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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orion then Gemini | Experimental | Subjects will be randomized to wear Orion daily disposable contact lens then Gemini daily disposable contact lens for 2 weeks in this randomized, cross-over bilateral dispensing study. |
|
| Gemini then Orion | Experimental | Subjects will be randomized to wear Gemini daily disposable contact lens then Orion daily disposable contact lens for 2 weeks in this randomized, cross-over bilateral dispensing study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orion daily disposable contact lens | Device | Subjects will be randomized to wear Orion lens for 2 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline - After 10 minutes of lens dispense |
| 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) | 2 Weeks |
| 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) | 2 Weeks - at night |
| Subjective Response for Overall Vision Quality | Subjective Response for Overall Vision quality assessed on a 0-100 scale (0- Unacceptable, 100- Excellent Vision) | Baseline - After 10 minutes of lens dispense |
| Subjective Response for Overall Vision Quality | Subjective Response for Overall Vision Quality assessed on a 0-100 scale (0- Unacceptable, 100- Excellent Vision) | 2 weeks |
| Subjective Response for Overall Vision Quality | Subjective Response for Overall Vision Quality assessed on a 0-100 scale (0- Unacceptable, 100- Excellent Vision) | 2 weeks - Night Driving |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline - After 10 minutes of lens dispense |
| Subjective Overall Comfort Satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pete S Kollbaum | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CORL, Indiana University | Bloomington | Indiana | 47405 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Orion Then Gemini | Subjects were randomized to wear Orion daily disposable contact lens then Gemini daily disposable contact lens for 2 weeks in this randomized, cross-over bilateral dispensing study. |
| FG001 | Gemini Then Orion | Subjects were randomized to wear Gemini daily disposable contact lens then Orion daily disposable contact lens for 2 weeks in this randomized, cross-over bilateral dispensing study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| Second Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| 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 | 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) | Posted | Count of Participants | Participants | Baseline - After 10 minutes of lens dispense |
|
From dispense up to 2 weeks on each study lens, a total of 4 weeks,
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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 | Orion | Subjects were randomized to wear Orion daily disposable contact lenses for 2 weeks in this randomized, cross-over bilateral dispensing study. Orion daily disposable contact lens |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lee Hall, PhD | CooperVision, Inc | (925) 251 6684 | lhall@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 | Aug 20, 2020 | Mar 9, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Gemini daily disposable contact lens | Device | Subjects will be randomized to wear Gemini lens for 2 weeks. |
|
Overall comfort satisfaction analyzed on 7-point Likert (Very satisfied, Satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied) |
| 2 Weeks |
| Subjective Preference for Comfort | Subjective preference for comfort (Orion strongly, Orion slightly, No preference, Gemini slightly, Gemini strongly) | 2 weeks |
| 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) | Baseline - After 10 minutes of lens dispense |
| 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) | 2 weeks |
| 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) | Baseline - After 10 minutes of lens dispense |
| 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) | 2 weeks |
| 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) | Baseline - After 10 minutes of lens dispense |
| 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) | 2 weeks |
| Post-blink Movement | Post-blink movement assessed on the amount of lens movement to the nearest 0.1mm immediately after the blink | Baseline - after 10 minutes of lens dispense |
| Post-blink Movement | Post-blink movement assessed on the amount of lens movement to the nearest 0.1mm immediately after the blink | 2 weeks |
| 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) | Baseline - after 10 minutes of lens dispense |
| 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) | 2 weeks |
| 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). | Baseline - after 10 minutes of lens dispense |
| 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). | 2 weeks |
| 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) | Baseline - after 10 minutes of lens dispense |
| 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) | 2 weeks |
| 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) | 2 weeks |
| Subjective Overall Lens Handling | SubjectiveOverall Lens handling assessed on a scale of 0-100 (0- cannot be managed, 100- Excellent handling) | 2 weeks |
| Withdrawal by Subject |
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| NOT COMPLETED |
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| 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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| 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) | Posted | Count of Participants | Participants | 2 Weeks |
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| 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) | Posted | Number | percentage of participants | 2 Weeks - at night |
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| Primary | Subjective Response for Overall Vision Quality | Subjective Response for Overall Vision quality assessed on a 0-100 scale (0- Unacceptable, 100- Excellent Vision) | Posted | Mean | Standard Deviation | units on a scale | Baseline - After 10 minutes of lens dispense |
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| Primary | Subjective Response for Overall Vision Quality | Subjective Response for Overall Vision Quality assessed on a 0-100 scale (0- Unacceptable, 100- Excellent Vision) | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
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| Primary | Subjective Response for Overall Vision Quality | Subjective Response for Overall Vision Quality assessed on a 0-100 scale (0- Unacceptable, 100- Excellent Vision) | Posted | Mean | Standard Deviation | units on a scale | 2 weeks - Night Driving |
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| 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) | Posted | Count of Participants | Participants | Baseline - After 10 minutes of lens dispense |
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| 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) | Posted | Count of Participants | Participants | 2 Weeks |
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| Secondary | Subjective Preference for Comfort | Subjective preference for comfort (Orion strongly, Orion slightly, No preference, Gemini slightly, Gemini strongly) | Posted | Count of Participants | Participants | 2 weeks |
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| 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) | Posted | Mean | Standard Deviation | units on a scale | Baseline - After 10 minutes of lens dispense |
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| 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) | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
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| 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) | Posted | Mean | Standard Deviation | mm | Baseline - After 10 minutes of lens dispense |
|
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| 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) | Posted | Mean | Standard Deviation | mm | 2 weeks |
|
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| 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) | Posted | Mean | Standard Deviation | mm | Baseline - After 10 minutes of lens dispense |
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| 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) | Posted | Mean | Standard Deviation | mm | 2 weeks |
|
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| Secondary | Post-blink Movement | Post-blink movement assessed on the amount of lens movement to the nearest 0.1mm immediately after the blink | Posted | Mean | Standard Deviation | mm | Baseline - after 10 minutes of lens dispense |
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| Secondary | Post-blink Movement | Post-blink movement assessed on the amount of lens movement to the nearest 0.1mm immediately after the blink | Posted | Mean | Standard Deviation | mm | 2 weeks |
|
|
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| 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) | Posted | Mean | Standard Deviation | units on a scale | Baseline - after 10 minutes of lens dispense |
|
|
|
| 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) | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
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| 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). | Posted | Mean | Standard Deviation | units on a scale | Baseline - after 10 minutes of lens dispense |
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| 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). | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
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| 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) | Posted | Mean | Standard Deviation | units on a scale | Baseline - after 10 minutes of lens dispense |
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| 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) | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
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| 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) | Posted | Count of Participants | Participants | 2 weeks |
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| Secondary | Subjective Overall Lens Handling | SubjectiveOverall Lens handling assessed on a scale of 0-100 (0- cannot be managed, 100- Excellent handling) | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
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| 0 |
| 64 |
| 0 |
| 64 |
| 0 |
| 64 |
| EG001 | Gemini | Subjects were randomized to wear Gemini daily disposable contact lenses for 2 weeks in this randomized, cross-over bilateral dispensing study. Gemini daily disposable contact lens: | 0 | 64 | 0 | 64 | 0 | 64 |
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| Somewhat Satisfied |
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| Neither |
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| Somewhat Dissatisfied |
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| Dissatisfied |
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| Very Dissatisfied |
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| Somewhat Satisfied |
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| Neither |
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| Somewhat Dissatisfied |
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| Dissatisfied |
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| Very Dissatisfied |
|
| Somewhat satisfied |
|
| Neither |
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| Somewhat Dissatisfied |
|
| Dissatisfied |
|
| Very Dissatisfied |
|
| Somewhat satisfied |
|
| Neither |
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| Somewhat Dissatisfied |
|
| Dissatisfied |
|
| Very Dissatisfied |
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| Title | Measurements |
|---|
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| Gemini slightly |
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| Gemini strongly |
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| Temporal |
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| Superior |
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| Inferior |
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| Temporal |
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| Superior |
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| Inferior |
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| Somewhat satisfied |
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| Neither |
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| Somewhat Dissatisfied |
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| Dissatisfied |
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| Very Dissatisfied |
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