Astigmatism
Conditions
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
Interventions
DEVICE1-day toric test contact lens
somofilcon A 1-day toric test contact lens
DEVICE1-day toric control contact lens
somofilcon A 1-day toric control contact lens
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visibility of Toric Mark | 1 hour | Toric Mark visible or not visible. Data for all 4 pairs were combined and analyzed (n=40 contact lenses). |
| Degree of Lens Orientation | Baseline | 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 | 15 minutes | 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). |
| Degree of Rotational Recovery | 15 minutes | 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 | 15 minutes | 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 | Baseline | 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
| Measure | Time frame | Description |
|---|---|---|
| Up Gaze Lag | 15 minutes | Up gaze lag measured in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses). |
| Measurement of Lens Horizontal Centration | 15 Minutes | Measurement of Lens Horizontal Centration in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses). |
| General Lens Fit Preference | Baseline | 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). |
| Measurement of Lens Vertical Centration | 15 minutes | Lens Horizontal centration measured in mm. Data for all 4 pairs were combined and analyzed (n=40 contact lenses). |
| Measurement of Lens Movement | 15 minutes | Measurement of lens movement in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses). |
| Lens Push-Up | 15 minutes | Lens push-up measured in percentage. Data for all 4 pairs were combined and analyzed (n=40 contact lenses). |
| Primary Lens Gaze Lag | 15 minutes | Primary lens gaze lag measured in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses). |
| General Lens Fit Acceptance | 15 minutes | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Total Participants | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Overall Study | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 10 Participants | — |
| Age, Continuous | 25 years STANDARD_DEVIATION 4 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 10 participants | — |
| Sex: Female, Male Female | 8 Participants | — |
| Sex: Female, Male Male | 2 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
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).
Time frame: 1 hour
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Contact Lenses | Degree of Lens Orientation | -1 Degrees | Standard Deviation 6 |
| Control Contact Lenses | Degree of Lens Orientation | -1 Degrees | Standard Deviation 6 |
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).
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Contact Lenses | Degree of Lens Orientation | 0 Degrees | Standard Deviation 7 |
| Control Contact Lenses | Degree of Lens Orientation | -1 Degrees | Standard Deviation 7 |
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).
Time frame: 15 minutes
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Contact Lenses | Degree of Lens Orientation | 1 Degrees | Standard Deviation 6 |
| Control Contact Lenses | Degree of Lens Orientation | 0 Degrees | Standard Deviation 7 |
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).
Time frame: 1 hour
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Contact Lenses | Degree of Rotational Recovery | Nasal | 16 Degrees | Standard Deviation 9 |
| Test Contact Lenses | Degree of Rotational Recovery | Temporal | 9 Degrees | Standard Deviation 10 |
| Control Contact Lenses | Degree of Rotational Recovery | Nasal | 12 Degrees | Standard Deviation 10 |
| Control Contact Lenses | Degree of Rotational Recovery | Temporal | 10 Degrees | Standard Deviation 10 |
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).
Time frame: 15 minutes
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Contact Lenses | Degree of Rotational Recovery | Nasal | 16 Degrees | Standard Deviation 9 |
| Test Contact Lenses | Degree of Rotational Recovery | Temporal | 10 Degrees | Standard Deviation 10 |
| Control Contact Lenses | Degree of Rotational Recovery | Nasal | 15 Degrees | Standard Deviation 10 |
| Control Contact Lenses | Degree of Rotational Recovery | Temporal | 10 Degrees | Standard Deviation 9 |
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).
Time frame: 1 hour
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Contact Lenses | Toric Fit Acceptance | 3.5 units on a scale | Standard Deviation 0.2 |
| Control Contact Lenses | Toric Fit Acceptance | 3.4 units on a scale | Standard Deviation 0.3 |
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).
Time frame: 15 minutes
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Contact Lenses | Toric Fit Acceptance | 3.5 units on a scale | Standard Deviation 0.2 |
| Control Contact Lenses | Toric Fit Acceptance | 3.4 units on a scale | Standard Deviation 0.2 |
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).
Time frame: 1 hour
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Test Contact Lenses | Toric Fit Preference | Test Lens | 33 percentage of eyes |
| Test Contact Lenses | Toric Fit Preference | No Preference | 57 percentage of eyes |
| Test Contact Lenses | Toric Fit Preference | Control Lens | 10 percentage of eyes |
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).
Time frame: Baseline
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Test Contact Lenses | Toric Fit Preference | Test Lens | 23 percentage of eyes |
| Test Contact Lenses | Toric Fit Preference | No Preference | 69 percentage of eyes |
| Test Contact Lenses | Toric Fit Preference | Control Lens | 8 percentage of eyes |
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).
Time frame: 15 minutes
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Contact Lenses | Toric Stability | 4 Degrees | Standard Deviation 3 |
| Control Contact Lenses | Toric Stability | 4 Degrees | Standard Deviation 3 |
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).
Time frame: 1 hour
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Contact Lenses | Toric Stability | 5 Degrees | Standard Deviation 3 |
| Control Contact Lenses | Toric Stability | 4 Degrees | Standard Deviation 3 |
Primary
Visibility of Toric Mark
Toric Mark visible or not visible. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Time frame: 1 hour
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Test Contact Lenses | Visibility of Toric Mark | Visible | 100 percentage of participants |
| Test Contact Lenses | Visibility of Toric Mark | Not Visible | 0 percentage of participants |
| Control Contact Lenses | Visibility of Toric Mark | Visible | 100 percentage of participants |
| Control Contact Lenses | Visibility of Toric Mark | Not Visible | 0 percentage of participants |
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).
Time frame: 1 hour
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Contact Lenses | General Lens Fit Acceptance | 3.4 units on a scale | Standard Deviation 0.2 |
| Control Contact Lenses | General Lens Fit Acceptance | 3.4 units on a scale | Standard Deviation 0.2 |
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).
Time frame: 15 minutes
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Contact Lenses | General Lens Fit Acceptance | 3.4 units on a scale | Standard Deviation 0.2 |
| Control Contact Lenses | General Lens Fit Acceptance | 3.4 units on a scale | Standard Deviation 0.2 |
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).
Time frame: 1 hour
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Test Contact Lenses | General Lens Fit Preference | Test Lens | 3 percentage of eyes |
| Test Contact Lenses | General Lens Fit Preference | No preference | 94 percentage of eyes |
| Test Contact Lenses | General Lens Fit Preference | Control lens | 3 percentage of eyes |
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).
Time frame: Baseline
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Test Contact Lenses | General Lens Fit Preference | Test Lens | 5 percentage of eyes |
| Test Contact Lenses | General Lens Fit Preference | No preference | 92 percentage of eyes |
| Test Contact Lenses | General Lens Fit Preference | Control lens | 3 percentage of eyes |
Secondary
Lens Push-Up
Lens push-up measured in percentage. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Time frame: 15 minutes
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Contact Lenses | Lens Push-Up | 45 percentage | Standard Deviation 6 |
| Control Contact Lenses | Lens Push-Up | 47 percentage | Standard Deviation 6 |
Secondary
Lens Push-Up
Lens push-up measured in percentage. Data for all 4 pairs were combined and analyzed (n=40 control lenses).
Time frame: 1 hour
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Contact Lenses | Lens Push-Up | 47 percentage | Standard Deviation 5 |
| Control Contact Lenses | Lens Push-Up | 47 percentage | Standard Deviation 6 |
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).
Time frame: 1 hour
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Contact Lenses | Measurement of Lens Horizontal Centration | -0.06 millimeters (mm) | Standard Deviation 0.22 |
| Control Contact Lenses | Measurement of Lens Horizontal Centration | -0.08 millimeters (mm) | Standard Deviation 0.21 |
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).
Time frame: 15 Minutes
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Contact Lenses | Measurement of Lens Horizontal Centration | -0.08 millimeters (mm) | Standard Deviation 0.24 |
| Control Contact Lenses | Measurement of Lens Horizontal Centration | -0.05 millimeters (mm) | Standard Deviation 0.21 |
Secondary
Measurement of Lens Movement
Measurement of lens movement in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Time frame: 1 hour
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Contact Lenses | Measurement of Lens Movement | 0.25 millimeters (mm) | Standard Deviation 0.08 |
| Control Contact Lenses | Measurement of Lens Movement | 0.24 millimeters (mm) | Standard Deviation 0.08 |
Secondary
Measurement of Lens Movement
Measurement of lens movement in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Time frame: 15 minutes
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Contact Lenses | Measurement of Lens Movement | 0.26 millimeters (mm) | Standard Deviation 0.09 |
| Control Contact Lenses | Measurement of Lens Movement | 0.25 millimeters (mm) | Standard Deviation 0.08 |
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).
Time frame: 1 hour
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Contact Lenses | Measurement of Lens Vertical Centration | 0.32 millimeters (mm) | Standard Deviation 0.19 |
| Control Contact Lenses | Measurement of Lens Vertical Centration | 0.27 millimeters (mm) | Standard Deviation 0.26 |
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).
Time frame: 15 minutes
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Contact Lenses | Measurement of Lens Vertical Centration | 0.34 millimeters (mm) | Standard Deviation 0.22 |
| Control Contact Lenses | Measurement of Lens Vertical Centration | 0.34 millimeters (mm) | Standard Deviation 0.21 |
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).
Time frame: 1 hour
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Contact Lenses | Primary Lens Gaze Lag | 0.20 millimeters (mm) | Standard Deviation 0.06 |
| Control Contact Lenses | Primary Lens Gaze Lag | 0.19 millimeters (mm) | Standard Deviation 0.08 |
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).
Time frame: 15 minutes
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Contact Lenses | Primary Lens Gaze Lag | 0.20 millimeters (mm) | Standard Deviation 0.08 |
| Control Contact Lenses | Primary Lens Gaze Lag | 0.21 millimeters (mm) | Standard Deviation 0.08 |
Secondary
Up Gaze Lag
Up gaze lag measured in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Time frame: 15 minutes
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Contact Lenses | Up Gaze Lag | 0.25 millimeters (mm) | Standard Deviation 0.1 |
| Control Contact Lenses | Up Gaze Lag | 0.25 millimeters (mm) | Standard Deviation 0.09 |
Secondary
Up Gaze Lag
Up gaze lag measured in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Time frame: 1 hour
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Contact Lenses | Up Gaze Lag | 0.22 millimeters (mm) | Standard Deviation 0.08 |
| Control Contact Lenses | Up Gaze Lag | 0.22 millimeters (mm) | Standard Deviation 0.08 |