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OpenTrials
Completed

NCT Number: NCT04178720

Clinical Evaluation of a Daily Wear Monthly Replacement Silicone Hydrogel Lens

The purpose of this clinical study is to evaluate the safety and effectiveness of an investigational soft contact lens compared to a commercially available soft contact lens when worn for daily wear and replaced monthly.

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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

Alcon Investigative Site, Longwood, Florida, United States

Loading trial locations.

About this study

Subjects are expected to attend 6 study visits. The expected duration of study lens exposure 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:

  • Successful wear of spherical daily wear frequent replacement 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 equal to or less than 0.75 diopter (D) in each eye.
  • Other protocol-specified 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.
  • Habitually wearing Biofinity contact lenses.
  • Monovision contact lens wearers.
  • Other protocol-specified exclusion criteria may apply.

Treatment and study plan

Lehfilcon A contact lenses

Device

Investigational silicone hydrogel contact lenses

Other names: LID018869

Comfilcon A contact lenses

Device

Commercially available silicone hydrogel contact lenses

Other names: CooperVision® BIOFINITY®, Biofinity

CLEAR CARE

Device

Hydrogen peroxide-based system for cleaning and disinfecting silicone hydrogel contact lenses

Other names: CLEAR CARE® Cleaning & Disinfecting Solution

Primary outcomes

  1. Distance VA (logMAR) With Study Lenses - Completed Eyes

    Time frame: Dispense, Week 1 follow-up, Week 2 follow-up, Month 1 follow-up, Month 2 follow-up, Month 3 follow-up (at least 4 hours after lens insertion at each follow-up assessment visit)

    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 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 a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.

  2. Distance VA (logMAR) With Study Lenses - Discontinued Eyes

    Time frame: Dispense, Week 1 follow-up, Week 2 follow-up, Month 1 follow-up

    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 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 a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 26, 2019
Registry last updated
Oct 19, 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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