Clinical Assessment of a Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lens

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: Lehfilcon A contact lenses; Device: Comfilcon A contact lenses; Device: CLEAR CARE

• Registration Number: NCT04476784
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to assess the clinical performance of an investigational contact lens over 30 days of daily wear.

Detailed Description

Subjects will wear two products and be expected to attend 4 office visits. The individual duration of participation will be approximately 60 days (30 days for each product).

Study Timeline

• Study First Submitted: 2020-07-15
• Study First Submitted QC: 2020-07-15
• Study First Posted: 2020-07-20
• Study Start: 2020-08-17
• Primary Completion: 2020-11-18
• Study Completion: 2020-11-18
• Status Verified: 2021-09
• Results First Submitted: 2021-09-29
• Results First Submitted QC: 2021-09-29
• Last Update Submitted: 2021-09-29
• Results First Posted: 2021-10-26
• Last Update Posted: 2021-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• Able to understand and sign an approved Informed Consent form;
• Willing and able to attend all scheduled study visits as required by the protocol;
• Current wearer of spherical weekly/monthly soft contact lenses in both eyes with at least 3 months wearing time of 5 days per week and 10 hours per day;
• Other protocol-defined inclusion criteria may apply.

Key

Exclusion Criteria

• Current or prior Biofinity contact lens wearer in the past 3 months;
• Monovision contact lens wearer;
• Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LID018869, then Biofinity	Comfilcon A contact lenses	Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses, as randomized. Each product will be worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE will be used for nightly cleaning and disinfection.
Biofinity, then LID018869	Comfilcon A contact lenses	Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product will be worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE will be used for nightly cleaning and disinfection.
Biofinity, then LID018869	CLEAR CARE	Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product will be worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE will be used for nightly cleaning and disinfection.
LID018869, then Biofinity	Lehfilcon A contact lenses	Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses, as randomized. Each product will be worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE will be used for nightly cleaning and disinfection.
LID018869, then Biofinity	CLEAR CARE	Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses, as randomized. Each product will be worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE will be used for nightly cleaning and disinfection.
Biofinity, then LID018869	Lehfilcon A contact lenses	Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product will be worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE will be used for nightly cleaning and disinfection.

Primary Outcome Measures

Name	Time	Method
Mean Distance Visual Acuity (logMAR) With Study Lenses	Day 1, Day 30 after 6-8 hours of wear, each product	Visual acuity (VA) was collected for each eye individually with study lenses in place at a distance of 4 meters using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). On Day 30, VA was assessed after 6-8 hours of wear. A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.

Trial Locations

Locations (1)

Alcon Investigative Site; 🇺🇸 Memphis, Tennessee, United States