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Clinical Comparison of Two Daily Disposable Contact Lenses - Pilot Study 3

Primary Purpose

Myopia, Ametropia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Verofilcon A contact lenses
Kalifilcon A contact lenses
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

Key Inclusion Criteria:

  • Able to understand and sign an Informed Consent Form that been approved by an Institutional Review Board.
  • Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
  • Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

  • Current/previous PRECISION1 or INFUSE contact lens wearer.
  • Any eye condition or use of medication that contraindicates contact lens wear, as determined by the investigator.
  • Routinely sleeps in contact lenses.
  • Other protocol-defined exclusion criteria may apply.

Sites / Locations

  • Alcon Investigator 6565
  • Alcon Investigator 6355
  • Alcon Investigator 6583
  • Alcon Investigator 6313

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Precision1, then Infuse

Infuse, then Precision1

Arm Description

Verofilcon A contact lenses worn first, with kalifilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.

Kalifilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.

Outcomes

Primary Outcome Measures

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. No inferential testing was pre-specified for this endpoint.

Secondary Outcome Measures

Full Information

First Posted
June 21, 2021
Last Updated
August 16, 2022
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT04942925
Brief Title
Clinical Comparison of Two Daily Disposable Contact Lenses - Pilot Study 3
Official Title
Clinical Comparison of Two Daily Disposable Contact Lenses - Pilot Study 3
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
July 20, 2021 (Actual)
Primary Completion Date
September 9, 2021 (Actual)
Study Completion Date
September 9, 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 evaluate the overall performance of PRECISION1™ contact lenses when compared to INFUSE™ contact lenses.
Detailed Description
The expected duration of subject participation in the study is up to 24 days with 3 scheduled visits.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Subjects will receive treatment based upon the randomized treatment sequence assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Precision1, then Infuse
Arm Type
Other
Arm Description
Verofilcon A contact lenses worn first, with kalifilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.
Arm Title
Infuse, then Precision1
Arm Type
Other
Arm Description
Kalifilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.
Intervention Type
Device
Intervention Name(s)
Verofilcon A contact lenses
Other Intervention Name(s)
PRECISION1™
Intervention Description
Commercially available silicone hydrogel contact lenses for daily disposable wear
Intervention Type
Device
Intervention Name(s)
Kalifilcon A contact lenses
Other Intervention Name(s)
Bausch + Lomb INFUSE™
Intervention Description
Commercially available silicone hydrogel contact lenses for daily disposable wear
Primary Outcome Measure Information:
Title
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. No inferential testing was pre-specified for this endpoint.
Time Frame
Day 8 (-0/+3 days), each study lens type

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Able to understand and sign an Informed Consent Form that been approved by an Institutional Review Board. Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months. Other protocol-defined inclusion criteria may apply. Key Exclusion Criteria: Current/previous PRECISION1 or INFUSE contact lens wearer. Any eye condition or use of medication that contraindicates contact lens wear, as determined by the investigator. Routinely sleeps in contact lenses. 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 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 6583
City
Eden Prairie
State/Province
Minnesota
ZIP/Postal Code
55344
Country
United States
Facility Name
Alcon Investigator 6313
City
Powell
State/Province
Ohio
ZIP/Postal Code
43065
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Comparison of Two Daily Disposable Contact Lenses - Pilot Study 3

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