Clinical Validation of DACP Digital Design

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Validation of DACP Digital Design

Conditions
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Refractive Errors

Intervention / Treatment
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* Device: Nelfilcon A digital contact lenses
* Device: Nelfilcon A contact lenses


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: DACP Digital then DACP<br>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. | Device: Nelfilcon A digital contact lenses<br>* Silicone hydrogel digital contact lenses<br>* Other names: DACP Digital;Device: Nelfilcon A contact lenses<br>* Silicone hydrogel spherical contact lenses<br>* Other names: DACP;|
| Other: DACP then DACP Digital<br>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. | Device: Nelfilcon A digital contact lenses<br>* Silicone hydrogel digital contact lenses<br>* Other names: DACP Digital;Device: Nelfilcon A contact lenses<br>* Silicone hydrogel spherical contact lenses<br>* Other names: DACP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance Visual Acuity (VA) (logMAR, OU) | 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. | Day 7, each product | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Vision | Subjective rating of overall vision on a scale of 1 (Poor) to 10 (Excellent). Both eyes contributed to the analysis. | Day 7, each product |