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OpenTrials
Completed

NCT Number: NCT04532099

Clinical Comparison of Two Daily Wear Frequent Replacement Silicone Hydrogel Soft Contact Lenses

The primary objective of this study is to evaluate the overall performance of an investigational silicone hydrogel lens when compared to ACUVUE OASYS® with HYDRACLEAR® PLUS (AOHP).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alcon Investigator 6356, Longwood, Florida, United States

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About this study

Part A of this study is a randomized, double masked, crossover study comparing 2 contact lens products. The expected duration of subject participation in Part A is approximately 8 weeks with 5 scheduled visits.

Part B of this study is a non-randomized, single masked, single group study with 1 contact lens product. The expected duration of subject participation in Part B is approximately 4 weeks with 3 scheduled visits.

Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

  • Sign an approved Informed Consent Form.
  • Wear spherical contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
  • Willing to wear habitual spectacles for vision correction when study lenses are not worn, as needed.
  • Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

  • Any eye condition or use of medication that contraindicates contact lens wear, as determined by the Investigator.
  • History of refractive surgery or plan to have refractive surgery during the study.
  • Current or history of dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear.
  • Routinely sleeps in contact lenses at least 1 night per week.
  • Part A: Current wearer of ACUVUE OASYS® with HYDRACLEAR® PLUS.
  • Part B: Current wearer of Biofinity family of contact lenses (comfilcon A).
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Lehfilcon A contact lenses

Device

Investigational soft contact lenses for daily wear worn in Part A of the study

Other names: LID018869

Senofilcon A contact lenses

Device

Commercially available soft contact lenses for daily wear worn in Part A of the study

Other names: AOHP, ACUVUE OASYS® with HYDRACLEAR® PLUS

Comfilcon A contact lenses

Device

Commercially available soft contact lenses for daily wear worn in Part B of the study

Other names: CooperVision® Biofinity®

Hydrogen peroxide-based cleaning and disinfecting solution

Device

For nightly cleaning and disinfecting of contact lenses in Part A and Part B of the study

Other names: CLEAR CARE®

Primary outcomes

  1. Distance Visual Acuity (VA) (Part A)

    Time frame: Day 30, each study lens type

    Distance VA was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity. No formal hypothesis testing was predefined for the primary endpoint. The primary endpoint was prespecified for Part A only.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 31, 2020
Registry last updated
May 3, 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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