Back to resultsClinical Performance of a Daily Disposable Toric Silicone Hydrogel Contact Lens
Primary Purpose
Astigmatism
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
verofilcon A toric contact lenses
Sponsored by
About this trial
This is an interventional device feasibility trial for Astigmatism focused on measuring Toric contact lens, Daily disposable, Silicone hydrogel contact lens, Axis orientation, Astigmatism
Eligibility Criteria
Inclusion Criteria:
- Able to understand and sign an informed consent form;
- Successful wear of spherical or toric soft contact lenses in both eyes, as specified in the protocol;
- Willing to NOT use rewetting/lubricating drops at any time during the study;
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
- Any eye condition that would contraindicate contact lens wear, as determined by the Investigator;
- History of eye surgery within the previous 12 months, as specified in the protocol;
- Current or history of dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear;
- Other protocol-specified exclusion criteria may apply.
Sites / Locations
- Contact Alcon Call Center for Trial Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DDT2 Toric
Arm Description
Verofilcon A toric contact lenses worn in both eyes
Outcomes
Primary Outcome Measures
Percent of lenses with axis orientation within ±30° from the intended axis, 10 minutes after lens insertion
Axis orientation (orientation of the scribe mark) will be assessed by slit lamp examination and recorded as deviations from intended axis.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04464044
Brief Title
Clinical Performance of a Daily Disposable Toric Silicone Hydrogel Contact Lens
Official Title
Clinical Performance of a Daily Disposable Toric Silicone Hydrogel Contact Lens
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
July 20, 2020 (Actual)
Primary Completion Date
August 6, 2020 (Actual)
Study Completion Date
August 6, 2020 (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 obtain on-eye clinical performance data to evaluate the stability of axis orientation of DDT2 toric contact lenses in the intended population.
Detailed Description
This is a single-visit, non-dispense study where subjects will be exposed to the test lenses for approximately 1 hour.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Astigmatism
Keywords
Toric contact lens, Daily disposable, Silicone hydrogel contact lens, Axis orientation, Astigmatism
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DDT2 Toric
Arm Type
Experimental
Arm Description
Verofilcon A toric contact lenses worn in both eyes
Intervention Type
Device
Intervention Name(s)
verofilcon A toric contact lenses
Other Intervention Name(s)
DDT2 Toric
Intervention Description
Daily disposable toric soft contact lenses
Primary Outcome Measure Information:
Title
Percent of lenses with axis orientation within ±30° from the intended axis, 10 minutes after lens insertion
Description
Axis orientation (orientation of the scribe mark) will be assessed by slit lamp examination and recorded as deviations from intended axis.
Time Frame
Day 1, 10 minutes after lens insertion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Able to understand and sign an informed consent form;
Successful wear of spherical or toric soft contact lenses in both eyes, as specified in the protocol;
Willing to NOT use rewetting/lubricating drops at any time during the study;
Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
Any eye condition that would contraindicate contact lens wear, as determined by the Investigator;
History of eye surgery within the previous 12 months, as specified in the protocol;
Current or history of dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear;
Other protocol-specified 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 Director
Facility Information:
Facility Name
Contact Alcon Call Center for Trial Locations
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Performance of a Daily Disposable Toric Silicone Hydrogel Contact Lens
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