Performance Assessment of a Modified Daily Disposable Contact Lens

Myopia Clinical Trial

Official title:

Performance Assessment of a Modified Daily Disposable Contact Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03762668
• Other study ID #: CLP691-C002
• Status: Completed
• Phase: N/A
• Start date: December 3, 2018
• Est. completion date: January 7, 2019

Study information

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

Clinical Trial Summary

The purpose of this study is to compare visual acuity between two daily disposable contact lenses.

Description:

The expected duration of subject participation in the study is approximately 2 weeks, with 3 scheduled visits.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: January 7, 2019
• Est. primary completion date: January 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Able to understand and sign an approved Informed Consent form;

• Current wearer of commercial DAILIES TOTAL1 Contact Lenses in both eyes;

• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Any eye condition that contraindicates contact lens wear, as determined by the Investigator;

• Any eye surgery that contraindicates contact lens wear, as determined by the Investigator;

• Wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week)

• Monocular (only one eye with functional vision);

• Other protocol-specified exclusion criteria may apply.

Related Conditions & MeSH terms

• Hyperopia
• Myopia
• Refractive Errors

Intervention

Device:
• Modified delefilcon A contact lenses
Spherical soft daily disposable contact lens
• Delefilcon A contact lenses
Spherical soft daily disposable contact lens

Locations

Country	Name	City	State
United States	Alcon Investigative Site	Ann Arbor	Michigan
United States	Alcon Investigative Site	Maitland	Florida
United States	Alcon Investigative Site	Memphis	Tennessee
United States	Alcon Investigative Site	Orlando	Florida
United States	Alcon Investigative Site	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	High Contrast Distance Visual Acuity (logMAR)	Distance visual acuity (VA) testing was performed using letter charts. Each row of the chart contained 5 letters, with the letters on each row progressively smaller than the row above. The subject read the letters from larger to smaller. The test terminated when the subject either misidentified a majority of letters on 1 row or progressed to the smallest row of letters. Visual acuity scoring sheets were used to record the number of letters correctly read. LogMAR VA was calculated based on the total number of letters read incorrectly as follows: LogMAR Acuity = base reading + (0.02 x number of letters missed). A lower logMAR value indicates better VA.	Day 1 Dispense, Day 7 Follow-Up