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OpenTrials
Completed

NCT Number: NCT03567005

Clinical Validation of DACP Digital Design

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.

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Key information

Conditions

Refractive Errors Eye Diseases

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alcon Investigative Site, Bloomington, Illinois, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nelfilcon A digital contact lenses

Device

Silicone hydrogel digital contact lenses

Other names: DAILIES® AquaComfort Plus® Digital, DACP Digital

Nelfilcon A contact lenses

Device

Silicone hydrogel spherical contact lenses

Other names: DAILIES® AquaComfort Plus®, DACP

Primary outcomes

  1. Distance Visual Acuity (VA) (logMAR, OU)

    Time frame: 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 outcomes

  1. Overall Vision

    Time frame: Day 7, each product

    Subjective rating of overall vision on a scale of 1 (Poor) to 10 (Excellent). Both eyes contributed to the analysis.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 25, 2018
Registry last updated
Jun 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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