Comparison of Two Daily Disposable Lenses

Myopia Clinical Trial

Official title:

Comparison of Two Daily Disposable Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04013789
• Other study ID #: CLD523-P001
• Status: Completed
• Phase: N/A
• Start date: August 27, 2019
• Est. completion date: November 22, 2019

Study information

• Verified date: November 2020
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to compare the clinical performance of the new DAILIES® AquaComfort PLUS® FreshTech (DACP FreshTech) contact lenses to an already marketed daily disposable contact lens, DAILIES® AquaComfort PLUS® (DACP).

Description:

Subjects attended 4 scheduled visits for an expected duration of participation of 3 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: November 22, 2019
• Est. primary completion date: November 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• At least 3 months of soft contact lens wearing experience;
• Wears habitual lenses at least 5 days per week and at least 8 hours per day;
• Uses digital devices (computer, tablet, and/or smart phone) for an average of 4 hours per day;
• Experiences eye fatigue at least once per week attributable to digital device use with habitual lenses;
• Is willing to NOT use rewetting/lubricating drops during the period of study product exposure;
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Routinely sleeps in contact lenses;
• Known pregnancy at time of enrollment;
• Binocular vision issues or issues of eye alignment;
• Any eye infection, inflammation, disease or abnormality that contraindicates contact lens wear;
• Use of medications as specified in the protocol;
• Ocular surgery within the past 12 months;
• Other protocol-specified exclusion criteria may apply.

Related Conditions & MeSH terms

• Myopia
• Refractive Ametropia
• Refractive Errors

Intervention

Device:
• DACP FreshTech contact lenses
Nelfilcon A soft contact lenses with a modified lens design
• DACP contact lenses
Nelfilcon A soft contact lenses

Locations

Country	Name	City	State
United States	Alcon Investigative Site	Bloomington	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Distance Visual Acuity (VA) With Study Lenses	VA was assessed at a distance of 4 meters using a letter chart and was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.	Week 1, each product