Myopia
Conditions
Brief summary
The primary objective of the study is to evaluate the clinical performance of test lens (Orion) in comparison with control lens (Gemini) over a period of two weeks of wear.
Detailed description
The primary objective of the study is to evaluate the clinical performance of test lens (Orion) in comparison with control lens (Gemini) over a period of two weeks of wear. This is a double-masked, randomized, bilateral, two-week crossover, dispensing study.
Interventions
DEVICEOrion daily disposable contact lens
Subjects will be randomized to wear Orion lens for 2 weeks.
DEVICEGemini daily disposable contact lens
Subjects will be randomized to wear Gemini lens for 2 weeks.
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Is at least 18 years of age and has full legal capacity to volunteer. * Is no greater than 55 years of age. * Has read and understood the information consent letter. * Is willing and able to follow instructions and maintain the appointment schedule. * Is an adapted soft contact lens wearer having worn lenses for a minimum of 4 weeks prior to the study. * Has spectacle cylinder ≤1.00D in both eyes. * Has spherical contact lens power requirement between -1.00D and -6.00D in both eyes. * Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/20 in each eye. * Wears CLs in both eyes (monovision acceptable, but not monofit) * Has clear corneas and no active ocular disease. * Has not worn lenses for at least 12 hours before the examination. * Is willing to wear the study contact lenses for a minimum 8 hours per day/6 days per week
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 strabismus/amblyopia. * Has undergone corneal refractive surgery. * Is pregnant, lactating or planning a pregnancy. * Is participating in any concurrent clinical or research study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Response for Vision Satisfaction | Baseline - After 10 minutes of lens dispense | Subjective Response for Vision Satisfaction assessed on 7-point Likert (Very satisfied, Satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied) |
| Subjective Response for Overall Vision Satisfaction | 2 Weeks | Subjective Response for Vision satisfaction assessed on 7-point Likert (Very satisfied, Satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied) |
| Subjective Response for Overall Vision Quality | Baseline - After 10 minutes of lens dispense | Subjective Response for Overall Vision quality assessed on a 0-100 scale (0- Unacceptable, 100- Excellent Vision) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Horizontal Lens Centration | Baseline - After 10 minutes of lens dispense | Horizontal Lens Centration assessed in primary gaze, white light, diffuse, low-medium magnification, with graticule on 0.1mm steps (Nasal decentration given +ve value. temporal decentration given -ve value) |
| Vertical Lens Centration | Baseline - After 10 minutes of lens dispense | Vertical Lens Centration assessed in primary gaze, white light, diffuse, low-medium magnification, with graticule on 0.1mm steps (Superior decentration given +ve value, inferior decentration given -ve value) |
| Post-blink Movement | Baseline - after 10 minutes of lens dispense | Post-blink movement assessed on the amount of lens movement to the nearest 0.1mm immediately after the blink |
| Lens Horizontal Mobility Rating | Baseline - after 10 minutes of lens dispense | Lens Horizontal Mobility Rating on a scale of 0-4 (0-immobile, 1- restricted, 2- secure, 3- unrestricted, 4- very mobile) |
| Subjective Overall Comfort Satisfaction | Baseline - After 10 minutes of lens dispense | Overall comfort satisfaction analyzed on 7-point Likert (Very satisfied, Satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied) |
| Overall Lens Fit Acceptance | Baseline - after 10 minutes of lens dispense | Overall Lens Fit Acceptance assessed on a scale of 0-4 (0-Can't be worn, 1- Poor but acceptable, 2- Fair, 3- Good, 4- Optimum) |
| Lens Handling Satisfaction | 2 weeks | Lens handling satisfaction assessed on a 7-point Likert Scales (Very satisfied, satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied) |
| Subjective Overall Lens Handling | 2 weeks | SubjectiveOverall Lens handling assessed on a scale of 0-100 (0- cannot be managed, 100- Excellent handling) |
| Corneal Staining Extent | Baseline - after 10 minutes of lens dispense | Corneal staining extent will be assessed on a scale of 0-4 (0- No Staining, 1- 1 to 15% of area, 2- 16 to 30% of area, 3- 31-45% of area, 4- \>45% of area). |
| Subjective Preference for Comfort | 2 weeks | Subjective preference for comfort (Orion strongly, Orion slightly, No preference, Gemini slightly, Gemini strongly) |
| Lens Surface Wettability Performance | Baseline - After 10 minutes of lens dispense | Lens Surface wettability performance was measured on a scale of 0-4, 0.25 steps (0-Very poor, 1 - Poor, 2- Acceptable, 3- Good, 4- Excellent) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Subjects were randomized to wear Orion daily disposable contact lenses for 2 weeks and then Gemini daily disposable contact lenses for 2 weeks in this randomized, cross-over bilateral dispensing study.
Orion daily disposable contact lens Gemini daily disposable contact lens | 64 |
| Total | 64 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention | Lost to Follow-up | 0 | 3 |
| First Intervention | Physician Decision | 1 | 0 |
| First Intervention | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Overall Study | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 64 Participants | — |
| Age, Continuous | 23 years STANDARD_DEVIATION 4 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 64 participants | — |
| Sex: Female, Male Female | 49 Participants | — |
| Sex: Female, Male Male | 15 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 64 | 0 / 64 |
| other Total, other adverse events | 0 / 64 | 0 / 64 |
| serious Total, serious adverse events | 0 / 64 | 0 / 64 |
Outcome results
Primary
Subjective Response for Overall Vision Quality
Subjective Response for Overall Vision quality assessed on a 0-100 scale (0- Unacceptable, 100- Excellent Vision)
Time frame: Baseline - After 10 minutes of lens dispense
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Orion | Subjective Response for Overall Vision Quality | 90 units on a scale | Standard Deviation 8 |
| Gemini | Subjective Response for Overall Vision Quality | 91 units on a scale | Standard Deviation 9 |
Primary
Subjective Response for Overall Vision Quality
Subjective Response for Overall Vision Quality assessed on a 0-100 scale (0- Unacceptable, 100- Excellent Vision)
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Orion | Subjective Response for Overall Vision Quality | 86 units on a scale | Standard Deviation 16 |
| Gemini | Subjective Response for Overall Vision Quality | 89 units on a scale | Standard Deviation 10 |
Primary
Subjective Response for Overall Vision Quality
Subjective Response for Overall Vision Quality assessed on a 0-100 scale (0- Unacceptable, 100- Excellent Vision)
Time frame: 2 weeks - Night Driving
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Orion | Subjective Response for Overall Vision Quality | 87 units on a scale | Standard Deviation 13 |
| Gemini | Subjective Response for Overall Vision Quality | 88 units on a scale | Standard Deviation 10 |
Primary
Subjective Response for Overall Vision Satisfaction
Subjective Response for Vision satisfaction assessed on 7-point Likert (Very satisfied, Satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied)
Time frame: 2 Weeks - at night
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Orion | Subjective Response for Overall Vision Satisfaction | Dissatisfied | 0 percentage of participants |
| Orion | Subjective Response for Overall Vision Satisfaction | Very Dissatisfied | 0 percentage of participants |
| Orion | Subjective Response for Overall Vision Satisfaction | Very satisfied | 42 percentage of participants |
| Orion | Subjective Response for Overall Vision Satisfaction | Satisfied | 41 percentage of participants |
| Orion | Subjective Response for Overall Vision Satisfaction | Somewhat Satisfied | 8 percentage of participants |
| Orion | Subjective Response for Overall Vision Satisfaction | Neither | 7 percentage of participants |
| Orion | Subjective Response for Overall Vision Satisfaction | Somewhat Dissatisfied | 2 percentage of participants |
| Gemini | Subjective Response for Overall Vision Satisfaction | Somewhat Satisfied | 10 percentage of participants |
| Gemini | Subjective Response for Overall Vision Satisfaction | Somewhat Dissatisfied | 5 percentage of participants |
| Gemini | Subjective Response for Overall Vision Satisfaction | Dissatisfied | 0 percentage of participants |
| Gemini | Subjective Response for Overall Vision Satisfaction | Satisfied | 48 percentage of participants |
| Gemini | Subjective Response for Overall Vision Satisfaction | Very Dissatisfied | 0 percentage of participants |
| Gemini | Subjective Response for Overall Vision Satisfaction | Neither | 3 percentage of participants |
| Gemini | Subjective Response for Overall Vision Satisfaction | Very satisfied | 34 percentage of participants |
Primary
Subjective Response for Overall Vision Satisfaction
Subjective Response for Vision satisfaction assessed on 7-point Likert (Very satisfied, Satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied)
Time frame: 2 Weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Orion | Subjective Response for Overall Vision Satisfaction | Somewhat Satisfied | 7 Participants |
| Orion | Subjective Response for Overall Vision Satisfaction | Somewhat Dissatisfied | 3 Participants |
| Orion | Subjective Response for Overall Vision Satisfaction | Satisfied | 22 Participants |
| Orion | Subjective Response for Overall Vision Satisfaction | Dissatisfied | 1 Participants |
| Orion | Subjective Response for Overall Vision Satisfaction | Neither | 0 Participants |
| Orion | Subjective Response for Overall Vision Satisfaction | Very Dissatisfied | 0 Participants |
| Orion | Subjective Response for Overall Vision Satisfaction | Very satisfied | 26 Participants |
| Gemini | Subjective Response for Overall Vision Satisfaction | Very Dissatisfied | 0 Participants |
| Gemini | Subjective Response for Overall Vision Satisfaction | Very satisfied | 28 Participants |
| Gemini | Subjective Response for Overall Vision Satisfaction | Satisfied | 24 Participants |
| Gemini | Subjective Response for Overall Vision Satisfaction | Somewhat Satisfied | 5 Participants |
| Gemini | Subjective Response for Overall Vision Satisfaction | Neither | 1 Participants |
| Gemini | Subjective Response for Overall Vision Satisfaction | Somewhat Dissatisfied | 1 Participants |
| Gemini | Subjective Response for Overall Vision Satisfaction | Dissatisfied | 0 Participants |
Primary
Subjective Response for Vision Satisfaction
Subjective Response for Vision Satisfaction assessed on 7-point Likert (Very satisfied, Satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied)
Time frame: Baseline - After 10 minutes of lens dispense
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Orion | Subjective Response for Vision Satisfaction | Satisfied | 30 Participants |
| Orion | Subjective Response for Vision Satisfaction | Neither | 1 Participants |
| Orion | Subjective Response for Vision Satisfaction | Very satisfied | 24 Participants |
| Orion | Subjective Response for Vision Satisfaction | Somewhat Dissatisfied | 0 Participants |
| Orion | Subjective Response for Vision Satisfaction | Somewhat Satisfied | 4 Participants |
| Orion | Subjective Response for Vision Satisfaction | Dissatisfied | 0 Participants |
| Orion | Subjective Response for Vision Satisfaction | Very Dissatisfied | 0 Participants |
| Gemini | Subjective Response for Vision Satisfaction | Dissatisfied | 0 Participants |
| Gemini | Subjective Response for Vision Satisfaction | Very Dissatisfied | 0 Participants |
| Gemini | Subjective Response for Vision Satisfaction | Very satisfied | 28 Participants |
| Gemini | Subjective Response for Vision Satisfaction | Satisfied | 24 Participants |
| Gemini | Subjective Response for Vision Satisfaction | Somewhat Satisfied | 7 Participants |
| Gemini | Subjective Response for Vision Satisfaction | Neither | 0 Participants |
| Gemini | Subjective Response for Vision Satisfaction | Somewhat Dissatisfied | 0 Participants |
Secondary
Corneal Staining Extent
Corneal staining extent will be assessed on a scale of 0-4 (0- No Staining, 1- 1 to 15% of area, 2- 16 to 30% of area, 3- 31-45% of area, 4- \>45% of area).
Time frame: 2 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Orion | Corneal Staining Extent | Nasal | 0.02 units on a scale | Standard Deviation 0.13 |
| Orion | Corneal Staining Extent | Superior | 0.00 units on a scale | Standard Deviation 0 |
| Orion | Corneal Staining Extent | Temporal | 0.00 units on a scale | Standard Deviation 0 |
| Orion | Corneal Staining Extent | Inferior | 0.01 units on a scale | Standard Deviation 0.38 |
| Orion | Corneal Staining Extent | Central | 0.00 units on a scale | Standard Deviation 0 |
| Gemini | Corneal Staining Extent | Inferior | 0.15 units on a scale | Standard Deviation 0.39 |
| Gemini | Corneal Staining Extent | Central | 0.00 units on a scale | Standard Deviation 0 |
| Gemini | Corneal Staining Extent | Nasal | 0.01 units on a scale | Standard Deviation 0.09 |
| Gemini | Corneal Staining Extent | Temporal | 0.00 units on a scale | Standard Deviation 0 |
| Gemini | Corneal Staining Extent | Superior | 0.00 units on a scale | Standard Deviation 0 |
Secondary
Corneal Staining Extent
Corneal staining extent will be assessed on a scale of 0-4 (0- No Staining, 1- 1 to 15% of area, 2- 16 to 30% of area, 3- 31-45% of area, 4- \>45% of area).
Time frame: Baseline - after 10 minutes of lens dispense
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Orion | Corneal Staining Extent | Nasal | 0.01 units on a scale | Standard Deviation 0.09 |
| Orion | Corneal Staining Extent | Superior | 0.00 units on a scale | Standard Deviation 0 |
| Orion | Corneal Staining Extent | Temporal | 000 units on a scale | Standard Deviation 0 |
| Orion | Corneal Staining Extent | Inferior | 0.01 units on a scale | Standard Deviation 0.09 |
| Orion | Corneal Staining Extent | Central | 0.00 units on a scale | Standard Deviation 0 |
| Gemini | Corneal Staining Extent | Inferior | 0.01 units on a scale | Standard Deviation 0.09 |
| Gemini | Corneal Staining Extent | Central | 0.00 units on a scale | Standard Deviation 0 |
| Gemini | Corneal Staining Extent | Nasal | 0.01 units on a scale | Standard Deviation 0.09 |
| Gemini | Corneal Staining Extent | Temporal | 0.00 units on a scale | Standard Deviation 0 |
| Gemini | Corneal Staining Extent | Superior | 0.00 units on a scale | Standard Deviation 0 |
Secondary
Horizontal Lens Centration
Horizontal Lens Centration assessed in primary gaze, white light, diffuse, low-medium magnification, with graticule on 0.1mm steps (Nasal decentration given +ve value. temporal decentration given -ve value)
Time frame: Baseline - After 10 minutes of lens dispense
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Orion | Horizontal Lens Centration | -0.12 mm | Standard Deviation 0.25 |
| Gemini | Horizontal Lens Centration | -0.18 mm | Standard Deviation 0.26 |
Secondary
Horizontal Lens Centration
Horizontal Lens Centration assessed in primary gaze, white light, diffuse, low-medium magnification, with graticule on 0.1mm steps (Nasal decentration given +ve value. temporal decentration given -ve value)
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Orion | Horizontal Lens Centration | -0.13 mm | Standard Deviation 0.27 |
| Gemini | Horizontal Lens Centration | -0.17 mm | Standard Deviation 0.27 |
Secondary
Lens Handling Satisfaction
Lens handling satisfaction assessed on a 7-point Likert Scales (Very satisfied, satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied)
Time frame: 2 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Orion | Lens Handling Satisfaction | Somewhat Dissatisfied | 1 Participants |
| Orion | Lens Handling Satisfaction | satisfied | 20 Participants |
| Orion | Lens Handling Satisfaction | Somewhat satisfied | 8 Participants |
| Orion | Lens Handling Satisfaction | Neither | 2 Participants |
| Orion | Lens Handling Satisfaction | Very satisfied | 27 Participants |
| Orion | Lens Handling Satisfaction | Dissatisfied | 1 Participants |
| Orion | Lens Handling Satisfaction | Very Dissatisfied | 0 Participants |
| Gemini | Lens Handling Satisfaction | Very Dissatisfied | 0 Participants |
| Gemini | Lens Handling Satisfaction | Somewhat Dissatisfied | 3 Participants |
| Gemini | Lens Handling Satisfaction | Very satisfied | 14 Participants |
| Gemini | Lens Handling Satisfaction | Dissatisfied | 1 Participants |
| Gemini | Lens Handling Satisfaction | satisfied | 27 Participants |
| Gemini | Lens Handling Satisfaction | Neither | 3 Participants |
| Gemini | Lens Handling Satisfaction | Somewhat satisfied | 11 Participants |
Secondary
Lens Horizontal Mobility Rating
Lens Horizontal Mobility Rating on a scale of 0-4 (0-immobile, 1- restricted, 2- secure, 3- unrestricted, 4- very mobile)
Time frame: Baseline - after 10 minutes of lens dispense
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Orion | Lens Horizontal Mobility Rating | 2.36 units on a scale | Standard Deviation 0.3 |
| Gemini | Lens Horizontal Mobility Rating | 2.33 units on a scale | Standard Deviation 0.29 |
Secondary
Lens Horizontal Mobility Rating
Lens Horizontal Mobility Rating on a scale of 0-4 (0-immobile, 1- restricted, 2- secure, 3- unrestricted, 4- very mobile)
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Orion | Lens Horizontal Mobility Rating | 2.36 units on a scale | Standard Deviation 0.28 |
| Gemini | Lens Horizontal Mobility Rating | 2.41 units on a scale | Standard Deviation 0.31 |
Secondary
Lens Surface Wettability Performance
Lens Surface wettability performance was measured on a scale of 0-4, 0.25 steps (0-Very poor, 1 - Poor, 2- Acceptable, 3- Good, 4- Excellent)
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Orion | Lens Surface Wettability Performance | 3.31 units on a scale | Standard Deviation 0.41 |
| Gemini | Lens Surface Wettability Performance | 3.40 units on a scale | Standard Deviation 0.38 |
Secondary
Lens Surface Wettability Performance
Lens Surface wettability performance was measured on a scale of 0-4, 0.25 steps (0-Very poor, 1 - Poor, 2- Acceptable, 3- Good, 4- Excellent)
Time frame: Baseline - After 10 minutes of lens dispense
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Orion | Lens Surface Wettability Performance | 3.40 units on a scale | Standard Deviation 0.36 |
| Gemini | Lens Surface Wettability Performance | 3.32 units on a scale | Standard Deviation 0.4 |
Secondary
Overall Lens Fit Acceptance
Overall Lens Fit Acceptance assessed on a scale of 0-4 (0-Can't be worn, 1- Poor but acceptable, 2- Fair, 3- Good, 4- Optimum)
Time frame: Baseline - after 10 minutes of lens dispense
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Orion | Overall Lens Fit Acceptance | 3.20 units on a scale | Standard Deviation 0.32 |
| Gemini | Overall Lens Fit Acceptance | 3.11 units on a scale | Standard Deviation 0.32 |
Secondary
Overall Lens Fit Acceptance
Overall Lens Fit Acceptance assessed on a scale of 0-4 (0-Can't be worn, 1- Poor but acceptable, 2- Fair, 3- Good, 4- Optimum)
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Orion | Overall Lens Fit Acceptance | 3.22 units on a scale | Standard Deviation 0.34 |
| Gemini | Overall Lens Fit Acceptance | 3.11 units on a scale | Standard Deviation 0.39 |
Secondary
Post-blink Movement
Post-blink movement assessed on the amount of lens movement to the nearest 0.1mm immediately after the blink
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Orion | Post-blink Movement | 0.29 mm | Standard Deviation 0.08 |
| Gemini | Post-blink Movement | 0.32 mm | Standard Deviation 0.09 |
Secondary
Post-blink Movement
Post-blink movement assessed on the amount of lens movement to the nearest 0.1mm immediately after the blink
Time frame: Baseline - after 10 minutes of lens dispense
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Orion | Post-blink Movement | 0.28 mm | Standard Deviation 0.08 |
| Gemini | Post-blink Movement | 0.29 mm | Standard Deviation 0.09 |
Secondary
Subjective Overall Comfort Satisfaction
Overall comfort satisfaction analyzed on 7-point Likert (Very satisfied, Satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied)
Time frame: 2 Weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Orion | Subjective Overall Comfort Satisfaction | Satisfied | 25 Participants |
| Orion | Subjective Overall Comfort Satisfaction | Neither | 0 Participants |
| Orion | Subjective Overall Comfort Satisfaction | Very satisfied | 22 Participants |
| Orion | Subjective Overall Comfort Satisfaction | Somewhat Dissatisfied | 4 Participants |
| Orion | Subjective Overall Comfort Satisfaction | Somewhat satisfied | 6 Participants |
| Orion | Subjective Overall Comfort Satisfaction | Dissatisfied | 2 Participants |
| Orion | Subjective Overall Comfort Satisfaction | Very Dissatisfied | 0 Participants |
| Gemini | Subjective Overall Comfort Satisfaction | Dissatisfied | 3 Participants |
| Gemini | Subjective Overall Comfort Satisfaction | Very Dissatisfied | 0 Participants |
| Gemini | Subjective Overall Comfort Satisfaction | Very satisfied | 17 Participants |
| Gemini | Subjective Overall Comfort Satisfaction | Satisfied | 19 Participants |
| Gemini | Subjective Overall Comfort Satisfaction | Somewhat satisfied | 14 Participants |
| Gemini | Subjective Overall Comfort Satisfaction | Neither | 2 Participants |
| Gemini | Subjective Overall Comfort Satisfaction | Somewhat Dissatisfied | 4 Participants |
Secondary
Subjective Overall Comfort Satisfaction
Overall comfort satisfaction analyzed on 7-point Likert (Very satisfied, Satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied)
Time frame: Baseline - After 10 minutes of lens dispense
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Orion | Subjective Overall Comfort Satisfaction | Somewhat satisfied | 7 Participants |
| Orion | Subjective Overall Comfort Satisfaction | Somewhat Dissatisfied | 0 Participants |
| Orion | Subjective Overall Comfort Satisfaction | Satisfied | 20 Participants |
| Orion | Subjective Overall Comfort Satisfaction | Dissatisfied | 0 Participants |
| Orion | Subjective Overall Comfort Satisfaction | Neither | 0 Participants |
| Orion | Subjective Overall Comfort Satisfaction | Very Dissatisfied | 0 Participants |
| Orion | Subjective Overall Comfort Satisfaction | Very satisfied | 32 Participants |
| Gemini | Subjective Overall Comfort Satisfaction | Very Dissatisfied | 0 Participants |
| Gemini | Subjective Overall Comfort Satisfaction | Very satisfied | 31 Participants |
| Gemini | Subjective Overall Comfort Satisfaction | Satisfied | 22 Participants |
| Gemini | Subjective Overall Comfort Satisfaction | Somewhat satisfied | 6 Participants |
| Gemini | Subjective Overall Comfort Satisfaction | Neither | 0 Participants |
| Gemini | Subjective Overall Comfort Satisfaction | Somewhat Dissatisfied | 0 Participants |
| Gemini | Subjective Overall Comfort Satisfaction | Dissatisfied | 0 Participants |
Secondary
Subjective Overall Lens Handling
SubjectiveOverall Lens handling assessed on a scale of 0-100 (0- cannot be managed, 100- Excellent handling)
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Orion | Subjective Overall Lens Handling | 87 units on a scale | Standard Deviation 14 |
| Gemini | Subjective Overall Lens Handling | 83 units on a scale | Standard Deviation 16 |
Secondary
Subjective Preference for Comfort
Subjective preference for comfort (Orion strongly, Orion slightly, No preference, Gemini slightly, Gemini strongly)
Time frame: 2 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Orion | Subjective Preference for Comfort | Orion strongly | 13 Participants |
| Orion | Subjective Preference for Comfort | Orion slightly | 21 Participants |
| Orion | Subjective Preference for Comfort | No preference | 10 Participants |
| Orion | Subjective Preference for Comfort | Gemini slightly | 7 Participants |
| Orion | Subjective Preference for Comfort | Gemini strongly | 8 Participants |
Secondary
Vertical Lens Centration
Vertical Lens Centration assessed in primary gaze, white light, diffuse, low-medium magnification, with graticule on 0.1mm steps (Superior decentration given +ve value, inferior decentration given -ve value)
Time frame: Baseline - After 10 minutes of lens dispense
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Orion | Vertical Lens Centration | 0.03 mm | Standard Deviation 27 |
| Gemini | Vertical Lens Centration | 0.06 mm | Standard Deviation 0.29 |
Secondary
Vertical Lens Centration
Vertical Lens Centration assessed in primary gaze, white light, diffuse, low-medium magnification, with graticule on 0.1mm steps (Superior decentration given +ve value, inferior decentration given -ve value)
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Orion | Vertical Lens Centration | 0.09 mm | Standard Deviation 0.27 |
| Gemini | Vertical Lens Centration | 0.12 mm | Standard Deviation 0.32 |