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Clinical Evaluation of a Daily Wear Silicone Hydrogel Lens

Primary Purpose

Refractive Errors, Myopia, Hyperopia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LID015385 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 Lenses

Eligibility Criteria

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

Key Inclusion Criteria:

  • Understand and sign an IRB/IEC approved Informed Consent form.
  • Willing and able to attend all scheduled study visits and wear the assigned study lenses as required per protocol.
  • Successful wear of frequent replacement, spherical, daily wear 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 ≤ 0.75 diopter (D) in each eye.
  • Best spectacle corrected visual acuity 20/20 or better in each eye.
  • Other protocol-defined 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.
  • Monovision contact lens wear.
  • Any habitual wear of Biofinity lenses.
  • Other protocol-defined exclusion criteria may apply.

Sites / Locations

  • Alcon Investigator 8103
  • Alcon Investigator 8101
  • Alcon Investigator 8102
  • Alcon Investigator 8135
  • Alcon Investigator 8108
  • Alcon Investigator 8062
  • Alcon Investigator 8109
  • Alcon Investigator 6565
  • Alcon Investigator 6355
  • Alcon Investigator 8115
  • Alcon Investigator 6567
  • Alcon Investigator 8063
  • Alcon Investigator 8100
  • Alcon Investigator 4817
  • Alcon Investigator 6313
  • Alcon Investigator 6401
  • Alcon Investigator 6353
  • Alcon Investigator 8114

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LID015385

Biofinity

Arm Description

LID015385 contact lenses worn at least 5 days per week and 8 hours per day in a daily wear modality (that is, not worn while sleeping) for approximately 3 months. CLEAR CARE will be used for nightly cleaning and disinfection.

Comfilcon A contact lenses worn at least 5 days per week and 8 hours per day in a daily wear modality (that is, not worn while sleeping) for approximately 3 months. CLEAR CARE will be used for nightly cleaning and disinfection.

Outcomes

Primary Outcome Measures

Least Squares Mean Contact Lens Corrected Distance Visual Acuity (CLCDVA) in Each Eye (CLL949-C018 + CLL949-C009)
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 lower logMAR values indicating better visual acuity.

Secondary Outcome Measures

Percentage of Subjects Achieving CLCDVA 20/20 or Better in Each Eye (CLL949-C018 + CLL949-C009)
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, with 20/20 Snellen visual acuity considered normal distance eyesight.

Full Information

First Posted
December 19, 2019
Last Updated
February 1, 2022
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT04207749
Brief Title
Clinical Evaluation of a Daily Wear Silicone Hydrogel Lens
Official Title
Clinical Evaluation of a Daily Wear Silicone Hydrogel Lens
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
January 22, 2020 (Actual)
Primary Completion Date
December 17, 2020 (Actual)
Study Completion Date
December 17, 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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this clinical study is to assess the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in a daily wear modality with frequent replacement.
Detailed Description
Subjects will attend 4 office visits: Screening/Baseline/Dispense; Week 1 Follow-up; Month 1 Follow-up; and Month 3 Follow-up/Exit. The total expected duration of participation for each subject 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, Myopia, Hyperopia
Keywords
Contact Lenses

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
LID015385
Arm Type
Experimental
Arm Description
LID015385 contact lenses worn at least 5 days per week and 8 hours per day in a daily wear modality (that is, not worn while sleeping) for approximately 3 months. CLEAR CARE will be used for nightly cleaning and disinfection.
Arm Title
Biofinity
Arm Type
Active Comparator
Arm Description
Comfilcon A contact lenses worn at least 5 days per week and 8 hours per day in a daily wear modality (that is, not worn while sleeping) for approximately 3 months. CLEAR CARE will be used for nightly cleaning and disinfection.
Intervention Type
Device
Intervention Name(s)
LID015385 contact lenses
Intervention Description
Investigational soft contact lenses
Intervention Type
Device
Intervention Name(s)
Comfilcon A contact lenses
Other Intervention Name(s)
BIOFINITY®
Intervention Description
Commercially available soft contact lenses
Intervention Type
Device
Intervention Name(s)
CLEAR CARE
Intervention Description
Hydrogen peroxide-based cleaning and disinfecting solution
Primary Outcome Measure Information:
Title
Least Squares Mean Contact Lens Corrected Distance Visual Acuity (CLCDVA) in Each Eye (CLL949-C018 + CLL949-C009)
Description
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 lower logMAR values indicating better visual acuity.
Time Frame
Week 1 Follow-Up
Secondary Outcome Measure Information:
Title
Percentage of Subjects Achieving CLCDVA 20/20 or Better in Each Eye (CLL949-C018 + CLL949-C009)
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, with 20/20 Snellen visual acuity considered normal distance eyesight.
Time Frame
Week 1 Follow-Up, at least 4 hours after lens insertion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Understand and sign an IRB/IEC approved Informed Consent form. Willing and able to attend all scheduled study visits and wear the assigned study lenses as required per protocol. Successful wear of frequent replacement, spherical, daily wear 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 ≤ 0.75 diopter (D) in each eye. Best spectacle corrected visual acuity 20/20 or better in each eye. Other protocol-defined 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. Monovision contact lens wear. Any habitual wear of Biofinity lenses. Other protocol-defined exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sr. Clinical Trial Lead, CDMA Vision Care
Organizational Affiliation
Alcon Research, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Alcon Investigator 8103
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85308
Country
United States
Facility Name
Alcon Investigator 8101
City
Brentwood
State/Province
California
ZIP/Postal Code
94513
Country
United States
Facility Name
Alcon Investigator 8102
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Facility Name
Alcon Investigator 8135
City
Los Angeles
State/Province
California
ZIP/Postal Code
90012
Country
United States
Facility Name
Alcon Investigator 8108
City
Novato
State/Province
California
ZIP/Postal Code
94945
Country
United States
Facility Name
Alcon Investigator 8062
City
Oakland
State/Province
California
ZIP/Postal Code
94607
Country
United States
Facility Name
Alcon Investigator 8109
City
San Francisco
State/Province
California
ZIP/Postal Code
94127
Country
United States
Facility Name
Alcon Investigator 6565
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Alcon Investigator 6355
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Alcon Investigator 8115
City
Norcross
State/Province
Georgia
ZIP/Postal Code
30071
Country
United States
Facility Name
Alcon Investigator 6567
City
Pittsburg
State/Province
Kansas
ZIP/Postal Code
66762
Country
United States
Facility Name
Alcon Investigator 8063
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Alcon Investigator 8100
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Facility Name
Alcon Investigator 4817
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Alcon Investigator 6313
City
Powell
State/Province
Ohio
ZIP/Postal Code
43065
Country
United States
Facility Name
Alcon Investigator 6401
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02888
Country
United States
Facility Name
Alcon Investigator 6353
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38111
Country
United States
Facility Name
Alcon Investigator 8114
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Clinical Evaluation of a Daily Wear Silicone Hydrogel Lens

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