Back to resultsClinical Performance Evaluation of Two Daily Disposable Silicone Hydrogel Toric Contact Lenses
Primary Purpose
Refractive Errors
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DT1 Toric contact lenses
AO1DfA contact lenses
Sponsored by
About this trial
This is an interventional device feasibility trial for Refractive Errors focused on measuring toric contact lens, daily disposable, silicone hydrogel contact lens, axis orientation, astigmatism
Eligibility Criteria
Inclusion Criteria:
- Current wearer of any commercial soft daily wear contact lens with at least 3 months of wearing experience with a minimum wearing time of 5 days per week and 8 hours per day.
- Requiring contact lens (manifest refraction) of a cylindrical power of -0.75 to -2.50 diopter cylinder (DC).
- Best corrected distance visual acuity 20/25 or better Snellen in each eye (as determined by manifest refraction at screening).
- Willing to NOT use rewetting/lubricating drops at any time during the study. Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Any anterior segment infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator.
- Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator.
- History of refractive surgery or plan to have refractive surgery during the study or irregular cornea in either eye.
- Eye injury in either eye within 12 weeks immediately prior to enrollment for this trial.
Other protocol-defined exclusion criteria may apply.
Sites / Locations
- Alcon Investigative Site CT-11
- Alcon Investigative Site CT-27
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Test, then Control
Control, then Test
Arm Description
DT1 Toric contact lenses worn first, followed by AO1DfA contact lenses, as randomized. Each product will be worn in both eyes for approximately 1 hour.
AO1DfA contact lenses worn first, followed by DT1 Toric contact lenses, as randomized. Each product will be worn in both eyes for approximately 1 hour.
Outcomes
Primary Outcome Measures
Percent of DT1 toric lenses with axis orientation within ±30° from the intended axis, 10 min after lens insertion
A slit lamp will be used to observe axis orientation.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04254003
Brief Title
Clinical Performance Evaluation of Two Daily Disposable Silicone Hydrogel Toric Contact Lenses
Official Title
Clinical Performance Evaluation of Two Daily Disposable Silicone Hydrogel Toric Contact Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
February 5, 2020 (Actual)
Primary Completion Date
March 2, 2020 (Actual)
Study Completion Date
March 2, 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 evaluate the rotational behavior of DT1 Toric contact lenses.
Detailed Description
This is a single visit, non-dispense study where subjects will be exposed to the test and control lenses for approximately 1 hour each.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Errors
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
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test, then Control
Arm Type
Other
Arm Description
DT1 Toric contact lenses worn first, followed by AO1DfA contact lenses, as randomized. Each product will be worn in both eyes for approximately 1 hour.
Arm Title
Control, then Test
Arm Type
Other
Arm Description
AO1DfA contact lenses worn first, followed by DT1 Toric contact lenses, as randomized. Each product will be worn in both eyes for approximately 1 hour.
Intervention Type
Device
Intervention Name(s)
DT1 Toric contact lenses
Other Intervention Name(s)
Test, DAILIES TOTAL1 for Astigmatism (DT1 Toric)
Intervention Description
Delefilcon A contact lenses for the optical correction of astigmatism in people with healthy eyes with or without refractive ametropia (myopia or hyperopia)
Intervention Type
Device
Intervention Name(s)
AO1DfA contact lenses
Other Intervention Name(s)
Control, Acuvue Oasys 1-Day for Astigmatism (AO1DfA)
Intervention Description
Senofilcon A contact lenses for the optical correction of astigmatism in people with healthy eyes with or without refractive ametropia (myopia or hyperopia)
Primary Outcome Measure Information:
Title
Percent of DT1 toric lenses with axis orientation within ±30° from the intended axis, 10 min after lens insertion
Description
A slit lamp will be used to observe axis orientation.
Time Frame
Day 1, 10 minutes after lens insertion, each product
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Current wearer of any commercial soft daily wear contact lens with at least 3 months of wearing experience with a minimum wearing time of 5 days per week and 8 hours per day.
Requiring contact lens (manifest refraction) of a cylindrical power of -0.75 to -2.50 diopter cylinder (DC).
Best corrected distance visual acuity 20/25 or better Snellen in each eye (as determined by manifest refraction at screening).
Willing to NOT use rewetting/lubricating drops at any time during the study. Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Any anterior segment infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator.
Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator.
History of refractive surgery or plan to have refractive surgery during the study or irregular cornea in either eye.
Eye injury in either eye within 12 weeks immediately prior to enrollment for this 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 Director
Facility Information:
Facility Name
Alcon Investigative Site CT-11
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Alcon Investigative Site CT-27
City
Eden Prairie
State/Province
Minnesota
ZIP/Postal Code
55344
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Performance Evaluation of Two Daily Disposable Silicone Hydrogel Toric Contact Lenses
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