Clinical Comparison of 2 Daily Disposable Toric Soft Contact Lenses
December 6, 2021 updated by: Alcon Research
The purpose of this study to evaluate the overall performance of PRECISION1™ for Astigmatism contact lenses with MyDay® Toric contact lenses.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Subjects will be expected to attend 4 visits and wear study lenses daily for approximately 10 hours per day.
On the day prior to the Week 1 Follow-up visit of each crossover period, subjects will be asked to wear the respective study lens for at least 16 hours.
The expected duration of subject participation in the study is approximately 3 weeks.
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Maitland, Florida, United States, 32751
- Alcon Investigator 6565
-
-
Kansas
-
Pittsburg, Kansas, United States, 66762
- Alcon Investigator 6567
-
-
Michigan
-
Sterling Heights, Michigan, United States, 48312
- Alcon Investigator 8097
-
-
Ohio
-
Powell, Ohio, United States, 43065
- Alcon Investigator 6313
-
-
Rhode Island
-
Warwick, Rhode Island, United States, 02888
- Alcon Investigator 6401
-
-
Tennessee
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Memphis, Tennessee, United States, 38111
- Alcon Investigator 6353
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
- Willing to wear study contact lenses for at least 16 hours on the day prior to the Week 1 Follow up visit of each lens type.
- Other protocol-defined inclusion criteria may apply.
Key Exclusion Criteria:
- Current/previous wear of PRECISION1 for Astigmatism or MyDay Toric contact lenses.
- Current wear of spherical contact lenses.
- Wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week).
- Other protocol-defined exclusion criteria may apply.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
OTHER: P1fA, then MyDay Toric
Verofilcon A toric contact lenses worn first, with stenfilcon A toric contact lenses worn second, as randomized.
Each product will be worn bilaterally (in both eyes) for 8 (-0/+3) days in a daily disposable modality.
|
Soft contact lenses for optical correction of astigmatism, used as indicated
Other Names:
Soft contact lenses for optical correction of astigmatism, used as indicated
Other Names:
|
|
OTHER: MyDay Toric, then P1fA
Stenfilcon A toric contact lenses worn first, with verofilcon A toric contact lenses worn second, as randomized.
Each product will be worn bilaterally (in both eyes) for 8 (-0/+3) days in a daily disposable modality.
|
Soft contact lenses for optical correction of astigmatism, used as indicated
Other Names:
Soft contact lenses for optical correction of astigmatism, used as indicated
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percent of lenses with axis orientation within ±30 degrees inclusive from the intended axis, 10 minutes after lens insertion
Time Frame: Day 1, 10 minutes after lens insertion, each product
|
Axis orientation (orientation of the scribe mark) will be assessed by slit lamp examination and recorded as deviations from intended axis.
|
Day 1, 10 minutes after lens insertion, each product
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 28, 2021
Primary Completion (ACTUAL)
November 29, 2021
Study Completion (ACTUAL)
November 29, 2021
Study Registration Dates
First Submitted
August 31, 2021
First Submitted That Met QC Criteria
September 1, 2021
First Posted (ACTUAL)
September 9, 2021
Study Record Updates
Last Update Posted (ACTUAL)
December 7, 2021
Last Update Submitted That Met QC Criteria
December 6, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLA306-E001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.