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

NCT ID: NCT04532099

Last Updated: 2022-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-09
• Study Completion Date: 2021-05-04

Brief Summary

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).

Detailed Description

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.

Conditions

Refractive Errors; Ametropia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

LID018869, then AOHP (Part A)

Lehfilcon A contact lenses worn first, followed by senofilcon A contact lenses, as randomized. Each product will be worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of each wear period. Lenses will be removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution.

Group Type: OTHER

Lehfilcon A contact lenses

Intervention Type: DEVICE

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

Senofilcon A contact lenses

Intervention Type: DEVICE

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

Hydrogen peroxide-based cleaning and disinfecting solution

Intervention Type: DEVICE

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

AOHP, then LID018869 (Part A)

Senofilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product will be worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of each wear period. Lenses will be removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution.

Group Type: OTHER

Lehfilcon A contact lenses

Intervention Type: DEVICE

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

Senofilcon A contact lenses

Intervention Type: DEVICE

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

Hydrogen peroxide-based cleaning and disinfecting solution

Intervention Type: DEVICE

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

Biofinity (Part B)

Comfilcon A contact lenses worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of the wear period. Lenses will be removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution.

Group Type: ACTIVE_COMPARATOR

Comfilcon A contact lenses

Intervention Type: DEVICE

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

Hydrogen peroxide-based cleaning and disinfecting solution

Intervention Type: DEVICE

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

Interventions

Lehfilcon A contact lenses

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

Intervention Type: DEVICE

Senofilcon A contact lenses

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

Intervention Type: DEVICE

Comfilcon A contact lenses

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

Intervention Type: DEVICE

Hydrogen peroxide-based cleaning and disinfecting solution

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

Intervention Type: DEVICE

Other Intervention Names

LID018869; AOHP; ACUVUE OASYS® with HYDRACLEAR® PLUS; CooperVision® Biofinity®; CLEAR CARE®

Eligibility Criteria

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.

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sr. Clinical Trial Lead, CDMA Vision Care

Role: STUDY_DIRECTOR

Alcon Research, LLC

Locations

Alcon Investigator 6356

Longwood, Florida, United States

Alcon Investigator 6565

Maitland, Florida, United States

Alcon Investigator 6401

Warwick, Rhode Island, United States

Alcon Investigator 6353

Memphis, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CLY935-C020

Identifier Type: -

Identifier Source: org_study_id