- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05805150
Performance Evaluation of Daily Disposable Contact Lenses in Habitual Lens Wearers Who Use Digital Devices Frequently
April 19, 2023 updated by: Coopervision, Inc.
Performance Evaluation of Different Daily Disposable Contact Lenses in Habitual Lens Wearers Who Report Frequent Use of Digital Devices
The goal of this study is to compare the performance of two daily disposable silicone hydrogel lenses.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
This study is prospective, bilateral eye, double masked, randomized, 1 week cross-over, daily wear design involving in two different daily disposable lens types.
Each lens type will be worn for approximately one week.
Study Type
Interventional
Enrollment (Anticipated)
73
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 Contact
- Name: Jose A Vega, OD,MSc,FAAO
- Phone Number: 9256213761
- Email: javega@coopervision.com
Study Locations
-
-
Kansas
-
Pittsburg, Kansas, United States, 66762
- Recruiting
- Kannarr Eye Care
-
Contact:
- Shane Kannarr
-
-
Minnesota
-
Medina, Minnesota, United States, 55340
- Recruiting
- Complete Eye Care of Medina/Complete Vision Solutions
-
Contact:
- Gina Wesley, OD,MS,FAAO
-
-
Pennsylvania
-
State College, Pennsylvania, United States, 16801
- Recruiting
- Nittany Eye Associate
-
Contact:
- Mike Cymbor
-
-
Rhode Island
-
Warwick, Rhode Island, United States, 02888
- Recruiting
- West Bay Associate
-
Contact:
- Stephen M Montaquila
-
-
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 to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Is between 18 and 35 years of age (inclusively) and has full legal capacity to volunteer;
- Has read and signed an information consent letter;
- Self-reports having a full eye examination in the previous two years;
- Self-reports spending on most days at least 6 hours cumulative (not necessarily in one single stretch) using digital devices such as a computer, laptop, tablet, e-reader, smartphone;
- Anticipates being able to wear the study lenses for at least 8 hours a day, 7 days a week;
- Is willing and able to follow instructions and maintain the appointment schedule;
Habitually wears soft contact lenses, for the past 3 months minimum;
- No more than 1/3 of participants should be habitual wearer of MyDay or MyDay Energys
- No more than 1/3 of participants should be habitual wearer of ACUVUE® OASYS MAX 1-Day or ACUVUE® OASYS 1-Day.
- Has refractive astigmatism no higher than -0.75DC in each eye;
- Can be fit and achieve binocular distance vision of at least 20/30 Snellen (Available lens parameters are sphere -1.00 to -6.00D, 0.25D steps).
Exclusion Criteria:
- Is participating in any concurrent clinical or research study;
- Has any known active ocular disease and/or infection that contraindicates contact lens wear;
- Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;
- Has known sensitivity to the diagnostic sodium fluorescein used in the study;
- Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
- Has undergone refractive error surgery or intraocular surgery.
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 |
---|---|
Experimental: Control Contact Lens, Then Test Contact Lens
Participants will wear control contact lenses for one week and then crossover to test contact lenses for one week.
|
One week wear
One week wear
|
Experimental: Test Contact Lens, Then Control Contact Lens
Participants will wear test contact lenses for one week and then crossover to control contact lenses for one week.
|
One week wear
One week wear
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lens Handling on Removal
Time Frame: 6 days of wear
|
Lens Handling on Removal using a 0-100 scale (0= very difficult, 100= very easy)
|
6 days of wear
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Gina Wesley, OD,MS,FAAO, Complete Eye Care of Medina/Complete Vision Solutions
- Principal Investigator: Mike Cymbor, Nittany Eye Associate
- Principal Investigator: Shane Kannarr, Shane Kannarr Eye Care
- Principal Investigator: Stephen M Montaquila, West Bay Eye Associate
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)
February 28, 2023
Primary Completion (Anticipated)
July 31, 2023
Study Completion (Anticipated)
July 31, 2023
Study Registration Dates
First Submitted
March 28, 2023
First Submitted That Met QC Criteria
March 28, 2023
First Posted (Actual)
April 7, 2023
Study Record Updates
Last Update Posted (Actual)
April 21, 2023
Last Update Submitted That Met QC Criteria
April 19, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EX-MKTG-148
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.
Yes
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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