Habitual current daily disposable soft contact lenses wearers with symptoms of contact lens discomfort.
Conditions
Interventions
DAILIES TOTAL 1, then 1-DAY ACUVUE TruEye
1-DAY ACUVUE TruEye, then DAILIES TOTAL 1
Sponsors
Alcon Japan Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Must sign an informed consent form; Habitual current disposable contact lenses wearer. Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility) Questionnaire. Lenses within power range specified in the protocol. Vision correctable to 0.8 or 0.1 logMAR (logarithmic minimum angle of resolution) or better in each eye at distance with pre-study contact lenses at Visit 1. Willing to wear lenses every day or at least for a minimum of 10 days, 6 hours per day, every day if possible and attend all study visits. Other protocol-specified inclusion criteria may apply.
Exclusion criteria
Exclusion criteria: Currently wearing DAILIES TOTAL 1 or 1-DAY ACUVUE TruEye sphere lenses. Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear. Use of systemic or ocular medications in which contact lens wear could be contraindicated as determined by the investigator. Eye injury or surgery within 12 weeks immediately prior to enrollment. History of herpetic keratitis, ocular surgery or irregular cornea. Prior refractive surgery. Monocular (only 1 eye with functional vision) or fit with only 1 lens. Participation in any clinical trial within 30 days of the enrollment visit. Other protocol-specified exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Investigator-rated successful lens centration of Optimal after 7 to 13 days of wearing. | — |
Countries
Japan
Contacts
Public ContactMitsugu Watanabe
Alcon Japan Ltd. Phase IV, Clinical & Regulatory Affairs Division Medical Affairs
Outcome results
None listed