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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1-day toric test contact lens | Experimental | 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). |
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| 1-day toric control contact lens | Active Comparator | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1-day toric test contact lens | Device | somofilcon A 1-day toric test contact lens |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pete S Kollbaum, OD PhD | Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University | Bloomington | Indiana | 47405 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Contact Lenses / Control Contact Lenses | Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye for 1 hour. Four different powers of test and control lens were used. There was a 15-minute wash-out period between the two lens pairs 1-day toric test contact lens 1: Invigor 1-day toric test contact lens -1.00 -1.75 x 180, -1.00 -1.75 x 090, -6.00 -1.75 x 180, -6.00 -1.75 x 090 1-day toric control contact lens 1: somofilcon A 1-day toric control contact lens -1.00 -1.75 x 180, -1.00 -1.75 x 090, -6.00 -1.75 x 180, -6.00 -1.75 x 090 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pair 1 Test / Control Dispense |
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| Pair 1 Test /Control Follow up |
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| Pair 2 Test / Control Dispense |
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| Pair 2 Test /Control Follow up |
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| Pair 3 Test / Control Dispense |
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| Pair 3 Test /Control Follow up |
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| Pair 4 Test / Control Dispense |
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| Pair 4 Test /Control Follow up |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Total Participants |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visibility of Toric Mark | Toric Mark visible or not visible. Data for all 4 pairs were combined and analyzed (n=40 contact lenses). | The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses. | Posted | Number | percentage of participants | 1 hour | Contact Lenses | Contact Lenses |
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From dispense up to 1 hour on each pair of lenses.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test Contact Lenses | Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and the data was combined as the primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses. 1-day toric test contact lens -1.00 -1.75 x 180, -1.00 -1.75 x 090, -6.00 -1.75 x 180, -6.00 -1.75 x 090 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Myhanh Nguyen | CooperVision, Inc. | 925-730-6716 | mnguyen@coopervision.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 18, 2019 | May 13, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D003261 | Contact Lenses |
| ID | Term |
|---|---|
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
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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.
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| 1-day toric control contact lens | Device | somofilcon A 1-day toric control contact lens |
|
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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 |
| 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 |
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 |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Control Contact Lenses | Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and all the data was combined. 1-day toric control contact lens: somofilcon A 1-day toric control contact lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses). |
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| Primary | 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). | The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses. | Posted | Mean | Standard Deviation | Degrees | Baseline | Contact Lenses | Contact Lenses |
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| Primary | 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). | The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses. | Posted | Mean | Standard Deviation | Degrees | 15 minutes | Contact Lenses | Contact Lenses |
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| Primary | 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). | The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses. | Posted | Mean | Standard Deviation | Degrees | 1 hour | Contact lenses | Contact lenses |
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| Primary | 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). | The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses. | Posted | Mean | Standard Deviation | Degrees | 15 minutes | Contact Lenses | Contact Lenses |
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| Primary | 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). | The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses. | Posted | Mean | Standard Deviation | Degrees | 1 hour | Contact lenses | Contact lenses |
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| Primary | 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). | The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses. | Posted | Mean | Standard Deviation | Degrees | 15 minutes | contact lenses | contact lenses |
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| Primary | 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). | The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses. | Posted | Mean | Standard Deviation | Degrees | 1 hour | Contact lenses | Contact lenses |
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| Primary | 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). | The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses. | Posted | Mean | Standard Deviation | units on a scale | 15 minutes | Contact Lenses | Contact Lenses |
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| Primary | 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). | The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses. | Posted | Mean | Standard Deviation | units on a scale | 1 hour | Contact Lenses | Contact Lenses |
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| Primary | 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). | The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses. | Posted | Number | percentage of eyes | Baseline | Contact Lenses | Contact Lenses |
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| Primary | 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). | The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses. | Posted | Number | percentage of eyes | 1 hour | Contact Lenses | Contact Lenses |
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| Secondary | 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). | The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses. | Posted | Mean | Standard Deviation | millimeters (mm) | 15 Minutes | Contact Lenses | Contact Lenses |
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| Secondary | 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). | The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses. | Posted | Mean | Standard Deviation | millimeters (mm) | 1 hour | Contact lenses | Contact lenses |
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| Secondary | Measurement of Lens Vertical Centration | Lens Horizontal centration measured in mm. Data for all 4 pairs were combined and analyzed (n=40 contact lenses). | The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses. | Posted | Mean | Standard Deviation | millimeters (mm) | 15 minutes | Contact lenses | Contact lenses |
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| Secondary | Measurement of Lens Vertical Centration | Lens Horizontal centration measured in mm. Data for all 4 pairs were combined and analyzed (n=40 contact lenses). | The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses. | Posted | Mean | Standard Deviation | millimeters (mm) | 1 hour | Contact lenses | Contact lenses |
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| Secondary | Measurement of Lens Movement | Measurement of lens movement in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses). | The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses. | Posted | Mean | Standard Deviation | millimeters (mm) | 15 minutes | contact lenses | contact lenses |
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| Secondary | Measurement of Lens Movement | Measurement of lens movement in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses). | The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses. | Posted | Mean | Standard Deviation | millimeters (mm) | 1 hour | Contact Lenses | Contact Lenses |
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| Secondary | Lens Push-Up | Lens push-up measured in percentage. Data for all 4 pairs were combined and analyzed (n=40 contact lenses). | The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses. | Posted | Mean | Standard Deviation | percentage | 15 minutes | Contact lenses | Contact lenses |
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| Secondary | Lens Push-Up | Lens push-up measured in percentage. Data for all 4 pairs were combined and analyzed (n=40 control lenses). | The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses. | Posted | Mean | Standard Deviation | percentage | 1 hour | Contact Lenses | Contact Lenses |
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| Secondary | Primary Lens Gaze Lag | Primary lens gaze lag measured in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses). | The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses. | Posted | Mean | Standard Deviation | millimeters (mm) | 15 minutes | Contact lenses | Contact lenses |
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| Secondary | Primary Lens Gaze Lag | Primary lens gaze lag measured in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses). | The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses. | Posted | Mean | Standard Deviation | millimeters (mm) | 1 hour | Contact lenses | Contact lenses |
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| Secondary | 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). | The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses. | Posted | Mean | Standard Deviation | units on a scale | 15 minutes | Contact lenses | Contact lenses |
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| Secondary | 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). | The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses. | Posted | Mean | Standard Deviation | units on a scale | 1 hour | Contact lenses | Contact lenses |
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| Secondary | Up Gaze Lag | Up gaze lag measured in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses). | The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses. | Posted | Mean | Standard Deviation | millimeters (mm) | 15 minutes | contact lenses | contact lenses |
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| Secondary | Up Gaze Lag | Up gaze lag measured in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses). | The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses. | Posted | Mean | Standard Deviation | millimeters (mm) | 1 hour | contact lenses | contact lenses |
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| Secondary | 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). | The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses. | Posted | Number | percentage of eyes | Baseline | Contact lenses | Contact lenses |
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| Secondary | 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). | The primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses. | Posted | Number | percentage of eyes | 1 hour | contact lenses | contact lenses |
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| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Control Contact Lenses | Subjects were randomized to wear 1-day toric test lens in one eye and 1-day toric control contact lens in the other eye. Four different powers of test and control contact lenses were used and the data was combined as the primary objective of the study was to validate the clinical performance of test and control contact lenses. The various lens powers and axis of test and control lenses were combined as the primary objective was not to validate different power of test and control lenses. 1-day toric control contact lens -1.00 -1.75 x 180, -1.00 -1.75 x 090, -6.00 -1.75 x 180, -6.00 -1.75 x 090 | 0 | 10 | 0 | 10 | 0 | 10 |
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