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Completed

NCT Number: NCT03920280

Clinical Evaluation of a Daily Wear Frequent Replacement Silicone Hydrogel Lens

The purpose of this clinical study is to demonstrate 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.

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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 Investigator 6565, Maitland, Florida, United States

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About this study

Subjects will be randomized to wear either the investigational contact lenses or the commercially available contact lenses in both eyes. Subjects will be expected to attend 6 scheduled study visits. Individual participation in the study will be 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 ≤ 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.
  • Monovision contact lens wearers.
  • Habitually wearing Biofinity® lenses.
  • Other protocol-specified exclusion criteria may apply.

Treatment and study plan

LID015385 contact lenses

Device

Investigational silicone hydrogel contact lenses

Comfilcon A soft contact lenses

Device

Commercially available silicone hydrogel contact lenses

Other names: Biofinity

CLEAR CARE

Device

Hydrogen peroxide-based cleaning and disinfecting system

Primary outcomes

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

    Time frame: Day 1 Dispense; Week 1 Follow-up; Week 2 Follow-up; Month 1 Follow-up; Month 2 Follow-up; Month 3 Follow-up/Exit (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 lower logMAR values indicating better visual acuity. No formal hypothesis testing was planned.

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

    Time frame: Day 1 Dispense; Week 1 Follow-up; Week 2 Follow-up; Month 1 Follow-up; Month 2 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 the logarithm minimum angle of resolution (logMAR) scale. A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. No formal hypothesis testing was planned.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 18, 2019
Registry last updated
Jul 28, 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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