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Clinical Comparison of Two Daily Disposable Contact Lenses

Primary Purpose

Refractive Errors

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

Eligibility Criteria

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

Key Inclusion Criteria

  • Successful wearer of spherical soft contact lenses with at least 3 months wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day.
  • Possess spectacles and willing to wear habitual spectacles for vision correction when study lenses are not worn, as needed.
  • Willing to wear contact lenses for at least 16 hours on one of the days (day prior to each week 1 visit).
  • Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

  • Habitual PRECISION1, Clariti 1-Day, and DAILIES TOTAL1 contact lens wearers.
  • Any monovision and multifocal lens wearers.
  • Other protocol-specified exclusion criteria may apply.

Sites / Locations

  • Alcon Investigator 8106
  • Alcon Investigator 6565
  • Alcon Investigator 6418
  • Alcon Investigator 6614
  • Alcon Investigator 6645
  • Alcon Investigator 6402
  • Alcon Investigator 8046
  • Alcon Investigator 8028

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

PRECISION1, then Clariti 1-Day

Clariti 1-Day, then PRECISION1

Arm Description

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

Somofilcon 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 days in a daily disposable modality.

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
April 26, 2021
Last Updated
June 9, 2022
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT04865354
Brief Title
Clinical Comparison of Two Daily Disposable Contact Lenses
Official Title
Clinical Comparison of Two Daily Disposable Contact Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
May 17, 2021 (Actual)
Primary Completion Date
June 27, 2021 (Actual)
Study Completion Date
June 27, 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 PRECISION1™ contact lenses to Clariti® 1 day contact lenses.
Detailed Description
Subjects will be expected to attend 3 study visits and wear the study lenses daily for at least 10 hours per day. On the day prior to Visits 2 and 3, subjects will be expected to wear the study lenses for at least 16 hours. The total duration of subject participation will be up to 22 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Errors
Keywords
Contact Lenses, Disposable

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
PRECISION1, then Clariti 1-Day
Arm Type
Other
Arm Description
Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 days in a daily disposable modality.
Arm Title
Clariti 1-Day, then PRECISION1
Arm Type
Other
Arm Description
Somofilcon 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 days in a daily disposable modality.
Intervention Type
Device
Intervention Name(s)
Verofilcon A contact lenses
Other Intervention Name(s)
PRECISION1
Intervention Description
Spherical soft contact lenses for daily disposable wear
Intervention Type
Device
Intervention Name(s)
Somofilcon A contact lenses
Other Intervention Name(s)
Clariti 1-Day
Intervention Description
Spherical soft contact lenses for daily disposable wear
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 8, each study lens type

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria Successful wearer of spherical soft contact lenses with at least 3 months wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day. Possess spectacles and willing to wear habitual spectacles for vision correction when study lenses are not worn, as needed. Willing to wear contact lenses for at least 16 hours on one of the days (day prior to each week 1 visit). Other protocol-specified inclusion criteria may apply. Key Exclusion Criteria: Habitual PRECISION1, Clariti 1-Day, and DAILIES TOTAL1 contact lens wearers. Any monovision and multifocal lens wearers. Other protocol-specified exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CDMA Clinical Trial Lead, Vision Care
Organizational Affiliation
Alcon Research, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Alcon Investigator 8106
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 6418
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Alcon Investigator 6614
City
Franklin Park
State/Province
Illinois
ZIP/Postal Code
60131
Country
United States
Facility Name
Alcon Investigator 6645
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66204
Country
United States
Facility Name
Alcon Investigator 6402
City
Medina
State/Province
Minnesota
ZIP/Postal Code
55340
Country
United States
Facility Name
Alcon Investigator 8046
City
Granville
State/Province
Ohio
ZIP/Postal Code
43023
Country
United States
Facility Name
Alcon Investigator 8028
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76308
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

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