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Clinical Comparison of Toric Contact Lenses Fit Characteristics

Primary Purpose

Astigmatism, Refractive Errors

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Delefilcon A toric soft contact lens
Lehfilcon A toric soft contact lens
Lotrafilcon B toric soft contact lens
Verofilcon A toric soft contact lens
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

Eligibility Criteria

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

Key Inclusion Criteria: Successful wear of toric soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months. Able to be fit with contact lenses within the available range of sphere, cylinder power, and axes (based on lens availability). Best Corrected Visual Acuity (BCVA) better than or equal to 0.10 (logMAR) in each eye. Willing to stop wearing habitual contact lenses during in-office visits. Other protocol-defined inclusion criteria may apply. Key Exclusion Criteria: Current spherical, monovision or multifocal lens wearer. Protocol-specified biomicroscopy findings at screening. Current or history of herpetic keratitis in either eye. Participation 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

  • Kurata Eyecare Center
  • Omega Vision Center P.A.
  • Kindred Optics at Maitland Vision
  • Kannarr Eye Care LLC
  • ProCare Vision Centers, Inc.
  • Optometry Group, PLLC
  • Clarke EyeCare Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

DT1fA/T30fA/AOHGfA/P1fA

T30fA/AOHGfA/P1fA/DT1fA

AOHGfA/P1fA/DT1fA/T30fA

P1fA/DT1fA/T30fA/AOHGfA

Arm Description

DT1fA worn first, followed by T30fA, as randomized, during the first wear period, with AOHGfA worn first, followed by P1fA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days.

T30fA worn first, followed by AOHGfA, as randomized, during the first wear period, with P1fA worn first, followed by DT1fA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days.

AOHGfA worn first, followed by P1fA, as randomized, during the first wear period, with DT1fA worn first, followed by T30fA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days.

P1fA worn first, followed by DT1fA, as randomized, during the first wear period, with T30fA worn first, followed by AOHGfA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days.

Outcomes

Primary Outcome Measures

Distance VA with study lenses
Visual Acuity (VA) will be assessed using letter charts with study lenses in place and reported in logarithm minimum angle of resolution (logMAR). A logMAR value of 0.0 equates to 20/20 Snellen, which is considered normal distance eyesight. Eyes will be assessed individually.

Secondary Outcome Measures

Full Information

First Posted
March 23, 2023
Last Updated
May 18, 2023
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT05805345
Brief Title
Clinical Comparison of Toric Contact Lenses Fit Characteristics
Official Title
Clinical Comparison of Toric Contact Lenses Fit Characteristics
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Management Decision
Study Start Date
April 2023 (Anticipated)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

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 fit characteristics between four Alcon commercially available toric contact lenses.
Detailed Description
Subjects will be expected to attend 3 visits including the screening visit. The total duration of a subject's participation in the study will be approximately 19 days.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
DT1fA/T30fA/AOHGfA/P1fA
Arm Type
Other
Arm Description
DT1fA worn first, followed by T30fA, as randomized, during the first wear period, with AOHGfA worn first, followed by P1fA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days.
Arm Title
T30fA/AOHGfA/P1fA/DT1fA
Arm Type
Other
Arm Description
T30fA worn first, followed by AOHGfA, as randomized, during the first wear period, with P1fA worn first, followed by DT1fA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days.
Arm Title
AOHGfA/P1fA/DT1fA/T30fA
Arm Type
Other
Arm Description
AOHGfA worn first, followed by P1fA, as randomized, during the first wear period, with DT1fA worn first, followed by T30fA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days.
Arm Title
P1fA/DT1fA/T30fA/AOHGfA
Arm Type
Other
Arm Description
P1fA worn first, followed by DT1fA, as randomized, during the first wear period, with T30fA worn first, followed by AOHGfA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days.
Intervention Type
Device
Intervention Name(s)
Delefilcon A toric soft contact lens
Other Intervention Name(s)
DT1fA, DAILIES TOTAL1® for Astigmatism
Intervention Description
Commercially available silicone hydrogel contact lens
Intervention Type
Device
Intervention Name(s)
Lehfilcon A toric soft contact lens
Other Intervention Name(s)
T30fA, TOTAL30™ for Astigmatism
Intervention Description
Commercially available silicone hydrogel contact lens
Intervention Type
Device
Intervention Name(s)
Lotrafilcon B toric soft contact lens
Other Intervention Name(s)
AOHGfA, AIR OPTIX® plus HydraGlyde® for Astigmatism
Intervention Description
Commercially available silicone hydrogel contact lens
Intervention Type
Device
Intervention Name(s)
Verofilcon A toric soft contact lens
Other Intervention Name(s)
P1fA, PRECISION1® for Astigmatism
Intervention Description
Commercially available silicone hydrogel contact lens
Primary Outcome Measure Information:
Title
Distance VA with study lenses
Description
Visual Acuity (VA) will be assessed using letter charts with study lenses in place and reported in logarithm minimum angle of resolution (logMAR). A logMAR value of 0.0 equates to 20/20 Snellen, which is considered normal distance eyesight. Eyes will be assessed individually.
Time Frame
30 mins (± 15 mins), each product

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Successful wear of toric soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months. Able to be fit with contact lenses within the available range of sphere, cylinder power, and axes (based on lens availability). Best Corrected Visual Acuity (BCVA) better than or equal to 0.10 (logMAR) in each eye. Willing to stop wearing habitual contact lenses during in-office visits. Other protocol-defined inclusion criteria may apply. Key Exclusion Criteria: Current spherical, monovision or multifocal lens wearer. Protocol-specified biomicroscopy findings at screening. Current or history of herpetic keratitis in either eye. Participation 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
Clinical Trial Lead, Vision Care
Organizational Affiliation
Alcon Research, LLC
Official's Role
Study Chair
Facility Information:
Facility Name
Kurata Eyecare Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90013
Country
United States
Facility Name
Omega Vision Center P.A.
City
Longwood
State/Province
Florida
ZIP/Postal Code
32779
Country
United States
Facility Name
Kindred Optics at Maitland Vision
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Kannarr Eye Care LLC
City
Pittsburg
State/Province
Kansas
ZIP/Postal Code
66762
Country
United States
Facility Name
ProCare Vision Centers, Inc.
City
Granville
State/Province
Ohio
ZIP/Postal Code
43023
Country
United States
Facility Name
Optometry Group, PLLC
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38111
Country
United States
Facility Name
Clarke EyeCare Center
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 Toric Contact Lenses Fit Characteristics

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