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Completed

NCT Number: NCT04085328

Assessment of an Investigational Frequent Replacement Silicone Hydrogel Lens

The purpose of this clinical trial is to evaluate the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in an extended wear modality.

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Key information

Conditions

Refractive Ametropia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Family EyeCare Center, Campbell, California, United States

Loading trial locations.

About this study

Subjects will be expected to attend 9 office visits. The total expected duration of participation for each subject is approximately 12 months.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Able to understand and sign an Informed Consent Form.
  • Willing to attend all scheduled study visits as required per protocol.
  • Willing and able to wear assigned study lenses as required per protocol.
  • Successful wear of spherical daily wear or extended wear frequent replacement soft contact lenses in both eyes during the past 3 months for a minimum of 5 days per week.
  • Manifest cylinder ≤ 0.75 diopter (D) in each eye.
  • Other protocol-specified inclusion criteria may apply.

Exclusion criteria

  • Any eye infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator.
  • Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator.
  • History of eye surgery, including refractive surgery.
  • Currently pregnant or breast-feeding.
  • Monovision contact lens wearers.
  • Daily disposable contact lens wearers.
  • Other protocol-specified exclusion criteria may apply.

Treatment and study plan

LID015385 soft contact lenses

Device

Investigational silicone hydrogel contact lenses for up to 6 nights/7 days of continuous wear

Comfilcon A soft contact lenses

Device

Silicone hydrogel contact lenses for up to 6 nights/7 days of continuous wear

Other names: BIOFINITY®

Primary outcomes

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

    Time frame: Day 1 Dispense; Hour 24 Follow-Up; Week 1 Follow-up; Month 1 Follow-up; Month 2 Follow-up; Month 3 Follow-up; Month 6 Follow-up; Month 9 Follow-up, Month 12 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 lower logMAR values indicating better visual acuity. No formal hypothesis was formulated for the primary effectiveness endpoint of distance VA; hence, no inferential testing was performed.

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

    Time frame: Day 1 Dispense; Hour 24 Follow-Up; Week 1 Follow-up; Month 1 Follow-up; Month 2 Follow-up; Month 3 Follow-up; Month 6 Follow-up; Month 9 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 lower logMAR values indicating better visual acuity. No formal hypothesis was formulated for the primary effectiveness endpoint of distance VA; hence, no inferential testing was performed.

  3. Proportion of Ocular Serious and Significant Non-serious Adverse Device Effects (ADEs)

    Time frame: Up to Month 12

    Calculated as the total number of eyes reporting at least one treatment-emergent, ocular, serious ADE or treatment-emergent, ocular, significant, non-serious ADE, divided by the total number of eyes enrolled and dispensed. An ADE was defined as any adverse event related to the use of the investigational medical device (LID015385) or control product (Biofinity).

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Clinical Safety and Effectiveness Assessment of an Investigational Frequent Replacement Silicone Hydrogel Lens

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 11, 2019
Registry last updated
Jun 13, 2023

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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