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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04527978
• Other study ID #: CLE383-P003
• Status: Completed
• Phase: N/A
• Start date: September 15, 2020
• Est. completion date: November 6, 2020

Study information

• Verified date: October 2021
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: November 6, 2020
• Est. primary completion date: November 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Myopia
• Refractive Errors

Intervention

Device:
• Verofilcon A contact lenses
Spherical soft contact lenses for daily disposable wear
• Nesofilcon A contact lenses
Spherical soft contact lenses for daily disposable wear

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 8 (-0/+3 days) after 10 (-2/+6) hours of wear, each study lens type