Clinical Validation of DACP Digital Design

Alcon

Status: Completed

Conditions: Refractive Errors

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03567005

CLD523-C001

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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60 participants in 2 patient groups

DACP Digital then DACP

Other group

Description:

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.

Treatment:

Device: Nelfilcon A contact lenses

Device: Nelfilcon A digital contact lenses

DACP then DACP Digital

Other group

Description:

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.

Treatment:

Device: Nelfilcon A contact lenses

Device: Nelfilcon A digital contact lenses