Clinical Characterization of an Investigational Soft Silicone Hydrogel Contact Lens

The primary objective of this study is to evaluate the overall clinical performance of an investigational silicone hydrogel contact lens over 2 weeks of daily wear.

Study Overview

• Status: Completed
• Conditions: Refractive Errors
• Intervention / Treatment: Device: Lehfilcon A contact lenses; Device: Multipurpose disinfection solution

Detailed Description

Participants will attend a Screening visit, a Dispense visit (0 to 4 days later), and a follow-up visit approximately 2 weeks after the Dispense visit.

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

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32803
      • Alcon Investigative Site
  • Illinois
    • Bloomington, Illinois, United States, 61704
      • Alcon Investigative Site
  • Ohio
    • Powell, Ohio, United States, 43065
      • 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

Inclusion Criteria:

• Understand and sign an Informed Consent that has been approved by an Institutional Review Board.
• Successful wear of spherical weekly/monthly soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months.
• Willing to stop wearing habitual contact lenses for the duration of study participation.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Any condition that contraindicates contact lens wear, as determined by the Investigator.
• Any use of systemic or ocular medications 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.
• Habitual contact lenses worn in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.
• Any use of topical ocular medications or artificial tear or rewetting drops that would require instillation during contact lens wear.
• Monovision or multifocal contact lens wear.
• Other protocol-defined exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: LID020098; Lehfilcon A contact lenses worn in both eyes for 2 weeks. Lenses will be removed nightly for cleaning and disinfection.	Device: Lehfilcon A contact lenses; Silicone hydrogel contact lenses with investigational coating; Other Names: LID020098; Device: Multipurpose disinfection solution; Solution for cleaning, disinfecting, and reconditioning silicone hydrogel contact lenses; Other Names: OPTI-FREE® RepleniSH®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Front Surface Wettability, by Category	Front surface wettability (i.e., assessment of the disruption of the front surface wettability of the contact lens) was assessed by the investigator for each eye individually. Front surface wettability was collected on a 5-point scale, where where Grade 0 = a smooth uniformly reflecting surface and Grade 4 = non-wettable lens surface. No formal hypothesis was predefined for the primary endpoint. No inferential testing was performed.	Dispense; Week 2 Follow-up

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Sr. Clinical Trial Lead, CDMA Vision Care, Alcon Research

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 3, 2020
• Primary Completion (ACTUAL): December 31, 2020
• Study Completion (ACTUAL): December 31, 2020

Study Registration Dates

• First Submitted: November 11, 2020
• First Submitted That Met QC Criteria: November 11, 2020
• First Posted (ACTUAL): November 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 12, 2022
• Last Update Submitted That Met QC Criteria: December 15, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Vision; Contact lenses
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: CLY935-E006

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