Clinical Performance of a Silicone Hydrogel Contact Lens Following Six Nights of Extended Wear

Clinical Performance of a Silicone Hydrogel Following 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 following 1 week of extended wear.

Study Overview

• Status: Completed
• Conditions: Refractive Errors
• Intervention / Treatment: Device: LID011121 contact lens; Device: Comfilcon 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 Baseline/Dispense; Day 2 Follow-up; 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): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Johns Creek, Georgia, United States, 30097
      • Alcon Investigative Site
  • Tennessee
    • Brentwood, Tennessee, United States, 37027
      • Alcon Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key Inclusion Criteria:

• Able to understand and sign an Institutional Review Board/Ethics Committee-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 per week and in an extended wear modality a minimum of 1 night per week.
• Best Corrected Visual Acuity (BCVA) 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.
• Current Biofinity© lens wearer.
• 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: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: LID011121 (OD) / Biofinity (OS); LID011121 contact lens worn in the right eye, with comfilcon A contact lens worn in the left eye, as randomized, for approximately 6 nights of extended (overnight) wear	Device: LID011121 contact lens; Investigational silicone hydrogel contact lens; Device: Comfilcon A contact lens; Commercially available silicone hydrogel contact lens; Other Names: Biofinity
Other: Biofinity (OD) / LID011121 (OS); Comfilcon A contact lens worn in the right eye, with LID011121 contact lens worn in the left eye, as randomized, for approximately 6 nights of extended (overnight) wear	Device: LID011121 contact lens; Investigational silicone hydrogel contact lens; Device: Comfilcon A contact lens; Commercially available silicone hydrogel contact lens; Other Names: Biofinity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity (VA) With Study Lenses, Collected by Eye	Visual acuity (VA) was assessed for each eye individually with study lenses in place 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 (ideally 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 23, 2018
• Primary Completion (Actual): September 11, 2018
• Study Completion (Actual): September 11, 2018

Study Registration Dates

• First Submitted: July 30, 2018
• First Submitted That Met QC Criteria: July 30, 2018
• First Posted (Actual): August 3, 2018

Study Record Updates

• Last Update Posted (Actual): September 30, 2021
• Last Update Submitted That Met QC Criteria: September 2, 2021
• Last Verified: September 1, 2021

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
• Other Study ID Numbers: CLL949-C005

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