A Two-Week Crossover Dispensing Evaluation Of Orion Daily Wear Soft Contact Lens

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04585646
• Collaborator: (none)
• Enrollment: 64
• Location: 1
• Arms: 2
• Actual Duration (Months): 3.5
• Patients Per Site Per Month: 18

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: Orion daily disposable contact lens; Device: Gemini daily disposable contact lens	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 64 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Two-Week Crossover Dispensing Evaluation Of Orion Daily Wear Soft Contact Lens
• Actual Study Start Date: Sep 14, 2020
• Actual Primary Completion Date: Nov 30, 2020
• Actual Study Completion Date: Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Orion then Gemini 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.	Device: Orion daily disposable contact lens; Subjects will be randomized to wear Orion lens for 2 weeks.; Device: Gemini daily disposable contact lens; Subjects will be randomized to wear Gemini lens for 2 weeks.
Experimental: Gemini then Orion 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.	Device: Orion daily disposable contact lens; Subjects will be randomized to wear Orion lens for 2 weeks.; Device: Gemini daily disposable contact lens; Subjects will be randomized to wear Gemini lens for 2 weeks.

Outcome Measures

Primary Outcome Measures

1. 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)

2. 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)

3. Subjective Response for Overall Vision Satisfaction [2 Weeks - at night]

   Subjective Response for Vision satisfaction assessed on 7-point Likert (Very satisfied, Satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied)

4. 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)

5. Subjective Response for Overall Vision Quality [2 weeks]

   Subjective Response for Overall Vision Quality assessed on a 0-100 scale (0- Unacceptable, 100- Excellent Vision)

6. Subjective Response for Overall Vision Quality [2 weeks - Night Driving]

   Subjective Response for Overall Vision Quality assessed on a 0-100 scale (0- Unacceptable, 100- Excellent Vision)

Secondary Outcome Measures

1. 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)

2. Subjective Overall Comfort Satisfaction [2 Weeks]

   Overall comfort satisfaction analyzed on 7-point Likert (Very satisfied, Satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied)

3. Subjective Preference for Comfort [2 weeks]

   Subjective preference for comfort (Orion strongly, Orion slightly, No preference, Gemini slightly, Gemini strongly)

4. 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)

5. Lens Surface Wettability Performance [2 weeks]

   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)

6. 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)

7. Horizontal Lens Centration [2 weeks]

   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)

8. 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)

9. Vertical Lens Centration [2 weeks]

   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)

10. 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

11. Post-blink Movement [2 weeks]

    Post-blink movement assessed on the amount of lens movement to the nearest 0.1mm immediately after the blink

12. 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)

13. Lens Horizontal Mobility Rating [2 weeks]

    Lens Horizontal Mobility Rating on a scale of 0-4 (0-immobile, 1- restricted, 2- secure, 3- unrestricted, 4- very mobile)

14. 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).

15. Corneal Staining Extent [2 weeks]

    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).

16. 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)

17. Overall Lens Fit Acceptance [2 weeks]

    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)

18. 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)

19. Subjective Overall Lens Handling [2 weeks]

    SubjectiveOverall Lens handling assessed on a scale of 0-100 (0- cannot be managed, 100- Excellent handling)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CORL, Indiana University	Bloomington	Indiana	United States	47405

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

• Principal Investigator: Pete S Kollbaum, Indiana University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 20, 2020

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT04585646
• Other Study ID Numbers: CV-20-18
• First Posted: Oct 14, 2020
• Last Update Posted: May 10, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Arm/Group Title	Orion Then Gemini	Gemini Then Orion
Arm/Group Description	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.	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.
Period Title: First Intervention
STARTED	32	32
COMPLETED	31	28
NOT COMPLETED	1	4
Period Title: First Intervention
STARTED	31	28
COMPLETED	31	28
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Overall Study
Arm/Group Description	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
Overall Participants	64
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	64 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	23 (4)
Sex: Female, Male (Count of Participants)
Female	49 76.6%
Male	15 23.4%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	64 100%

Outcome Measures

1. Primary Outcome

Title	Subjective Response for Vision Satisfaction
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Orion	Gemini
Arm/Group Description	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	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:
Measure Participants	59	59
Very satisfied	24 37.5%	28 NaN
Satisfied	30 46.9%	24 NaN
Somewhat Satisfied	4 6.3%	7 NaN
Neither	1 1.6%	0 NaN
Somewhat Dissatisfied	0 0%	0 NaN
Dissatisfied	0 0%	0 NaN
Very Dissatisfied	0 0%	0 NaN

2. Primary Outcome

Title	Subjective Response for Overall Vision Satisfaction
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Orion	Gemini
Arm/Group Description	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	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:
Measure Participants	59	59
Very satisfied	26 40.6%	28 NaN
Satisfied	22 34.4%	24 NaN
Somewhat Satisfied	7 10.9%	5 NaN
Neither	0 0%	1 NaN
Somewhat Dissatisfied	3 4.7%	1 NaN
Dissatisfied	1 1.6%	0 NaN
Very Dissatisfied	0 0%	0 NaN

3. Primary Outcome

Title	Subjective Response for Overall Vision Satisfaction
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Orion	Gemini
Arm/Group Description	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	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:
Measure Participants	59	59
Very satisfied	42 65.6%	34 NaN
Satisfied	41 64.1%	48 NaN
Somewhat Satisfied	8 12.5%	10 NaN
Neither	7 10.9%	3 NaN
Somewhat Dissatisfied	2 3.1%	5 NaN
Dissatisfied	0 0%	0 NaN
Very Dissatisfied	0 0%	0 NaN

4. Primary Outcome

Title	Subjective Response for Overall Vision Quality
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Orion	Gemini
Arm/Group Description	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	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:
Measure Participants	59	59
Mean (Standard Deviation) [units on a scale]	90 (8)	91 (9)

5. Primary Outcome

Title	Subjective Response for Overall Vision Quality
Description	Subjective Response for Overall Vision Quality assessed on a 0-100 scale (0- Unacceptable, 100- Excellent Vision)
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Orion	Gemini
Arm/Group Description	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	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:
Measure Participants	59	59
Mean (Standard Deviation) [units on a scale]	86 (16)	89 (10)

6. Primary Outcome

Title	Subjective Response for Overall Vision Quality
Description	Subjective Response for Overall Vision Quality assessed on a 0-100 scale (0- Unacceptable, 100- Excellent Vision)
Time Frame	2 weeks - Night Driving

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Orion	Gemini
Arm/Group Description	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	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:
Measure Participants	59	59
Mean (Standard Deviation) [units on a scale]	87 (13)	88 (10)

7. Secondary Outcome

Title	Subjective Overall Comfort Satisfaction
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Orion	Gemini
Arm/Group Description	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	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:
Measure Participants	59	59
Very satisfied	32 50%	31 NaN
Satisfied	20 31.3%	22 NaN
Somewhat satisfied	7 10.9%	6 NaN
Neither	0 0%	0 NaN
Somewhat Dissatisfied	0 0%	0 NaN
Dissatisfied	0 0%	0 NaN
Very Dissatisfied	0 0%	0 NaN

8. Secondary Outcome

Title	Subjective Overall Comfort Satisfaction
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Orion	Gemini
Arm/Group Description	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	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:
Measure Participants	59	59
Very satisfied	22 34.4%	17 NaN
Satisfied	25 39.1%	19 NaN
Somewhat satisfied	6 9.4%	14 NaN
Neither	0 0%	2 NaN
Somewhat Dissatisfied	4 6.3%	4 NaN
Dissatisfied	2 3.1%	3 NaN
Very Dissatisfied	0 0%	0 NaN

9. Secondary Outcome

Title	Subjective Preference for Comfort
Description	Subjective preference for comfort (Orion strongly, Orion slightly, No preference, Gemini slightly, Gemini strongly)
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Overall Study
Arm/Group Description	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
Measure Participants	59
Orion strongly	13 20.3%
Orion slightly	21 32.8%
No preference	10 15.6%
Gemini slightly	7 10.9%
Gemini strongly	8 12.5%

10. Secondary Outcome

Title	Lens Surface Wettability Performance
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Orion	Gemini
Arm/Group Description	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	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:
Measure Participants	59	59
Mean (Standard Deviation) [units on a scale]	3.40 (0.36)	3.32 (0.40)

11. Secondary Outcome

Title	Lens Surface Wettability Performance
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Orion	Gemini
Arm/Group Description	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	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:
Measure Participants	59	59
Mean (Standard Deviation) [units on a scale]	3.31 (0.41)	3.40 (0.38)

12. Secondary Outcome

Title	Horizontal Lens Centration
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Orion	Gemini
Arm/Group Description	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	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:
Measure Participants	59	59
Mean (Standard Deviation) [mm]	-0.12 (0.25)	-0.18 (0.26)

13. Secondary Outcome

Title	Horizontal Lens Centration
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Orion	Gemini
Arm/Group Description	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	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:
Measure Participants	59	59
Mean (Standard Deviation) [mm]	-0.13 (0.27)	-0.17 (0.27)

14. Secondary Outcome

Title	Vertical Lens Centration
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Orion	Gemini
Arm/Group Description	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	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:
Measure Participants	59	59
Mean (Standard Deviation) [mm]	0.03 (27)	0.06 (0.29)

15. Secondary Outcome

Title	Vertical Lens Centration
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Orion	Gemini
Arm/Group Description	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	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:
Measure Participants	59	59
Mean (Standard Deviation) [mm]	0.09 (0.27)	0.12 (0.32)

16. Secondary Outcome

Title	Post-blink Movement
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Orion	Gemini
Arm/Group Description	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	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:
Measure Participants	59	59
Mean (Standard Deviation) [mm]	0.28 (0.08)	0.29 (0.09)

17. Secondary Outcome

Title	Post-blink Movement
Description	Post-blink movement assessed on the amount of lens movement to the nearest 0.1mm immediately after the blink
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Orion	Gemini
Arm/Group Description	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	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:
Measure Participants	59	59
Mean (Standard Deviation) [mm]	0.29 (0.08)	0.32 (0.09)

18. Secondary Outcome

Title	Lens Horizontal Mobility Rating
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Orion	Gemini
Arm/Group Description	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	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:
Measure Participants	59	59
Mean (Standard Deviation) [units on a scale]	2.36 (0.30)	2.33 (0.29)

19. Secondary Outcome

Title	Lens Horizontal Mobility Rating
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Orion	Gemini
Arm/Group Description	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	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:
Measure Participants	59	59
Mean (Standard Deviation) [units on a scale]	2.36 (0.28)	2.41 (0.31)

20. Secondary Outcome

Title	Corneal Staining Extent
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Orion	Gemini
Arm/Group Description	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	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:
Measure Participants	59	59
Central	0.00 (0.00)	0.00 (0.00)
Nasal	0.01 (0.09)	0.01 (0.09)
Temporal	000 (0.00)	0.00 (0.00)
Superior	0.00 (0.00)	0.00 (0.00)
Inferior	0.01 (0.09)	0.01 (0.09)

21. Secondary Outcome

Title	Corneal Staining Extent
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Orion	Gemini
Arm/Group Description	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	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:
Measure Participants	59	59
Central	0.00 (0.00)	0.00 (0.00)
Nasal	0.02 (0.13)	0.01 (0.09)
Temporal	0.00 (0.00)	0.00 (0.00)
Superior	0.00 (0.00)	0.00 (0.00)
Inferior	0.01 (0.38)	0.15 (0.39)

22. Secondary Outcome

Title	Overall Lens Fit Acceptance
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Orion	Gemini
Arm/Group Description	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	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:
Measure Participants	59	59
Mean (Standard Deviation) [units on a scale]	3.20 (0.32)	3.11 (0.32)

23. Secondary Outcome

Title	Overall Lens Fit Acceptance
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Orion	Gemini
Arm/Group Description	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	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:
Measure Participants	59	59
Mean (Standard Deviation) [units on a scale]	3.22 (0.34)	3.11 (0.39)

24. Secondary Outcome

Title	Lens Handling Satisfaction
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Orion	Gemini
Arm/Group Description	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	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:
Measure Participants	59	59
Very satisfied	27 42.2%	14 NaN
satisfied	20 31.3%	27 NaN
Somewhat satisfied	8 12.5%	11 NaN
Neither	2 3.1%	3 NaN
Somewhat Dissatisfied	1 1.6%	3 NaN
Dissatisfied	1 1.6%	1 NaN
Very Dissatisfied	0 0%	0 NaN

25. Secondary Outcome

Title	Subjective Overall Lens Handling
Description	SubjectiveOverall Lens handling assessed on a scale of 0-100 (0- cannot be managed, 100- Excellent handling)
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Orion	Gemini
Arm/Group Description	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	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:
Measure Participants	59	59
Mean (Standard Deviation) [units on a scale]	87 (14)	83 (16)

Adverse Events

Time Frame	From dispense up to 2 weeks on each study lens, a total of 4 weeks,
Arm/Group Title	Orion		Gemini
Arm/Group Description	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		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:
All Cause Mortality
	Orion		Gemini
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/64 (0%)		0/64 (0%)
Serious Adverse Events
	Orion		Gemini
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/64 (0%)		0/64 (0%)
Other (Not Including Serious) Adverse Events
	Orion		Gemini
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/64 (0%)		0/64 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.