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OpenTrials
Completed

NCT Number: NCT05766787

The Clinical Performance of Two Reusable Silicone Hydrogel Contact Lenses

The purpose of this study is to assess the clinical performance of two reusable silicone hydrogel contact lenses when worn on a daily wear basis.

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Key information

Conditions

Refractive Ametropia Eye Diseases Myopia Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kurata Eyecare Center, Los Angeles, California, United States

Loading trial locations.

About this study

In this crossover study, subjects will wear each lens product for approximately 14 days and attend 7 scheduled visits. The expected overall duration of exposure to the study products is approximately 28 days.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months.
  • Best Corrected Visual Acuity (BCVA) of 20/25 Snellen (0.10 logMAR) or better in each eye.
  • Willing to stop wearing habitual contact lenses for the duration of study participation.
  • Other protocol-specific inclusion criteria may apply.

Exclusion criteria

  • Any eye infection, inflammation, abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the investigator.
  • Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator.
  • Habitual wear of AOHP contact lenses.
  • Habitual wear of any daily disposable contact lenses.
  • Other protocol-specified exclusion criteria may apply.

Treatment and study plan

Serafilcon A contact lenses

Device

Reusable silicone hydrogel contact lenses worn during the day and removed at night for cleaning and disinfection

Other names: LID022821

Senofilcon A contact lenses

Device

Reusable silicone hydrogel contact lenses worn during the day and removed at night for cleaning and disinfection

Other names: ACUVUE OASYS® with HYDRACLEAR® PLUS Technology, AOHP

CLEAR CARE

Device

Hydrogen peroxide based contact lens cleaning and disinfecting solution

Other names: CLEAR CARE® Cleaning and Disinfecting Solution

Primary outcomes

  1. Least Squares Mean Distance VA With Study Lenses at Week 1

    Time frame: Week 1 of each lens product worn during the corresponding crossover period

    Visual acuity (VA) was assessed for each eye individually with study lenses in place using logarithmic of the Minimum Angle of Resolution (logMAR) reading charts. LogMAR values typically range from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal distance visual acuity), with a negative value denoting better than 20/20 visual acuity.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 13, 2023
Registry last updated
Jun 13, 2024

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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