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Completed

NCT Number: NCT03560141

Clinical Performance of a Silicone Hydrogel Contact Lens Following One Night of Extended Wear

The purpose of this clinical study is to evaluate the on-eye performance of an investigational soft contact lens compared to a commercially available soft contact lens following 1 night of extended 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

Alcon Investigative Site

Johns Creek, Georgia, 30097, United States

About this study

Subjects will be randomized to wear the investigational contact lens in 1 eye and the commercially available contact lens in the other eye. Subjects will be expected to attend 4 scheduled study visits. The lenses will be worn continuously from the time of dispense on Day 1 until lens collection at the Day 2 Follow-up/Exit Visit.

Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

  • Able to understand and sign an approved Informed Consent form.
  • Successful wear of spherical soft contact lenses in both eyes during the past 3 months for a minimum of 5 days per week in either a daily wear or extended wear modality.
  • Best Corrected Visual Acuity (BCVA) of 20/25 or better in each eye.
  • Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

  • Any condition, use of medications, or surgery that could contraindicate contact lens wear, as determined by the Investigator.
  • Current Biofinity® lens wearer.
  • Pregnant or breast-feeding.
  • Other protocol-specified exclusion criteria may apply.

Treatment and study plan

LID011121 contact lens

Device

Investigational silicone hydrogel contact lens

Comfilcon A contact lens

Device

Commercially available silicone hydrogel contact lens

Other names: Biofinity

Primary outcomes

  1. Visual Acuity (VA) With Study Lenses, Collected by Eye

    Time frame: Day 1 Dispense; Day 1 Follow-up Prior to Sleeping; Day 2 Follow-up Upon Eye Opening; Day 2 Follow-up Approximately 1 Hour after Awakening/Exit

    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

Official study title

Clinical Performance of a Silicone Hydrogel Following One Night of Extended Wear

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 18, 2018
Registry last updated
Jul 28, 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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