Clinical Comparison of 2 Daily Disposable Contact Lenses - Pilot Study 1

Alcon Research56 enrolled

Overview

The primary objective of this study is to evaluate the overall performance of PRECISION1 contact lenses when compared to Biotrue ONEday contact lenses.

Subjects are expected to attend 3 study visits and wear the PRECISION1 and Biotrue ONEday study lenses in a crossover design for approximately 8 days of exposure to each study lens type. The expected duration of subject participation is up to 22 days.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Refractive Errors Myopia

Interventions

Verofilcon A contact lensesDEVICE

Spherical soft contact lenses for daily disposable wear

Nesofilcon A contact lensesDEVICE

Spherical soft contact lenses for daily disposable wear

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Subject must be able to understand and must sign an Institution Review Board (IRB) approved Informed Consent Form. * 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. * Willing to wear contact lenses for at least 16 hours per day on one of the days with each lens type. * Other protocol-specified inclusion criteria may apply. Key Exclusion Criteria: * Any ocular condition that contraindicates contact lens wear. * Previous or current habitual wearer of PRECISION1, Biotrue ONEday, or DAILIES TOTAL1 contact lenses. * Other protocol-specified exclusion criteria may apply.

Locations (4)

Alcon Investigator 6565

Maitland, Florida, United States

Alcon Investigator 6402

Medina, Minnesota, United States

Alcon Investigator 6313

Powell, Ohio, United States

Alcon Investigator 8028

Wichita Falls, Texas, United States

Outcomes

Primary Outcomes

Distance Visual Acuity (VA) With Study Lenses

Distance 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 formal hypothesis was predefined for the primary endpoint. No inferential testing was performed.

Time frame: Day 8 (-0/+3 days) after 10 (-2/+6) hours of wear, each study lens type

Data from ClinicalTrials.gov

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