Back to resultsWear Experience With Daily Toric Contact Lenses Over a Long Day
Primary Purpose
Contact Lens, Astigmatism of Both Eyes
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Precision1® Daily Disposable Toric Contact Lens
Sponsored by
About this trial
This is an interventional treatment trial for Contact Lens focused on measuring Toric Contact Lens, Daily Contact Lens
Eligibility Criteria
Inclusion Criteria:
- Must be current soft toric contact lens wearers with longs days of lens wear within the parameters of Precision1® lenses available.
- Distance visual acuity of 20/25 or better with current lenses.
- Recent eye exam in the last year.
- Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the PI).
- Ability to give informed consent.
- Must have a working smart phone or device and be willing to receive and respond to texts and/or emails.
- Willing to spend time for the study, which includes three in-person study visits (with a possible fourth visit if needed), wearing contact lenses on days between study visits, and responding to communications on a smart phone or other electronic device on five weekdays between Visits 2 and 3.
Exclusion Criteria:
- Current ocular inflammation or infection as assessed by the study investigator.
- Currently pregnant, lactating, or planning to become pregnant during the course of the study.
Sites / Locations
- The Ohio State University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Daily Disposable Toric Contact Lens
Arm Description
All subjects are fit into Precision1® toric contact lenses. Subjects are requested to wear the lenses for a total of two weeks.
Outcomes
Primary Outcome Measures
Comfort and vision in contact lenses assessed using a 1 to 10 scale.
1 describes poor experience, and 10 describes excellent experience.
Secondary Outcome Measures
Full Information
NCT ID
NCT04844281
First Posted
April 9, 2021
Last Updated
February 3, 2023
Sponsor
Ohio State University
Collaborators
Alcon Research
1. Study Identification
Unique Protocol Identification Number
NCT04844281
Brief Title
Wear Experience With Daily Toric Contact Lenses Over a Long Day
Official Title
Evaluation of Wear Experience With PRECISION1® Toric Contact Lenses on Long Lens Wear Days
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 11, 2021 (Actual)
Primary Completion Date
August 24, 2021 (Actual)
Study Completion Date
March 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
Collaborators
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.
Yes
5. Study Description
Brief Summary
This study is evaluating the wear experience of a daily toric contact lens after 10, 12, 14, and 16 hours of lens wear.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contact Lens, Astigmatism of Both Eyes
Keywords
Toric Contact Lens, Daily Contact Lens
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Daily Disposable Toric Contact Lens
Arm Type
Experimental
Arm Description
All subjects are fit into Precision1® toric contact lenses. Subjects are requested to wear the lenses for a total of two weeks.
Intervention Type
Device
Intervention Name(s)
Precision1® Daily Disposable Toric Contact Lens
Intervention Description
Soft, toric contact lens used to correct distance vision and astigmatism.
Primary Outcome Measure Information:
Title
Comfort and vision in contact lenses assessed using a 1 to 10 scale.
Description
1 describes poor experience, and 10 describes excellent experience.
Time Frame
Up to 14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Must be current soft toric contact lens wearers with longs days of lens wear within the parameters of Precision1® lenses available.
Distance visual acuity of 20/25 or better with current lenses.
Recent eye exam in the last year.
Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the PI).
Ability to give informed consent.
Must have a working smart phone or device and be willing to receive and respond to texts and/or emails.
Willing to spend time for the study, which includes three in-person study visits (with a possible fourth visit if needed), wearing contact lenses on days between study visits, and responding to communications on a smart phone or other electronic device on five weekdays between Visits 2 and 3.
Exclusion Criteria:
Current ocular inflammation or infection as assessed by the study investigator.
Currently pregnant, lactating, or planning to become pregnant during the course of the study.
Facility Information:
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Wear Experience With Daily Toric Contact Lenses Over a Long Day
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