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

Not Applicable

Completed

• Conditions: Refractive Errors; Myopia
• Interventions: Device: Verofilcon A contact lenses; Device: Nesofilcon A contact lenses

• Registration Number: NCT04527978
• Lead Sponsor: Alcon Research

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2020-08-24
• Study First Submitted QC: 2020-08-24
• Study First Posted: 2020-08-27
• Study Start: 2020-09-15
• Primary Completion: 2020-11-06
• Study Completion: 2020-11-06
• Status Verified: 2021-10
• Results First Submitted: 2021-10-27
• Results First Submitted QC: 2021-10-27
• Last Update Submitted: 2021-10-27
• Results First Posted: 2021-11-23
• Last Update Posted: 2021-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PRECISION1, then Biotrue ONEday	Verofilcon A contact lenses	Verofilcon A contact lenses worn first, with nesofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.
Biotrue ONEday, then PRECISION1	Verofilcon A contact lenses	Nesofilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.
Biotrue ONEday, then PRECISION1	Nesofilcon A contact lenses	Nesofilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.
PRECISION1, then Biotrue ONEday	Nesofilcon A contact lenses	Verofilcon A contact lenses worn first, with nesofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.

Primary Outcome Measures

Name	Time	Method
Distance Visual Acuity (VA) With Study Lenses	Day 8 (-0/+3 days) after 10 (-2/+6) hours of wear, each study lens type	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.

Trial Locations

Locations (4)

Alcon Investigator 6402; 🇺🇸 Medina, Minnesota, United States

Alcon Investigator 6565; 🇺🇸 Maitland, Florida, United States

Alcon Investigator 6313; 🇺🇸 Powell, Ohio, United States

Alcon Investigator 8028; 🇺🇸 Wichita Falls, Texas, United States