search
Back to results

Clinical Evaluation of a Daily Wear Monthly Replacement Silicone Hydrogel Lens

Primary Purpose

Refractive Errors

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lehfilcon A contact lenses
Comfilcon A contact lenses
CLEAR CARE
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractive Errors focused on measuring Contact Lens, Daily Wear, Vision Correction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Successful wear of spherical daily wear frequent replacement soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day.
  • Manifest cylinder equal to or less than 0.75 diopter (D) in each eye.
  • Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

  • Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.
  • Habitually wearing Biofinity contact lenses.
  • Monovision contact lens wearers.
  • Other protocol-specified exclusion criteria may apply.

Sites / Locations

  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LID018869

Biofinity

Arm Description

Lehfilcon A contact lenses worn in both eyes at least approximately 8 hours per day and approximately 5 days per week during waking hours only. The lenses will be removed nightly for cleaning and disinfection and replaced monthly over the 3-month wear period.

Comfilcon A contact lenses worn in both eyes at least approximately 8 hours per day and approximately 5 days per week during waking hours only. The lenses will be removed nightly for cleaning and disinfection and replaced monthly over the 3-month wear period.

Outcomes

Primary Outcome Measures

Distance VA (logMAR) With Study Lenses - Completed Eyes
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.
Distance VA (logMAR) With Study Lenses - Discontinued Eyes
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.

Secondary Outcome Measures

Full Information

First Posted
November 25, 2019
Last Updated
September 29, 2021
Sponsor
Alcon Research
search

1. Study Identification

Unique Protocol Identification Number
NCT04178720
Brief Title
Clinical Evaluation of a Daily Wear Monthly Replacement Silicone Hydrogel Lens
Official Title
Clinical Evaluation of a Daily Wear Monthly Replacement Silicone Hydrogel Lens
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
January 28, 2020 (Actual)
Primary Completion Date
June 10, 2020 (Actual)
Study Completion Date
June 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this clinical study is to evaluate the safety and effectiveness of an investigational soft contact lens compared to a commercially available soft contact lens when worn for daily wear and replaced monthly.
Detailed Description
Subjects are expected to attend 6 study visits. The expected duration of study lens exposure is approximately 3 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Errors
Keywords
Contact Lens, Daily Wear, Vision Correction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
119 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LID018869
Arm Type
Experimental
Arm Description
Lehfilcon A contact lenses worn in both eyes at least approximately 8 hours per day and approximately 5 days per week during waking hours only. The lenses will be removed nightly for cleaning and disinfection and replaced monthly over the 3-month wear period.
Arm Title
Biofinity
Arm Type
Active Comparator
Arm Description
Comfilcon A contact lenses worn in both eyes at least approximately 8 hours per day and approximately 5 days per week during waking hours only. The lenses will be removed nightly for cleaning and disinfection and replaced monthly over the 3-month wear period.
Intervention Type
Device
Intervention Name(s)
Lehfilcon A contact lenses
Other Intervention Name(s)
LID018869
Intervention Description
Investigational silicone hydrogel contact lenses
Intervention Type
Device
Intervention Name(s)
Comfilcon A contact lenses
Other Intervention Name(s)
CooperVision® BIOFINITY®, Biofinity
Intervention Description
Commercially available silicone hydrogel contact lenses
Intervention Type
Device
Intervention Name(s)
CLEAR CARE
Other Intervention Name(s)
CLEAR CARE® Cleaning & Disinfecting Solution
Intervention Description
Hydrogen peroxide-based system for cleaning and disinfecting silicone hydrogel contact lenses
Primary Outcome Measure Information:
Title
Distance VA (logMAR) With Study Lenses - Completed Eyes
Description
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.
Time Frame
Dispense, Week 1 follow-up, Week 2 follow-up, Month 1 follow-up, Month 2 follow-up, Month 3 follow-up (at least 4 hours after lens insertion at each follow-up assessment visit)
Title
Distance VA (logMAR) With Study Lenses - Discontinued Eyes
Description
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.
Time Frame
Dispense, Week 1 follow-up, Week 2 follow-up, Month 1 follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Successful wear of spherical daily wear frequent replacement soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day. Manifest cylinder equal to or less than 0.75 diopter (D) in each eye. Other protocol-specified inclusion criteria may apply. Key Exclusion Criteria: Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment. Habitually wearing Biofinity contact lenses. Monovision contact lens wearers. Other protocol-specified exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CDMA Project Lead, Vision Care
Organizational Affiliation
Alcon Research, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Alcon Investigative Site
City
Longwood
State/Province
Florida
ZIP/Postal Code
32779
Country
United States
Facility Name
Alcon Investigative Site
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Alcon Investigative Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Alcon Investigative Site
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61704
Country
United States
Facility Name
Alcon Investigative Site
City
Medina
State/Province
Minnesota
ZIP/Postal Code
55340
Country
United States
Facility Name
Alcon Investigative Site
City
Granville
State/Province
Ohio
ZIP/Postal Code
43023
Country
United States
Facility Name
Alcon Investigative Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38111
Country
United States
Facility Name
Alcon Investigative Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Evaluation of a Daily Wear Monthly Replacement Silicone Hydrogel Lens

We'll reach out to this number within 24 hrs