Pilot Clinical Performance of a Silicone Hydrogel Lens for Up to Six Nights of Extended Wear

The purpose of this clinical study is to evaluate the on-eye performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn continuously for up to 1 week.

Study Overview

• Status: Completed
• Conditions: Refractive Errors; Myopia; Hyperopia
• Intervention / Treatment: Device: Comfilcon A contact lens; Device: Lehfilcon A contact lens

Detailed Description

Subjects will be randomized to wear the investigational contact lens in 1 eye and the commercially available contact lens in the other eye. Subjects will be expected to attend 3 scheduled study visits: Day 1 Screening/Baseline/Dispense; Day 2 Follow-up within 4 hours of awakening (after the first night of sleeping); and Week 1 Follow-up/Exit. The expected duration of exposure to each of the study lenses for all randomized, completed subjects was approximately 7 days / 6 nights of wear.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Medina, Minnesota, United States, 55340
      • Alcon Investigator 6402
  • Ohio
    • Granville, Ohio, United States, 43023
      • Alcon Investigator 8046
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Alcon Investigator 2786

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• Able to understand and sign an IRB/IEC approved Informed Consent form.
• Successful wear of spherical soft contact lenses in both eyes during the past 3 months for a minimum of 5 days/week and in an extended wear modality at least 1 night/week.
• Best corrected visual acuity of 20/25 or better in each eye.
• Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

• Any condition, use of medications, or surgery that could contraindicate contact lens wear, as determined by the Investigator.
• Any habitual wear of Biofinity contact lenses.
• Pregnant or breast-feeding.
• Other protocol specified exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LID018869 (OD) / Biofinity (OS); Lehfilcon A contact lens worn in the right eye, with comfilcon A contact lens worn in the left eye, as randomized, for approximately 1 week of continuous wear	Device: Comfilcon A contact lens; Commercially available silicone hydrogel contact lens; Other Names: Biofinity; Device: Lehfilcon A contact lens; Investigational silicone hydrogel contact lens; Other Names: LID018869
Active Comparator: Biofinity (OD) / LID018869 (OS); Comfilcon A contact lens worn in the right eye, with lehfilcon A contact lens worn in the left eye, as randomized, for approximately 1 week of continuous wear	Device: Comfilcon A contact lens; Commercially available silicone hydrogel contact lens; Other Names: Biofinity; Device: Lehfilcon A contact lens; Investigational silicone hydrogel contact lens; Other Names: LID018869

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distance Visual Acuity (VA) With Study Lenses	Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). 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.	Day 1 Dispense; Day 2 Follow-up (within 4 hours of awakening); Week 1 Follow-up/Exit

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: CDMA Project Lead, Vision Care, Alcon Research, LLC

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2020
• Primary Completion (Actual): August 31, 2020
• Study Completion (Actual): August 31, 2020

Study Registration Dates

• First Submitted: May 21, 2020
• First Submitted That Met QC Criteria: May 21, 2020
• First Posted (Actual): May 27, 2020

Study Record Updates

• Last Update Posted (Actual): August 22, 2023
• Last Update Submitted That Met QC Criteria: August 18, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Contact Lens; Vision Correction; Extended Wear; Overnight Wear; Contralateral Wear
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Hyperopia
• Other Study ID Numbers: CLY935-C008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes