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13 weeks, open-label, daily disposable contact lens dispensing study.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-label, single-arm, dispensing study. | Experimental | Qualis (linofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nick Liao | Contact | +886-3-5775586 | 1307 | ra@uniconvision.com.tw |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Recruiting | Kaohsiung City | 807 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| 25574042 | 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. |
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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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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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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 |
| Linkou Chang Gung Memorial Hospital | Recruiting | Taoyuan | 333 | Taiwan |
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| 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). |