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OpenTrials
Completed

NCT Number: NCT04403542

Pilot Clinical Performance of a Silicone Hydrogel Lens for Up to Six Nights 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 when worn continuously for up to 1 week.

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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 6402, Medina, Minnesota, United States

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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 3 scheduled study visits: Day 1 Screening/Baseline/Dispense; Day 2 Follow-up within 4 hours of awakening (after the first night of sleeping); and Week 1 Follow-up/Exit. The expected duration of exposure to each of the study lenses for all randomized, completed subjects was approximately 7 days / 6 nights of wear.

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 IRB/IEC 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/week and in an extended wear modality at least 1 night/week.
  • Best corrected visual acuity 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.
  • Any habitual wear of Biofinity contact lenses.
  • Pregnant or breast-feeding.
  • Other protocol specified exclusion criteria may apply.

Treatment and study plan

Lehfilcon A contact lens

Device

Investigational silicone hydrogel contact lens

Other names: LID018869

Comfilcon A contact lens

Device

Commercially available silicone hydrogel contact lens

Other names: Biofinity

Primary outcomes

  1. Distance Visual Acuity (VA) With Study Lenses

    Time frame: Day 1 Dispense; Day 2 Follow-up (within 4 hours of awakening); Week 1 Follow-up/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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 27, 2020
Registry last updated
Aug 22, 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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