Clinical Validation of DACP Digital Design

Refractive Errors Clinical Trial

Official title:

Clinical Validation of DACP Digital Design

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03567005
• Other study ID #: CLD523-C001
• Status: Completed
• Phase: N/A
• Start date: June 25, 2018
• Est. completion date: August 26, 2018

Study information

• Verified date: May 2019
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 26, 2018
• Est. primary completion date: August 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

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.

Related Conditions & MeSH terms

• Refractive Errors

Intervention

Device:
• Nelfilcon A digital contact lenses
Silicone hydrogel digital contact lenses
• Nelfilcon A contact lenses
Silicone hydrogel spherical contact lenses

Locations

Country	Name	City	State
United States	Alcon Investigative Site	Bloomington	Illinois
United States	Alcon Investigative Site	Brentwood	Tennessee
United States	Alcon Investigative Site	Memphis	Tennessee
United States	Alcon Investigative Site	Memphis	Tennessee
United States	Alcon Investigative Site	Powell	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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