Back to resultsClinical Evaluation of Two Daily Disposable Lenses in Sphere Design
Primary Purpose
Ametropia
Status
Recruiting
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Lens A
Lens B
Sponsored by
About this trial
This is an interventional treatment trial for Ametropia
Eligibility Criteria
Inclusion Criteria:
- Is at least 18 years of age 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.
- Anticipates being able to wear the study lenses for the required time of the study.
- Is willing and able to follow instructions and maintain the appointment schedule.
- Has refractive astigmatism no higher than -0.75 DC.
- Can be fit with the available lens parameters (sphere +8.00 to -10.00D).
- Can achieve binocular distance vision of at least 20/30 Snellen (logMAR 0.18) with the study contact lenses.
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.
Sites / Locations
- Dr. Ruben Velazquez Private PracticeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Lens A
Lens B
Arm Description
Participants will wear Lens A for 15 minutes and then cross-over to Lens B for 15 minutes.
Participants will wear Lens B for 15 minutes.
Outcomes
Primary Outcome Measures
Overall Lens Fit Acceptance
Overall Lens Fit Acceptance based on lens fit alone will be measured on a scale of 0 - 4 (0 = Should not be worn, 1 = Borderline but unacceptable, 2 = Min. acceptable, early review, 3 = Not perfect but OK to dispense, 4 = Perfect)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05516082
Brief Title
Clinical Evaluation of Two Daily Disposable Lenses in Sphere Design
Official Title
Clinical Evaluation of Two Daily Disposable Lenses in Sphere Design
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 2022 (Anticipated)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coopervision, Inc.
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.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to evaluate the patient subjective experiences of the daily disposable hydrogel lens when compared to the daily disposable silicone hydrogel lens after 15 minutes of daily wear each.
Detailed Description
This is a single-blind, (participant masked), interventional, prospective, direct refit, bilateral wear study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ametropia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lens A
Arm Type
Experimental
Arm Description
Participants will wear Lens A for 15 minutes and then cross-over to Lens B for 15 minutes.
Arm Title
Lens B
Arm Type
Active Comparator
Arm Description
Participants will wear Lens B for 15 minutes.
Intervention Type
Device
Intervention Name(s)
Lens A
Intervention Description
daily disposable hydrogel contact lens - Test Lens 15 minutes of daily wear
Intervention Type
Device
Intervention Name(s)
Lens B
Intervention Description
daily disposable silicone hydrogel contact lens - Control Lens 15 minutes of daily wear
Primary Outcome Measure Information:
Title
Overall Lens Fit Acceptance
Description
Overall Lens Fit Acceptance based on lens fit alone will be measured on a scale of 0 - 4 (0 = Should not be worn, 1 = Borderline but unacceptable, 2 = Min. acceptable, early review, 3 = Not perfect but OK to dispense, 4 = Perfect)
Time Frame
15 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Is at least 18 years of age 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.
Anticipates being able to wear the study lenses for the required time of the study.
Is willing and able to follow instructions and maintain the appointment schedule.
Has refractive astigmatism no higher than -0.75 DC.
Can be fit with the available lens parameters (sphere +8.00 to -10.00D).
Can achieve binocular distance vision of at least 20/30 Snellen (logMAR 0.18) with the study contact lenses.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
José A Vega, OD,MSc,FAAO
Phone
925-621-3761
Email
javega@coopervision.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rubén V Guerrero, MSc., FIACLE
Organizational Affiliation
Dr. Ruben Velazquez Private Practice
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Ruben Velazquez Private Practice
City
Mexico City
ZIP/Postal Code
06700
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rubén V Guerrero
12. IPD Sharing Statement
Learn more about this trial
Clinical Evaluation of Two Daily Disposable Lenses in Sphere Design
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