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OpenTrials
Completed

NCT Number: NCT05050578

Clinical Assessment of Two Reusable Silicone Hydrogel Contact Lenses

The purpose of this study is to compare the clinical performance of LID018869 soft contact with ACUVUE® OASYS with HYDRACLEAR® PLUS (AOHP) soft contact lenses over 30 days of daily wear.

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Key information

Conditions

Refractive Errors Eye Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Elsa Pao, OD, Oakland, California, United States

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About this study

Subjects will be expected to attend 6 visits. Subjects will be expected to wear their study contact lenses every day for at least 10 hours per day over a 30-day period for each study lens type. The total duration of a subject's participation in the study will be approximately 65 days.

Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

  • Current wearer of a commercial spherical weekly/monthly soft contact lenses with at least 3 months of wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day.
  • Manifest cylinder less than or equal to 0.75 diopter in each eye.
  • Best corrected distance visual acuity better than or equal to 20/25 Snellen in each eye.
  • Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

  • Monovision or multifocal lens wearer.
  • Habitual senofilcon contact lens wearer (for example, Acuvue Oasys, Acuvue Vita) or commercially available lehfilcon A contact lens wearer (TOTAL30).
  • Routinely sleeps in habitual contact lenses.
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Lehfilcon A contact lenses

Device

Commercially available, silicone hydrogel, spherical contact lenses used as indicated

Other names: LID018869

Senofilcon A contact lenses

Device

Commercially available, silicone hydrogel, spherical contact lenses used as indicated

Other names: AOHP

CLEAR CARE

Device

Hydrogen peroxide-based contact lens cleaning and disinfecting solution

Primary outcomes

  1. Least Squares Mean Distance Visual Acuity With Study Lenses at Day 30

    Time frame: Day 30, each study lens type

    Visual acuity (VA) was collected for each eye individually with study lenses in place at a distance of 4 meters using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 20, 2021
Registry last updated
Mar 16, 2023

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

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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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