Clinical Validation of DACP Digital Design

Not Applicable

Completed

• Conditions: Refractive Errors

• Registration Number: NCT03567005
• Lead Sponsor: Alcon Research

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-13
• Study First Submitted QC: 2018-06-13
• Study Start: 2018-06-25
• Study First Posted: 2018-06-25
• Primary Completion: 2018-08-26
• Study Completion: 2018-08-26
• Status Verified: 2019-05
• Results First Submitted: 2019-05-28
• Results First Submitted QC: 2019-05-28
• Last Update Submitted: 2019-05-28
• Results First Posted: 2019-06-18
• Last Update Posted: 2019-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

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

Name	Time	Method
Overall Vision	Day 7, each product	Subjective rating of overall vision on a scale of 1 (Poor) to 10 (Excellent). Both eyes contributed to the analysis.

Trial Locations

Locations (1)

Alcon Investigative Site; 🇺🇸 Memphis, Tennessee, United States