Clinical Evaluation of Invigor Toric 1-Day Contact Lenses

Study Overview
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Brief Summary
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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
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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

Official Title
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Clinical Evaluation of Invigor Toric 1-Day Contact Lenses

Conditions
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Astigmatism

Intervention / Treatment
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* Device: 1-day toric test contact lens
* Device: 1-day toric control contact lens


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1-day toric test contact lens<br>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). | Device: 1-day toric test contact lens<br>* somofilcon A 1-day toric test contact lens<br>* Other names: Invigor toric 1-day contact lens;Device: 1-day toric control contact lens<br>* somofilcon A 1-day toric control contact lens<br>* Other names: Control contact lens;|
| Active Comparator: 1-day toric control contact lens<br>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). | Device: 1-day toric test contact lens<br>* somofilcon A 1-day toric test contact lens<br>* Other names: Invigor toric 1-day contact lens;Device: 1-day toric control contact lens<br>* somofilcon A 1-day toric control contact lens<br>* Other names: Control contact lens;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Baseline | 
| 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). | 1 hour | 
| Visibility of Toric Mark | Toric Mark visible or not visible. Data for all 4 pairs were combined and analyzed (n=40 contact lenses). | 1 hour | 
| 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). | Baseline | 
| 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). | 15 minutes | 
| 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). | 1 hour | 
| 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). | 15 minutes | 
| 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). | 1 hour | 
| 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). | 15 minutes | 
| 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). | 1 hour | 
| 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). | 15 minutes | 
| 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). | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 15 Minutes | 
| 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). | 1 hour | 
| Measurement of Lens Vertical Centration | Lens Horizontal centration measured in mm. Data for all 4 pairs were combined and analyzed (n=40 contact lenses). | 15 minutes | 
| Measurement of Lens Vertical Centration | Lens Horizontal centration measured in mm. Data for all 4 pairs were combined and analyzed (n=40 contact lenses). | 1 hour | 
| Measurement of Lens Movement | Measurement of lens movement in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses). | 15 minutes | 
| Measurement of Lens Movement | Measurement of lens movement in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses). | 1 hour | 
| Lens Push-Up | Lens push-up measured in percentage. Data for all 4 pairs were combined and analyzed (n=40 contact lenses). | 15 minutes | 
| Lens Push-Up | Lens push-up measured in percentage. Data for all 4 pairs were combined and analyzed (n=40 control lenses). | 1 hour | 
| Primary Lens Gaze Lag | Primary lens gaze lag measured in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses). | 15 minutes | 
| Primary Lens Gaze Lag | Primary lens gaze lag measured in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses). | 1 hour | 
| 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). | 15 minutes | 
| 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). | 1 hour | 
| Up Gaze Lag | Up gaze lag measured in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses). | 15 minutes | 
| Up Gaze Lag | Up gaze lag measured in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses). | 1 hour | 
| 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). | Baseline | 
| 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). | 1 hour |