Tear Film Stability of DAILIES® AquaComfort Plus® Contact Lenses vs. MyDay® Daily Disposable Contact Lenses

Alcon

Status: Completed

Conditions: Refractive Error

Treatments: Device: Nelfilcon A contact lenses; Device: Stenfilcon A contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT02089191

M-14-006

Details and patient eligibility

About

The purpose of this study is to evaluate tear film stability of DAILIES® AquaComfort Plus® (DACP) compared to MyDay® after 12 hours of lens wear.

Enrollment: 31 patients

Sex: All

Ages: 18 to 44 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must sign an Informed Consent form;
• Adapted, current soft contact lens wearer;
• Required contact lens prescription within the power range specified in the protocol (+6.00 to -10.00 diopters (D));
• Cylinder ≤ -1.00 D in both eyes at Visit 1;
• Vision correctable to 0.1 logarithm of the Minimum Angle of Resolution (logMAR) or better in each eye at distance with pre-study lenses at Visit 1;
• Willing to wear study lenses up to 12 hours and attend all study visits;
• Able to be successfully fitted with study lenses;
• Unstable tear film with a NIK-BUT value below 13 seconds in either eye without lenses;
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Any ocular infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
• Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator;
• Use of artificial tears and rewetting drops during the study;
• Monocular (only 1 eye with functional vision) or fit with only 1 lens;
• Any abnormal ocular condition observed during Visit 1;
• History of herpetic keratitis, ocular surgery, or irregular cornea;
• Pregnant or lactating;
• Participation in any clinical study within 30 days of Visit 1;
• Current MyDay® or DAILIES® AquaComfort Plus® lens wearer;
• Other protocol-defined exclusion criteria may apply.

Trial design

31 participants in 2 patient groups

DACP/MyDay

Other group

Description:

Nelfilcon A contact lenses worn in Period 1, with stenfilcon A contact lenses in Period 2. Each product worn bilaterally for 12 hours over 1 day.

Treatment:

Device: Stenfilcon A contact lenses

Device: Nelfilcon A contact lenses

MyDay/DACP

Other group

Description:

Stenfilcon A contact lenses worn in Period 1, with nelfilcon A contact lenses in Period 2. Each product worn bilaterally for 12 hours over 1 day.

Treatment:

Device: Stenfilcon A contact lenses

Device: Nelfilcon A contact lenses