- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04865354
Clinical Comparison of Two Daily Disposable Contact Lenses
June 9, 2022 updated by: Alcon Research
The purpose of this study is to compare the clinical performance of PRECISION1™ contact lenses to Clariti® 1 day contact lenses.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Subjects will be expected to attend 3 study visits and wear the study lenses daily for at least 10 hours per day.
On the day prior to Visits 2 and 3, subjects will be expected to wear the study lenses for at least 16 hours.
The total duration of subject participation will be up to 22 days.
Study Type
Interventional
Enrollment (Actual)
170
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
-
-
California
-
San Francisco, California, United States, 94127
- Alcon Investigator 8106
-
-
Florida
-
Maitland, Florida, United States, 32751
- Alcon Investigator 6565
-
Tallahassee, Florida, United States, 32308
- Alcon Investigator 6418
-
-
Illinois
-
Franklin Park, Illinois, United States, 60131
- Alcon Investigator 6614
-
-
Kansas
-
Shawnee Mission, Kansas, United States, 66204
- Alcon Investigator 6645
-
-
Minnesota
-
Medina, Minnesota, United States, 55340
- Alcon Investigator 6402
-
-
Ohio
-
Granville, Ohio, United States, 43023
- Alcon Investigator 8046
-
-
Texas
-
Wichita Falls, Texas, United States, 76308
- Alcon Investigator 8028
-
-
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 wearer of spherical soft contact lenses with at least 3 months wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day.
- Possess spectacles and willing to wear habitual spectacles for vision correction when study lenses are not worn, as needed.
- Willing to wear contact lenses for at least 16 hours on one of the days (day prior to each week 1 visit).
- Other protocol-specified inclusion criteria may apply.
Key Exclusion Criteria:
- Habitual PRECISION1, Clariti 1-Day, and DAILIES TOTAL1 contact lens wearers.
- Any monovision and multifocal lens wearers.
- Other protocol-specified 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: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: PRECISION1, then Clariti 1-Day
Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second, as randomized.
Each study lens type will be worn bilaterally (in both eyes) for 8 days in a daily disposable modality.
|
Spherical soft contact lenses for daily disposable wear
Other Names:
Spherical soft contact lenses for daily disposable wear
Other Names:
|
Other: Clariti 1-Day, then PRECISION1
Somofilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized.
Each study lens type will be worn bilaterally (in both eyes) for 8 days in a daily disposable modality.
|
Spherical soft contact lenses for daily disposable wear
Other Names:
Spherical soft contact lenses for daily disposable wear
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Least Squares Mean Distance VA (logMAR) With Study Lenses
Time Frame: Day 8, each study lens type
|
Distance visual acuity (VA) was assessed with study lenses in place.
VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts.
A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity.
|
Day 8, each study lens type
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: CDMA Clinical Trial Lead, Vision Care, Alcon Research, LLC
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)
May 17, 2021
Primary Completion (Actual)
June 27, 2021
Study Completion (Actual)
June 27, 2021
Study Registration Dates
First Submitted
April 26, 2021
First Submitted That Met QC Criteria
April 26, 2021
First Posted (Actual)
April 29, 2021
Study Record Updates
Last Update Posted (Actual)
July 6, 2022
Last Update Submitted That Met QC Criteria
June 9, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLE383-P005
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
Yes
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.
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