DAILIES TOTAL1® Lens Centration in a Japanese Population

Alcon

Status: Completed

Conditions: Myopia; Refractive Error

Treatments: Device: Narafilcon A contact lenses; Device: Delefilcon A contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT02252133

ALJ-V2014-1

Details and patient eligibility

About

The purpose of this study is to compare the lens centration of DAILIES TOTAL1® (DT1) contact lenses to 1-DAY ACUVUE® Tru-Eye® (1DAVTE) contact lenses in a Japanese population after 7 ± 2 days of wearing of each product.

Enrollment: 53 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Sign Informed Consent document.
• Habitually wear soft contact lenses on a daily disposable or weekly/monthly replacement basis.
• Symptoms of contact lens discomfort as defined by protocol.
• Require contact lenses within the power range of -0.50 diopter (D) to -10.00 D.
• Cylinder, if present, less or equal to 0.75D in either eyes at Visit 1.
• Vision correctable to 20/25 or 0.1 (logMAR) or better in each eye at distance with pre-study lenses at Visit 1.
• Acceptable contact lens fit with both study contact lenses.
• Willing to wear lenses every day for at least for a minimum of five days per week six hours per day, every day if possible and attend all study visits.
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Currently wearing DT1 or 1DAVTE.
• Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear.
• Use of systemic or ocular medications which contact lens wear could be contraindicated as determined by the investigator.
• Eye injury or surgery within twelve weeks immediately prior to enrollment for this trial.
• Any moderate or severe ocular condition observed during the slit-lamp examination at the enrollment visit.
• History of herpetic keratitis, ocular surgery or irregular cornea.
• Prior refractive surgery (e.g. LASIK, PRK, etc).
• Monocular subjects (only one eye with functional vision) or subjects fit with only one lens.
• Judged ineligible as a patient in this clinical study by the investigator.
• Other protocol-defined exclusion criteria may apply.

Trial design

53 participants in 2 patient groups

DT1, then 1DAVTE

Other group

Description:

Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product worn bilaterally for 7 days on a daily wear, daily disposable basis.

Treatment:

Device: Delefilcon A contact lenses

Device: Narafilcon A contact lenses

1DAVTE, then DT1

Other group

Description:

Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product worn bilaterally for 7 days on a daily wear, daily disposable basis.

Treatment:

Device: Delefilcon A contact lenses

Device: Narafilcon A contact lenses