13 weeks, open-label, daily disposable contact lens dispensing study.
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;
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;
Single group
Treatment
DeviceTest 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.
Total suspended eye(s)
To evaluate the safety of study lenses by the total suspended eye(s) occurrence rate during the study period.
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).
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.
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.
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.
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