Back to resultsClinical Evaluation of Invigor Toric 1-Day Contact Lenses
Primary Purpose
Astigmatism
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
1-day toric test contact lens
1-day toric control contact lens
Sponsored by
About this trial
This is an interventional treatment trial for Astigmatism
Eligibility Criteria
Inclusion Criteria:
- Has had a self-reported oculo-visual examination in the last two years.
- Is at least 18 years of age and has full legal capacity to volunteer.
- Has read and understood the information consent letter.
- Is willing and able to follow instructions and maintain the appointment schedule.
- Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
- Currently wears soft contact lenses.
- Has clear corneas and no active ocular disease.
- Has not worn lenses for at least 12 hours before the examination
Exclusion Criteria:
- Has never worn contact lenses before.
- Has any systemic disease affecting ocular health.
- Is using any systemic or topical medications that will affect ocular health.
- Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
- Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
- Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
- Is aphakic.
- Has undergone corneal refractive surgery.
- Is participating in any other type of eye related clinical or research study.
Sites / Locations
- Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1-day toric test contact lens
1-day toric control contact lens
Arm Description
Each subject will wear the 1-day toric test (Test) lens in one eye and 1-day toric control (Control) contact lens in the other eye. Patient will wear as an unmatched pair, per predetermined randomization schedule (to determine which eye receives the Test or Control contact lens).
Each subject will wear the 1-day toric test (Test) lens in one eye and 1-day toric control (Control) contact lens in the other eye. Patient will wear as an unmatched pair, per predetermined randomization schedule (to determine which eye receives the Test or Control contact lens).
Outcomes
Primary Outcome Measures
Visibility of Toric Mark
Toric Mark visible or not visible. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Degree of Lens Orientation
Average of lens toric mark mislocation from the resting toric mark away from the 6 o'clock position - measured in degrees.
Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Degree of Lens Orientation
Average of lens toric mark mislocation from the resting toric mark away from the 6 o'clock position - measured in degrees.
Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Degree of Lens Orientation
Average of lens toric mark mislocation from the resting toric mark away from the 6 o'clock position - measured in degrees.
Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Toric Stability
Toric stability (maximal and minimal differences between extreme gazes) measured in degrees for up, down, right, and left gazes.
Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Toric Stability
Rotational stability (maximal and minimal differences between extreme gazes) measured in degrees for up, down, right, and left gazes.
Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Degree of Rotational Recovery
Rotational Recovery for nasal and temporal - measured in degrees. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Degree of Rotational Recovery
Rotational Recovery for nasal and temporal - measured in degrees. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Toric Fit Acceptance
Toric fit acceptance and preference scale 0-4 (0 = can't be worn, 4 = optimum). Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Toric Fit Acceptance
Toric fit acceptance and preference scale 0-4 (0 = can't be worn, 4 = optimum). Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Toric Fit Preference
Investigator's toric fitting preference - Test lens , No Preference , Control lens.
Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Toric Fit Preference
Investigator's toric fitting preference - Test lens, No Preference, Control lens.
Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Secondary Outcome Measures
Measurement of Lens Horizontal Centration
Measurement of Lens Horizontal Centration in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Measurement of Lens Horizontal Centration
Measurement of Lens Horizontal Centration in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Measurement of Lens Vertical Centration
Lens Horizontal centration measured in mm. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Measurement of Lens Vertical Centration
Lens Horizontal centration measured in mm. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Measurement of Lens Movement
Measurement of lens movement in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Measurement of Lens Movement
Measurement of lens movement in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Lens Push-Up
Lens push-up measured in percentage. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Lens Push-Up
Lens push-up measured in percentage. Data for all 4 pairs were combined and analyzed (n=40 control lenses).
Primary Lens Gaze Lag
Primary lens gaze lag measured in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Primary Lens Gaze Lag
Primary lens gaze lag measured in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
General Lens Fit Acceptance
General lens fit acceptance and preference scale 0-4 (0 = unacceptable, 4 = optimal).
Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
General Lens Fit Acceptance
General lens fit acceptance and preference scale 0-4 (0 = unacceptable, 4 = optimal).
Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Up Gaze Lag
Up gaze lag measured in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Up Gaze Lag
Up gaze lag measured in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
General Lens Fit Preference
Investigator's general lens fit preference - Test lens, No preference, Control lens.
Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
General Lens Fit Preference
Investigator's general lens fit preference - Test lens, No preference, Control lens.
Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04016623
Brief Title
Clinical Evaluation of Invigor Toric 1-Day Contact Lenses
Official Title
Clinical Evaluation of Invigor Toric 1-Day Contact Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
May 6, 2019 (Actual)
Primary Completion Date
May 15, 2019 (Actual)
Study Completion Date
June 4, 2019 (Actual)
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.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
An evaluation of the clinical performance of the 1-day toric test contact lens compared to the 1-day toric control contact lens over one hour of lens wear.
Detailed Description
A non-dispensing, double-masked, randomized, contralateral study comparing the 1-day toric test contact lens against the 1-day toric control contact lens to evaluate the clinical performance over one hour of lens wear. Each subject will be randomized to wear the test lens in one eye and the control lens in the other eye for each pair of lenses.
Each subject will be asked to wear four pairs of contact lenses in the study
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Astigmatism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
This is a non-dispensing, double-masked, randomized, contralateral study design. Each subject will be randomized to wear the test lens in one eye and the control lens in the other eye.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1-day toric test contact lens
Arm Type
Experimental
Arm Description
Each subject will wear the 1-day toric test (Test) lens in one eye and 1-day toric control (Control) contact lens in the other eye. Patient will wear as an unmatched pair, per predetermined randomization schedule (to determine which eye receives the Test or Control contact lens).
Arm Title
1-day toric control contact lens
Arm Type
Active Comparator
Arm Description
Each subject will wear the 1-day toric test (Test) lens in one eye and 1-day toric control (Control) contact lens in the other eye. Patient will wear as an unmatched pair, per predetermined randomization schedule (to determine which eye receives the Test or Control contact lens).
Intervention Type
Device
Intervention Name(s)
1-day toric test contact lens
Other Intervention Name(s)
Test contact lens, Invigor toric 1-day contact lens
Intervention Description
somofilcon A 1-day toric test contact lens
Intervention Type
Device
Intervention Name(s)
1-day toric control contact lens
Other Intervention Name(s)
Control contact lens
Intervention Description
somofilcon A 1-day toric control contact lens
Primary Outcome Measure Information:
Title
Visibility of Toric Mark
Description
Toric Mark visible or not visible. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Time Frame
1 hour
Title
Degree of Lens Orientation
Description
Average of lens toric mark mislocation from the resting toric mark away from the 6 o'clock position - measured in degrees.
Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Time Frame
Baseline
Title
Degree of Lens Orientation
Description
Average of lens toric mark mislocation from the resting toric mark away from the 6 o'clock position - measured in degrees.
Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Time Frame
15 minutes
Title
Degree of Lens Orientation
Description
Average of lens toric mark mislocation from the resting toric mark away from the 6 o'clock position - measured in degrees.
Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Time Frame
1 hour
Title
Toric Stability
Description
Toric stability (maximal and minimal differences between extreme gazes) measured in degrees for up, down, right, and left gazes.
Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Time Frame
15 minutes
Title
Toric Stability
Description
Rotational stability (maximal and minimal differences between extreme gazes) measured in degrees for up, down, right, and left gazes.
Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Time Frame
1 hour
Title
Degree of Rotational Recovery
Description
Rotational Recovery for nasal and temporal - measured in degrees. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Time Frame
15 minutes
Title
Degree of Rotational Recovery
Description
Rotational Recovery for nasal and temporal - measured in degrees. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Time Frame
1 hour
Title
Toric Fit Acceptance
Description
Toric fit acceptance and preference scale 0-4 (0 = can't be worn, 4 = optimum). Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Time Frame
15 minutes
Title
Toric Fit Acceptance
Description
Toric fit acceptance and preference scale 0-4 (0 = can't be worn, 4 = optimum). Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Time Frame
1 hour
Title
Toric Fit Preference
Description
Investigator's toric fitting preference - Test lens , No Preference , Control lens.
Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Time Frame
Baseline
Title
Toric Fit Preference
Description
Investigator's toric fitting preference - Test lens, No Preference, Control lens.
Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Measurement of Lens Horizontal Centration
Description
Measurement of Lens Horizontal Centration in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Time Frame
15 Minutes
Title
Measurement of Lens Horizontal Centration
Description
Measurement of Lens Horizontal Centration in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Time Frame
1 hour
Title
Measurement of Lens Vertical Centration
Description
Lens Horizontal centration measured in mm. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Time Frame
15 minutes
Title
Measurement of Lens Vertical Centration
Description
Lens Horizontal centration measured in mm. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Time Frame
1 hour
Title
Measurement of Lens Movement
Description
Measurement of lens movement in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Time Frame
15 minutes
Title
Measurement of Lens Movement
Description
Measurement of lens movement in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Time Frame
1 hour
Title
Lens Push-Up
Description
Lens push-up measured in percentage. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Time Frame
15 minutes
Title
Lens Push-Up
Description
Lens push-up measured in percentage. Data for all 4 pairs were combined and analyzed (n=40 control lenses).
Time Frame
1 hour
Title
Primary Lens Gaze Lag
Description
Primary lens gaze lag measured in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Time Frame
15 minutes
Title
Primary Lens Gaze Lag
Description
Primary lens gaze lag measured in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Time Frame
1 hour
Title
General Lens Fit Acceptance
Description
General lens fit acceptance and preference scale 0-4 (0 = unacceptable, 4 = optimal).
Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Time Frame
15 minutes
Title
General Lens Fit Acceptance
Description
General lens fit acceptance and preference scale 0-4 (0 = unacceptable, 4 = optimal).
Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Time Frame
1 hour
Title
Up Gaze Lag
Description
Up gaze lag measured in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Time Frame
15 minutes
Title
Up Gaze Lag
Description
Up gaze lag measured in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Time Frame
1 hour
Title
General Lens Fit Preference
Description
Investigator's general lens fit preference - Test lens, No preference, Control lens.
Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Time Frame
Baseline
Title
General Lens Fit Preference
Description
Investigator's general lens fit preference - Test lens, No preference, Control lens.
Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Has had a self-reported oculo-visual examination in the last two years.
Is at least 18 years of age and has full legal capacity to volunteer.
Has read and understood the information consent letter.
Is willing and able to follow instructions and maintain the appointment schedule.
Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
Currently wears soft contact lenses.
Has clear corneas and no active ocular disease.
Has not worn lenses for at least 12 hours before the examination
Exclusion Criteria:
Has never worn contact lenses before.
Has any systemic disease affecting ocular health.
Is using any systemic or topical medications that will affect ocular health.
Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
Is aphakic.
Has undergone corneal refractive surgery.
Is participating in any other type of eye related clinical or research study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pete S Kollbaum, OD PhD
Organizational Affiliation
Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47405
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Evaluation of Invigor Toric 1-Day Contact Lenses
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