of Device Deficiencies
Time frame: From enrollment to the end of treatment at 13 weeks
Contact Lens Corrected Visual Acuity
Time frame: From enrollment to the end of treatment at 13 weeks
Mean of Contact Lens Corrected Visual Acuity
Time frame: From enrollment to the end of treatment at 13 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- BackgroundWMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects. 75th WMA General Assembly, Helsinki, Finland, October 2024.
- BackgroundISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice.
- BackgroundISO 11980:2012 Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations.
- Background: PubMed 25574042Chalmers 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.
- BackgroundApproaches 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).
- Individual participant dataSharing planned: No. This study is intended for internal re-verification of the company's products and is not intended for external disclosure or use.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment in people with Refractive Ametropia, run by Unicon Optical Co. Ltd. at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nick Liao (+886-3-5775586 ext. 1307, ra@uniconvision.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total suspended eye(s) (time frame: From enrollment to the end of treatment at 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07322211, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026; AzTrials last refreshed its copy on 30 Oct 2026.