Clinical Validation of DACP Digital Design

Not Applicable

Completed

Interventions: Device: Nelfilcon A digital contact lenses
Device: Nelfilcon A contact lenses

Brief Summary: The purpose of this study is to evaluate the visual performance of DAILIES® AquaComfort Plus® (DACP) Digital lenses by assessing distance visual acuity (VA) as compared to DACP sphere contact lenses after one week of wear.

Recruitment & Eligibility

Inclusion Criteria

Willing and able to sign an IRB/IEC approved Informed Consent form;
Current wearer of DACP spherical contact lenses (at least 2 months in current correction), with a minimum wearing time of 5 days per week and 8 hours per day;
Experiencing symptoms of eye strain from using technology;
Willing to wear study lenses each day;
Possess spectacles that provide a corrected visual acuity of 20/40 or better in both eyes (OU) and be willing to wear them (as needed);
Willing to NOT use rewetting/lubricating drops at any time during the study;
Currently using digital devices (computer, tablet, and/or smart phone) for a minimum of 5 days per week and 4 hours per day;
Willing to NOT use any near aid (e.g. reading glasses) at any time during the study.

Exclusion Criteria

Conditions, use of medications, injury, or surgery, as specified in the protocol;
Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
Monocular (only one eye with functional vision);
Pregnant.

Arm && Interventions

Group	Intervention	Description
DACP then DACP Digital	Nelfilcon A digital contact lenses	Nelfilcon A contact lenses worn first, followed by nelfilcon A digital contact lenses. Each product worn bilaterally for 7 days in a daily disposable modality.
DACP Digital then DACP	Nelfilcon A digital contact lenses	Nelfilcon A digital contact lenses worn first, followed by nelfilcon A contact lenses. Each product worn bilaterally (in both eyes) for 7 days in a daily disposable modality.
DACP Digital then DACP	Nelfilcon A contact lenses	Nelfilcon A digital contact lenses worn first, followed by nelfilcon A contact lenses. Each product worn bilaterally (in both eyes) for 7 days in a daily disposable modality.
DACP then DACP Digital	Nelfilcon A contact lenses	Nelfilcon A contact lenses worn first, followed by nelfilcon A digital contact lenses. Each product worn bilaterally for 7 days in a daily disposable modality.

Primary Outcome Measures

Name	Time	Method
Distance Visual Acuity (VA) (logMAR, OU)	Day 7, each product	VA was tested under photopic (well-lit) conditions using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart positioned 6 meters from the subject. VA was collected bilaterally (OU) and measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower numeric value represents better visual acuity.

Secondary Outcome Measures