Clinical Comparison of Two Daily Disposable Contact Lenses - Pilot Study 3

Alcon Research4 sites in 1 country60 target enrollmentJuly 20, 2021

ConditionsMyopia Ametropia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Myopia
Sponsor: Alcon Research
Enrollment: 60
Locations: 4
Primary Endpoint: Distance VA (logMAR) With Study Lenses
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the overall performance of PRECISION1™ contact lenses when compared to INFUSE™ contact lenses.

Detailed Description

The expected duration of subject participation in the study is up to 24 days with 3 scheduled visits.

Registry

clinicaltrials.gov

Start Date

July 20, 2021

End Date

September 9, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Alcon Research

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Able to understand and sign an Informed Consent Form that been approved by an Institutional Review Board.
•Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
•Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

•Current/previous PRECISION1 or INFUSE contact lens wearer.
•Any eye condition or use of medication that contraindicates contact lens wear, as determined by the investigator.
•Routinely sleeps in contact lenses.
•Other protocol-defined exclusion criteria may apply.

Outcomes

Primary Outcomes

Distance VA (logMAR) With Study Lenses

Time Frame: Day 8 (-0/+3 days), each study lens type

Distance visual acuity (VA) was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity. No inferential testing was pre-specified for this endpoint.