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

Not Applicable

Completed

Conditions: Refractive Errors
Ametropia

Interventions: Device: Comfilcon A contact lenses
Device: Lehfilcon A contact lenses
Device: Senofilcon A contact lenses
Device: Hydrogen peroxide-based cleaning and disinfecting solution

Registration Number: NCT04532099

Lead Sponsor: Alcon Research

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 132

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LID018869, then AOHP (Part A)	Hydrogen peroxide-based cleaning and disinfecting solution	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.
Biofinity (Part B)	Comfilcon A contact lenses	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.
LID018869, then AOHP (Part A)	Lehfilcon A contact lenses	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.
AOHP, then LID018869 (Part A)	Senofilcon A contact lenses	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.
Biofinity (Part B)	Hydrogen peroxide-based cleaning and disinfecting solution	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.
LID018869, then AOHP (Part A)	Senofilcon A contact lenses	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.
AOHP, then LID018869 (Part A)	Lehfilcon A contact lenses	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.
AOHP, then LID018869 (Part A)	Hydrogen peroxide-based cleaning and disinfecting solution	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.

Primary Outcome Measures

Name	Time	Method
Distance Visual Acuity (VA) (Part A)	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.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (4): Alcon Investigator 6353
🇺🇸
Memphis, Tennessee, United States
Alcon Investigator 6356
🇺🇸
Longwood, Florida, United States
Alcon Investigator 6565
🇺🇸
Maitland, Florida, United States
Alcon Investigator 6401
🇺🇸
Warwick, Rhode Island, United States