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Completed

NCT Number: NCT04527978

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

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

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Key information

Conditions

Refractive Errors Eye Diseases Myopia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alcon Investigator 6565, Maitland, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Verofilcon A contact lenses

Device

Spherical soft contact lenses for daily disposable wear

Other names: PRECISION1™

Nesofilcon A contact lenses

Device

Spherical soft contact lenses for daily disposable wear

Other names: Biotrue ONEday, Bausch + Lomb Biotrue® ONEday

Primary outcomes

  1. Distance Visual Acuity (VA) With Study Lenses

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 27, 2020
Registry last updated
Nov 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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