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Clinical Assessment of Two Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lenses

Primary Purpose

Myopia

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 Myopia focused on measuring Contact lenses

Eligibility Criteria

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

Inclusion Criteria:

  • Able to understand and sign an approved Informed Consent form;
  • Willing and able to attend all scheduled study visits as required by the protocol;
  • Currently wearing any commercial spherical weekly/monthly soft contact lenses in both eyes for at least 3 months, minimum 5 days per week, 10 hours per day;
  • Manifest cylinder less than or equal to 0.75 diopter (D) in each eye;
  • Willing to stop wearing habitual contact lenses for the duration of study participation.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Any eye condition that contraindicates contact lens wear, as determined by the Investigator;
  • Any use of systemic or ocular medicine that contraindicates contact lens wear, as determined by the Investigator;
  • Ocular or intraocular surgery (excluding placement of punctal plugs) within the previous 12 months or planned during the study;
  • Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear;
  • Current or prior Biofinity contact lens wear in the past 3 months prior to consent.
  • Other protocol-defined exclusion criteria may apply.

Sites / Locations

  • Alcon Investigator 8135
  • Alcon Investigator 8062
  • Alcon Investigator 8106
  • Alcon Investigator 6356
  • Alcon Investigator 6565
  • Alcon Investigator 6654
  • Alcon Investigator 6567
  • Alcon Investigator 5582
  • Alcon Investigator 8097
  • Alcon Investigator 7980
  • Alcon Investigator 8130
  • Alcon Investigator 6401
  • Alcon Investigator 6353
  • Alcon Investigator 8175

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

TOTAL30, then Biofinity

Biofinity, then TOTAL30

Arm Description

Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses as randomized. Each study product will be worn bilaterally (in both eyes) for approximately 30 days for at least 10 hours per day during waking hours only. CLEAR CARE will be used for daily cleaning and disinfection.

Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each study product will be worn bilaterally (in both eyes) for at least 10 hours per day during waking hours only. CLEAR CARE will be used for daily cleaning and disinfection.

Outcomes

Primary Outcome Measures

Least Squares Mean Distance VA (logMAR) With Study Lenses
Distance visual acuity (VA) was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity.

Secondary Outcome Measures

Full Information

First Posted
July 19, 2021
Last Updated
December 13, 2022
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT04980456
Brief Title
Clinical Assessment of Two Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lenses
Official Title
Clinical Assessment of Two Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
August 5, 2021 (Actual)
Primary Completion Date
November 20, 2021 (Actual)
Study Completion Date
November 20, 2021 (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 study is to compare the clinical performance of TOTAL30 contact lenses with Biofinity contact lenses over 30 days of daily wear.
Detailed Description
Subjects will wear two products and be expected to attend 4 office visits. The individual duration of participation will be approximately 65 days, which includes approximately 30 days of exposure to the test product and approximately 30 days of exposure to the comparator product.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
Contact lenses

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
TOTAL30, then Biofinity
Arm Type
Other
Arm Description
Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses as randomized. Each study product will be worn bilaterally (in both eyes) for approximately 30 days for at least 10 hours per day during waking hours only. CLEAR CARE will be used for daily cleaning and disinfection.
Arm Title
Biofinity, then TOTAL30
Arm Type
Other
Arm Description
Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each study product will be worn bilaterally (in both eyes) for at least 10 hours per day during waking hours only. CLEAR CARE will be used for daily cleaning and disinfection.
Intervention Type
Device
Intervention Name(s)
Lehfilcon A contact lenses
Other Intervention Name(s)
TOTAL30
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
Intervention Description
Hydrogen peroxide-based cleaning and disinfecting solution
Primary Outcome Measure Information:
Title
Least Squares Mean Distance VA (logMAR) With Study Lenses
Description
Distance visual acuity (VA) was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity.
Time Frame
Day 30, each study product

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Able to understand and sign an approved Informed Consent form; Willing and able to attend all scheduled study visits as required by the protocol; Currently wearing any commercial spherical weekly/monthly soft contact lenses in both eyes for at least 3 months, minimum 5 days per week, 10 hours per day; Manifest cylinder less than or equal to 0.75 diopter (D) in each eye; Willing to stop wearing habitual contact lenses for the duration of study participation. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Any eye condition that contraindicates contact lens wear, as determined by the Investigator; Any use of systemic or ocular medicine that contraindicates contact lens wear, as determined by the Investigator; Ocular or intraocular surgery (excluding placement of punctal plugs) within the previous 12 months or planned during the study; Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear; Current or prior Biofinity contact lens wear in the past 3 months prior to consent. Other protocol-defined exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Lead, Vision Care
Organizational Affiliation
Alcon Research, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Alcon Investigator 8135
City
Los Angeles
State/Province
California
ZIP/Postal Code
90012
Country
United States
Facility Name
Alcon Investigator 8062
City
Oakland
State/Province
California
ZIP/Postal Code
94607
Country
United States
Facility Name
Alcon Investigator 8106
City
San Francisco
State/Province
California
ZIP/Postal Code
94127
Country
United States
Facility Name
Alcon Investigator 6356
City
Longwood
State/Province
Florida
ZIP/Postal Code
32779
Country
United States
Facility Name
Alcon Investigator 6565
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Alcon Investigator 6654
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33405
Country
United States
Facility Name
Alcon Investigator 6567
City
Pittsburg
State/Province
Kansas
ZIP/Postal Code
66762
Country
United States
Facility Name
Alcon Investigator 5582
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206
Country
United States
Facility Name
Alcon Investigator 8097
City
Sterling Heights
State/Province
Michigan
ZIP/Postal Code
48312
Country
United States
Facility Name
Alcon Investigator 7980
City
Willmar
State/Province
Minnesota
ZIP/Postal Code
56201
Country
United States
Facility Name
Alcon Investigator 8130
City
New York
State/Province
New York
ZIP/Postal Code
10036
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 8175
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Assessment of Two Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lenses

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