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Completed

NCT Number: NCT04207749

Clinical Evaluation of a Daily Wear Silicone Hydrogel Lens

The purpose of this clinical study is to assess the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in a daily wear modality with frequent replacement.

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Key information

Conditions

Refractive Errors Eye Diseases Hyperopia Myopia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alcon Investigator 8103, Glendale, Arizona, United States

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About this study

Subjects will attend 4 office visits: Screening/Baseline/Dispense; Week 1 Follow-up; Month 1 Follow-up; and Month 3 Follow-up/Exit. The total expected duration of participation for each subject is approximately 3 months.

Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

  • Understand and sign an IRB/IEC approved Informed Consent form.
  • Willing and able to attend all scheduled study visits and wear the assigned study lenses as required per protocol.
  • Successful wear of frequent replacement, spherical, daily wear soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day.
  • Manifest cylinder ≤ 0.75 diopter (D) in each eye.
  • Best spectacle corrected visual acuity 20/20 or better in each eye.
  • Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

  • Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.
  • Monovision contact lens wear.
  • Any habitual wear of Biofinity lenses.
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

LID015385 contact lenses

Device

Investigational soft contact lenses

Comfilcon A contact lenses

Device

Commercially available soft contact lenses

Other names: BIOFINITY®

CLEAR CARE

Device

Hydrogen peroxide-based cleaning and disinfecting solution

Primary outcomes

  1. Least Squares Mean Contact Lens Corrected Distance Visual Acuity (CLCDVA) in Each Eye (CLL949-C018 + CLL949-C009)

    Time frame: Week 1 Follow-Up

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

Secondary outcomes

  1. Percentage of Subjects Achieving CLCDVA 20/20 or Better in Each Eye (CLL949-C018 + CLL949-C009)

    Time frame: Week 1 Follow-Up, at least 4 hours after lens insertion

    Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen, with 20/20 Snellen visual acuity considered normal distance eyesight.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 23, 2019
Registry last updated
Feb 2, 2022

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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