Back to resultsEvaluation of Wear Experience With Daily Disposable and Monthly Replacement Toric Contact Lenses
Primary Purpose
Astigmatism Bilateral
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Daily disposable toric soft contact lens
Monthly replacement toric daily wear soft contact lens
Sponsored by
About this trial
This is an interventional treatment trial for Astigmatism Bilateral focused on measuring contact lenses, astigmatism
Eligibility Criteria
Inclusion Criteria:
- Subjects must be current soft lens wearers in both eyes.
- Subjects must have 20/25 or better distance visual acuity with current lenses (entering acuity).
- 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
- Willing to spend time for the study. Subjects will be required to attend two study visits and wear contact lenses on days between study visits.
- Either gender
- Any racial or ethnic origin
Exclusion Criteria:
- Participants cannot be pregnant or lactating.
- Participants cannot be current wearers of the study lenses
- No current ocular inflammation or infection as assessed by the study investigator
Sites / Locations
- Complete Eye Care of Medina
- The Ohio State University College of Optometry
- ProCare Vision Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
First lens wear experience
Second lens wear experience
Arm Description
Subject will wear contact lenses for 30 days during the day only.
Subject will wear contact lenses for 30 days during the day only.
Outcomes
Primary Outcome Measures
Visual analog scale survey of overall comfort
Visual analog scale survey of comfort from 0 to 100, with 0 anchored as "poor" and 100 as "excellent"
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05580575
Brief Title
Evaluation of Wear Experience With Daily Disposable and Monthly Replacement Toric Contact Lenses
Official Title
Evaluation of Wear Experience With Daily Disposable and Monthly Replacement Toric
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
March 9, 2023 (Actual)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
Comparison of wear experience with daily disposable and monthly replacement soft contact lenses in contact lens wearers who have astigmatism.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Astigmatism Bilateral
Keywords
contact lenses, astigmatism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
First lens wear experience
Arm Type
Experimental
Arm Description
Subject will wear contact lenses for 30 days during the day only.
Arm Title
Second lens wear experience
Arm Type
Experimental
Arm Description
Subject will wear contact lenses for 30 days during the day only.
Intervention Type
Device
Intervention Name(s)
Daily disposable toric soft contact lens
Intervention Description
Daily disposable toric soft contact lens
Intervention Type
Device
Intervention Name(s)
Monthly replacement toric daily wear soft contact lens
Intervention Description
Monthly replacement toric daily wear soft contact lens
Primary Outcome Measure Information:
Title
Visual analog scale survey of overall comfort
Description
Visual analog scale survey of comfort from 0 to 100, with 0 anchored as "poor" and 100 as "excellent"
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects must be current soft lens wearers in both eyes.
Subjects must have 20/25 or better distance visual acuity with current lenses (entering acuity).
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
Willing to spend time for the study. Subjects will be required to attend two study visits and wear contact lenses on days between study visits.
Either gender
Any racial or ethnic origin
Exclusion Criteria:
Participants cannot be pregnant or lactating.
Participants cannot be current wearers of the study lenses
No current ocular inflammation or infection as assessed by the study investigator
Facility Information:
Facility Name
Complete Eye Care of Medina
City
Medina
State/Province
Minnesota
ZIP/Postal Code
55340
Country
United States
Facility Name
The Ohio State University College of Optometry
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
ProCare Vision Center
City
Granville
State/Province
Ohio
ZIP/Postal Code
43023
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Wear Experience With Daily Disposable and Monthly Replacement Toric Contact Lenses
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