Two Daily Disposable Contact Lenses in Symptomatic Patients

Myopia Clinical Trial

Official title:

Two Daily Disposable Contact Lenses in Symptomatic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03628599
• Other study ID #: CLS312-P001
• Status: Completed
• Phase: N/A
• Start date: August 13, 2018
• Est. completion date: September 25, 2018

Study information

• Verified date: June 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 performance of DAILIES TOTAL1® and ACUVUE OASYS® 1-DAY and with respect to visual acuity in a symptomatic study population of monthly or bi-weekly replacement lens wearers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: September 25, 2018
• Est. primary completion date: September 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Able to understand and must sign an IRB-approved informed consent form;

• Soft contact lens wearers in both eyes during the past 3 months;

• Best-corrected visual acuity (BCVA) 20/25 or better in each eye;

• Willing to wear study lenses at least 3 days per week and at least 8 hours per day;

• Willing to stop wearing habitual contact lenses for the duration of study participation.

Exclusion Criteria:

• Infection, inflammation, abnormality, condition, disease, surgery, or use of medications, as specified in the protocol;

• Intolerance, hypersensitivity, or allergy to any component of the study products;

• 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).

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Delefilcon A contact lenses
Water Gradient silicon hydrogel daily disposable contact lenses
• Senofilcon A contact lenses
Silicon hydrogel daily disposable contact lenses with HydraLuxe™ Technology

Locations

Country	Name	City	State
United States	Alcon Investigative Site	Bloomington	Illinois
United States	Alcon Investigative Site	Pittsburg	Kansas
United States	Alcon Investigative Site	Powell	Ohio
United States	Alcon Investigative Site	Warwick	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Monocular Corrected Distance Visual Acuity (VA)	Monocular (each eye) corrected (with spectacles or other visual corrective devices) VA was performed under dimmed room illumination using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart at distance. VA was reported in logMAR ("logarithm of the minimum angle of resolution"), with a lower logMAR indicating better visual acuity. No inferential hypotheses was planned for this endpoint.	Week 4