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OpenTrials
Completed

NCT Number: NCT03586167

Clinical Performance of a Monthly Replacement Silicone Hydrogel Lens

The purpose of this study is to assess the clinical performance of an investigational, coated silicone hydrogel contact lens over approximately 30 days of daily 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, Maitland, Florida, United States

Loading trial locations.

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 approved by an Institutional review board (IRB);
  • Successful wear of spherical monthly replacement soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
  • Best-corrected visual acuity (BCVA) 20/25 or better in each eye;
  • Willing to stop wearing habitual contact lenses for the duration of study participation.

Exclusion criteria

  • Any conditions or use of medications that could contraindicate contact lens wear;
  • History of or plan to have refractive surgery in either eye;
  • Irregular cornea in either eye;
  • Ocular or intraocular surgery (excluding placement of punctal plugs) within the previous 12 months or planned during the study;
  • Current or history of intolerance, hypersensitivity or allergy to any component of the study products;
  • 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;
  • Use of topical ocular medications and artificial tear or rewetting drops requiring instillation during contact lens wear;
  • Habitual Biofinity contact lens wearers.

Treatment and study plan

LID014341 contact lenses

Device

Investigational monthly replacement silicone hydrogel contact lenses with water gradient coating

Comfilcon A contact lenses

Device

Silicone hydrogel contact lenses

Other names: BIOFINITY©

Primary outcomes

  1. Distance Visual Acuity (VA)

    Time frame: Day 30

    VA was tested monocularly (each eye individually) without visual correction under photopic (well-lit) conditions. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. A lower numeric value represents better visual acuity. Both eyes contributed to the analysis. No formal statistical hypothesis testing was planned.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 13, 2018
Registry last updated
Jun 30, 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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