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Clinical Comparison of Two Daily Disposable Toric Soft Contact Lenses

Primary Purpose

Astigmatism, Ametropia, Myopia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Verofilcon A toric soft contact lenses
Stenfilcon A toric soft contact lenses
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Astigmatism focused on measuring Contact lenses, Vision, Eye sight

Eligibility Criteria

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

Key Inclusion Criteria:

  • Successful wearers of toric soft contact lenses in both eyes with at least 3 months wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day.
  • Able to wear contact lenses within a range of sphere & cylinder power and axes.
  • Willing to NOT use rewetting/lubricating drops at any time during the study.
  • Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

  • Current or previous P1fA and MDT habitual lens wearers.
  • Monovision and multifocal lens wearers.
  • Participation of the subject in a clinical trial within the previous 30 days or currently enrolled in any clinical trial.
  • Other protocol-defined exclusion criteria may apply.

Sites / Locations

  • Alcon Investigator 8135
  • Alcon Investigator 6356
  • Alcon Investigator 6565
  • Alcon Investigator 6355
  • Alcon Investigator 6614
  • Alcon Investigator 6567
  • Alcon Investigator 6645
  • Alcon Investigator 6402
  • Alcon Investigator 8046
  • Alcon Investigator 6401
  • Alcon Investigator 6353

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

P1fA, then MDT

MDT, then P1fA

Arm Description

Verofilcon A toric soft contact lenses worn first, followed by stenfilcon A toric soft contact lenses. Each study lens type will be worn for 8 (-0/+3) days for at least 10 hours per day. The lenses will be removed nightly and disposed of after a single use.

Stenfilcon A toric soft contact lenses worn first, followed by verofilcon A toric soft contact lenses. Each study lens type will be worn for 8 (-0/+3) days for at least 10 hours per day. The lenses will be removed nightly and disposed of after a single use.

Outcomes

Primary Outcome Measures

Distance Visual Acuity (VA) with study lenses at Week 1, collected for each eye in logMAR
Distance VA will be assessed with study lenses in place. VA will be 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 29, 2022
Last Updated
November 1, 2022
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT05483127
Brief Title
Clinical Comparison of Two Daily Disposable Toric Soft Contact Lenses
Official Title
Clinical Comparison of Two Daily Disposable Toric Soft Contact Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
September 13, 2022 (Actual)
Primary Completion Date
October 31, 2022 (Actual)
Study Completion Date
October 31, 2022 (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 primary purpose of this study is to demonstrate noninferiority in the visual acuity at distance when wearing PRECISION1™ for Astigmatism (P1fA) soft contact lenses compared to another commercially available, soft toric contact lens, MyDay® toric (MDT).
Detailed Description
Study participants will wear each study lens type in 1 of 2 randomized, crossover sequences. Participants will be expected to attend 4 visits and wear study lenses for at least 10 hours per day. The total duration of an individual's participation in the study will be up to 28 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Astigmatism, Ametropia, Myopia
Keywords
Contact lenses, Vision, Eye sight

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
P1fA, then MDT
Arm Type
Other
Arm Description
Verofilcon A toric soft contact lenses worn first, followed by stenfilcon A toric soft contact lenses. Each study lens type will be worn for 8 (-0/+3) days for at least 10 hours per day. The lenses will be removed nightly and disposed of after a single use.
Arm Title
MDT, then P1fA
Arm Type
Other
Arm Description
Stenfilcon A toric soft contact lenses worn first, followed by verofilcon A toric soft contact lenses. Each study lens type will be worn for 8 (-0/+3) days for at least 10 hours per day. The lenses will be removed nightly and disposed of after a single use.
Intervention Type
Device
Intervention Name(s)
Verofilcon A toric soft contact lenses
Other Intervention Name(s)
PRECISION1™ for Astigmatism, P1fA
Intervention Description
Soft contact lenses for optical correction of ametropia and astigmatism
Intervention Type
Device
Intervention Name(s)
Stenfilcon A toric soft contact lenses
Other Intervention Name(s)
MyDay® toric soft contact lenses, MDT
Intervention Description
Soft contact lenses for optical correction of ametropia and astigmatism
Primary Outcome Measure Information:
Title
Distance Visual Acuity (VA) with study lenses at Week 1, collected for each eye in logMAR
Description
Distance VA will be assessed with study lenses in place. VA will be 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
Approximately 1 week, 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 wearers of toric soft contact lenses in both eyes with at least 3 months wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day. Able to wear contact lenses within a range of sphere & cylinder power and axes. Willing to NOT use rewetting/lubricating drops at any time during the study. Other protocol-defined inclusion criteria may apply. Key Exclusion Criteria: Current or previous P1fA and MDT habitual lens wearers. Monovision and multifocal lens wearers. Participation of the subject in a clinical trial within the previous 30 days or currently enrolled in any clinical trial. Other protocol-defined exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sr. 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 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 6355
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
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 6567
City
Pittsburg
State/Province
Kansas
ZIP/Postal Code
66762
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 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

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Comparison of Two Daily Disposable Toric Soft Contact Lenses

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