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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
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.
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
RECRUITINGLinkou Chang Gung Memorial Hospital
Taoyuan District, Taiwan
RECRUITINGTotal suspended eye(s)
To evaluate the safety of study lenses by the total suspended eye(s) occurrence rate during the study period.
Time frame: From enrollment to the end of treatment at 13 weeks
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From enrollment to the end of treatment at 13 weeks
Tabulation of Adverse Device Effect(s)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From enrollment to the end of treatment at 13 weeks