Trial Outcomes & Findings for A Two-Week Crossover Dispensing Evaluation Of Orion Daily Wear Soft Contact Lens (NCT NCT04585646)
NCT ID: NCT04585646
Last Updated: 2022-05-10
Results Overview
Subjective Response for Vision Satisfaction assessed on 7-point Likert (Very satisfied, Satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
64 participants
Primary outcome timeframe
Baseline - After 10 minutes of lens dispense
Results posted on
2022-05-10
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
First Intervention
STARTED
|
32
|
32
|
|
First Intervention
COMPLETED
|
31
|
28
|
|
First Intervention
NOT COMPLETED
|
1
|
4
|
|
Second Intervention
STARTED
|
31
|
28
|
|
Second Intervention
COMPLETED
|
31
|
28
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
First Intervention
Physician Decision
|
1
|
0
|
|
First Intervention
Lost to Follow-up
|
0
|
3
|
|
First Intervention
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Overall Study
n=64 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=64 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
64 Participants
n=64 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=64 Participants
|
|
Age, Continuous
|
23 years
STANDARD_DEVIATION 4 • n=64 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=64 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=64 Participants
|
|
Region of Enrollment
United States
|
64 participants
n=64 Participants
|
PRIMARY outcome
Timeframe: Baseline - After 10 minutes of lens dispenseSubjective Response for Vision Satisfaction assessed on 7-point Likert (Very satisfied, Satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied)
Outcome measures
| Measure |
Orion
n=59 Participants
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
|
Gemini
n=59 Participants
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:
|
|---|---|---|
|
Subjective Response for Vision Satisfaction
Very satisfied
|
24 Participants
|
28 Participants
|
|
Subjective Response for Vision Satisfaction
Satisfied
|
30 Participants
|
24 Participants
|
|
Subjective Response for Vision Satisfaction
Somewhat Satisfied
|
4 Participants
|
7 Participants
|
|
Subjective Response for Vision Satisfaction
Neither
|
1 Participants
|
0 Participants
|
|
Subjective Response for Vision Satisfaction
Somewhat Dissatisfied
|
0 Participants
|
0 Participants
|
|
Subjective Response for Vision Satisfaction
Dissatisfied
|
0 Participants
|
0 Participants
|
|
Subjective Response for Vision Satisfaction
Very Dissatisfied
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 2 WeeksSubjective Response for Vision satisfaction assessed on 7-point Likert (Very satisfied, Satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied)
Outcome measures
| Measure |
Orion
n=59 Participants
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
|
Gemini
n=59 Participants
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:
|
|---|---|---|
|
Subjective Response for Overall Vision Satisfaction
Very satisfied
|
26 Participants
|
28 Participants
|
|
Subjective Response for Overall Vision Satisfaction
Satisfied
|
22 Participants
|
24 Participants
|
|
Subjective Response for Overall Vision Satisfaction
Somewhat Satisfied
|
7 Participants
|
5 Participants
|
|
Subjective Response for Overall Vision Satisfaction
Neither
|
0 Participants
|
1 Participants
|
|
Subjective Response for Overall Vision Satisfaction
Somewhat Dissatisfied
|
3 Participants
|
1 Participants
|
|
Subjective Response for Overall Vision Satisfaction
Dissatisfied
|
1 Participants
|
0 Participants
|
|
Subjective Response for Overall Vision Satisfaction
Very Dissatisfied
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 2 Weeks - at nightSubjective Response for Vision satisfaction assessed on 7-point Likert (Very satisfied, Satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied)
Outcome measures
| Measure |
Orion
n=59 Participants
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
|
Gemini
n=59 Participants
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:
|
|---|---|---|
|
Subjective Response for Overall Vision Satisfaction
Very satisfied
|
42 percentage of participants
|
34 percentage of participants
|
|
Subjective Response for Overall Vision Satisfaction
Satisfied
|
41 percentage of participants
|
48 percentage of participants
|
|
Subjective Response for Overall Vision Satisfaction
Somewhat Satisfied
|
8 percentage of participants
|
10 percentage of participants
|
|
Subjective Response for Overall Vision Satisfaction
Neither
|
7 percentage of participants
|
3 percentage of participants
|
|
Subjective Response for Overall Vision Satisfaction
Somewhat Dissatisfied
|
2 percentage of participants
|
5 percentage of participants
|
|
Subjective Response for Overall Vision Satisfaction
Dissatisfied
|
0 percentage of participants
|
0 percentage of participants
|
|
Subjective Response for Overall Vision Satisfaction
Very Dissatisfied
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline - After 10 minutes of lens dispenseSubjective Response for Overall Vision quality assessed on a 0-100 scale (0- Unacceptable, 100- Excellent Vision)
Outcome measures
| Measure |
Orion
n=59 Participants
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
|
Gemini
n=59 Participants
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:
|
|---|---|---|
|
Subjective Response for Overall Vision Quality
|
90 units on a scale
Standard Deviation 8
|
91 units on a scale
Standard Deviation 9
|
PRIMARY outcome
Timeframe: 2 weeksSubjective Response for Overall Vision Quality assessed on a 0-100 scale (0- Unacceptable, 100- Excellent Vision)
Outcome measures
| Measure |
Orion
n=59 Participants
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
|
Gemini
n=59 Participants
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:
|
|---|---|---|
|
Subjective Response for Overall Vision Quality
|
86 units on a scale
Standard Deviation 16
|
89 units on a scale
Standard Deviation 10
|
PRIMARY outcome
Timeframe: 2 weeks - Night DrivingSubjective Response for Overall Vision Quality assessed on a 0-100 scale (0- Unacceptable, 100- Excellent Vision)
Outcome measures
| Measure |
Orion
n=59 Participants
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
|
Gemini
n=59 Participants
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:
|
|---|---|---|
|
Subjective Response for Overall Vision Quality
|
87 units on a scale
Standard Deviation 13
|
88 units on a scale
Standard Deviation 10
|
SECONDARY outcome
Timeframe: Baseline - After 10 minutes of lens dispenseOverall comfort satisfaction analyzed on 7-point Likert (Very satisfied, Satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied)
Outcome measures
| Measure |
Orion
n=59 Participants
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
|
Gemini
n=59 Participants
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:
|
|---|---|---|
|
Subjective Overall Comfort Satisfaction
Very satisfied
|
32 Participants
|
31 Participants
|
|
Subjective Overall Comfort Satisfaction
Satisfied
|
20 Participants
|
22 Participants
|
|
Subjective Overall Comfort Satisfaction
Somewhat satisfied
|
7 Participants
|
6 Participants
|
|
Subjective Overall Comfort Satisfaction
Neither
|
0 Participants
|
0 Participants
|
|
Subjective Overall Comfort Satisfaction
Somewhat Dissatisfied
|
0 Participants
|
0 Participants
|
|
Subjective Overall Comfort Satisfaction
Dissatisfied
|
0 Participants
|
0 Participants
|
|
Subjective Overall Comfort Satisfaction
Very Dissatisfied
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 WeeksOverall comfort satisfaction analyzed on 7-point Likert (Very satisfied, Satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied)
Outcome measures
| Measure |
Orion
n=59 Participants
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
|
Gemini
n=59 Participants
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:
|
|---|---|---|
|
Subjective Overall Comfort Satisfaction
Very satisfied
|
22 Participants
|
17 Participants
|
|
Subjective Overall Comfort Satisfaction
Satisfied
|
25 Participants
|
19 Participants
|
|
Subjective Overall Comfort Satisfaction
Somewhat satisfied
|
6 Participants
|
14 Participants
|
|
Subjective Overall Comfort Satisfaction
Neither
|
0 Participants
|
2 Participants
|
|
Subjective Overall Comfort Satisfaction
Somewhat Dissatisfied
|
4 Participants
|
4 Participants
|
|
Subjective Overall Comfort Satisfaction
Dissatisfied
|
2 Participants
|
3 Participants
|
|
Subjective Overall Comfort Satisfaction
Very Dissatisfied
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 weeksSubjective preference for comfort (Orion strongly, Orion slightly, No preference, Gemini slightly, Gemini strongly)
Outcome measures
| Measure |
Orion
n=59 Participants
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
|
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:
|
|---|---|---|
|
Subjective Preference for Comfort
Orion strongly
|
13 Participants
|
—
|
|
Subjective Preference for Comfort
Orion slightly
|
21 Participants
|
—
|
|
Subjective Preference for Comfort
No preference
|
10 Participants
|
—
|
|
Subjective Preference for Comfort
Gemini slightly
|
7 Participants
|
—
|
|
Subjective Preference for Comfort
Gemini strongly
|
8 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline - After 10 minutes of lens dispenseLens 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)
Outcome measures
| Measure |
Orion
n=59 Participants
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
|
Gemini
n=59 Participants
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:
|
|---|---|---|
|
Lens Surface Wettability Performance
|
3.40 units on a scale
Standard Deviation 0.36
|
3.32 units on a scale
Standard Deviation 0.40
|
SECONDARY outcome
Timeframe: 2 weeksLens 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)
Outcome measures
| Measure |
Orion
n=59 Participants
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
|
Gemini
n=59 Participants
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:
|
|---|---|---|
|
Lens Surface Wettability Performance
|
3.31 units on a scale
Standard Deviation 0.41
|
3.40 units on a scale
Standard Deviation 0.38
|
SECONDARY outcome
Timeframe: Baseline - After 10 minutes of lens dispenseHorizontal 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)
Outcome measures
| Measure |
Orion
n=59 Participants
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
|
Gemini
n=59 Participants
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:
|
|---|---|---|
|
Horizontal Lens Centration
|
-0.12 mm
Standard Deviation 0.25
|
-0.18 mm
Standard Deviation 0.26
|
SECONDARY outcome
Timeframe: 2 weeksHorizontal 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)
Outcome measures
| Measure |
Orion
n=59 Participants
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
|
Gemini
n=59 Participants
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:
|
|---|---|---|
|
Horizontal Lens Centration
|
-0.13 mm
Standard Deviation 0.27
|
-0.17 mm
Standard Deviation 0.27
|
SECONDARY outcome
Timeframe: Baseline - After 10 minutes of lens dispenseVertical 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)
Outcome measures
| Measure |
Orion
n=59 Participants
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
|
Gemini
n=59 Participants
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:
|
|---|---|---|
|
Vertical Lens Centration
|
0.03 mm
Standard Deviation 27
|
0.06 mm
Standard Deviation 0.29
|
SECONDARY outcome
Timeframe: 2 weeksVertical 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)
Outcome measures
| Measure |
Orion
n=59 Participants
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
|
Gemini
n=59 Participants
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:
|
|---|---|---|
|
Vertical Lens Centration
|
0.09 mm
Standard Deviation 0.27
|
0.12 mm
Standard Deviation 0.32
|
SECONDARY outcome
Timeframe: Baseline - after 10 minutes of lens dispensePost-blink movement assessed on the amount of lens movement to the nearest 0.1mm immediately after the blink
Outcome measures
| Measure |
Orion
n=59 Participants
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
|
Gemini
n=59 Participants
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:
|
|---|---|---|
|
Post-blink Movement
|
0.28 mm
Standard Deviation 0.08
|
0.29 mm
Standard Deviation 0.09
|
SECONDARY outcome
Timeframe: 2 weeksPost-blink movement assessed on the amount of lens movement to the nearest 0.1mm immediately after the blink
Outcome measures
| Measure |
Orion
n=59 Participants
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
|
Gemini
n=59 Participants
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:
|
|---|---|---|
|
Post-blink Movement
|
0.29 mm
Standard Deviation 0.08
|
0.32 mm
Standard Deviation 0.09
|
SECONDARY outcome
Timeframe: Baseline - after 10 minutes of lens dispenseLens Horizontal Mobility Rating on a scale of 0-4 (0-immobile, 1- restricted, 2- secure, 3- unrestricted, 4- very mobile)
Outcome measures
| Measure |
Orion
n=59 Participants
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
|
Gemini
n=59 Participants
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:
|
|---|---|---|
|
Lens Horizontal Mobility Rating
|
2.36 units on a scale
Standard Deviation 0.30
|
2.33 units on a scale
Standard Deviation 0.29
|
SECONDARY outcome
Timeframe: 2 weeksLens Horizontal Mobility Rating on a scale of 0-4 (0-immobile, 1- restricted, 2- secure, 3- unrestricted, 4- very mobile)
Outcome measures
| Measure |
Orion
n=59 Participants
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
|
Gemini
n=59 Participants
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:
|
|---|---|---|
|
Lens Horizontal Mobility Rating
|
2.36 units on a scale
Standard Deviation 0.28
|
2.41 units on a scale
Standard Deviation 0.31
|
SECONDARY outcome
Timeframe: Baseline - after 10 minutes of lens dispenseCorneal 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).
Outcome measures
| Measure |
Orion
n=59 Participants
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
|
Gemini
n=59 Participants
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:
|
|---|---|---|
|
Corneal Staining Extent
Central
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Corneal Staining Extent
Nasal
|
0.01 units on a scale
Standard Deviation 0.09
|
0.01 units on a scale
Standard Deviation 0.09
|
|
Corneal Staining Extent
Temporal
|
000 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Corneal Staining Extent
Superior
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Corneal Staining Extent
Inferior
|
0.01 units on a scale
Standard Deviation 0.09
|
0.01 units on a scale
Standard Deviation 0.09
|
SECONDARY outcome
Timeframe: 2 weeksCorneal 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).
Outcome measures
| Measure |
Orion
n=59 Participants
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
|
Gemini
n=59 Participants
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:
|
|---|---|---|
|
Corneal Staining Extent
Central
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Corneal Staining Extent
Nasal
|
0.02 units on a scale
Standard Deviation 0.13
|
0.01 units on a scale
Standard Deviation 0.09
|
|
Corneal Staining Extent
Temporal
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Corneal Staining Extent
Superior
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Corneal Staining Extent
Inferior
|
0.01 units on a scale
Standard Deviation 0.38
|
0.15 units on a scale
Standard Deviation 0.39
|
SECONDARY outcome
Timeframe: Baseline - after 10 minutes of lens dispenseOverall 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)
Outcome measures
| Measure |
Orion
n=59 Participants
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
|
Gemini
n=59 Participants
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:
|
|---|---|---|
|
Overall Lens Fit Acceptance
|
3.20 units on a scale
Standard Deviation 0.32
|
3.11 units on a scale
Standard Deviation 0.32
|
SECONDARY outcome
Timeframe: 2 weeksOverall 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)
Outcome measures
| Measure |
Orion
n=59 Participants
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
|
Gemini
n=59 Participants
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:
|
|---|---|---|
|
Overall Lens Fit Acceptance
|
3.22 units on a scale
Standard Deviation 0.34
|
3.11 units on a scale
Standard Deviation 0.39
|
SECONDARY outcome
Timeframe: 2 weeksLens handling satisfaction assessed on a 7-point Likert Scales (Very satisfied, satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied)
Outcome measures
| Measure |
Orion
n=59 Participants
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
|
Gemini
n=59 Participants
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:
|
|---|---|---|
|
Lens Handling Satisfaction
Very satisfied
|
27 Participants
|
14 Participants
|
|
Lens Handling Satisfaction
satisfied
|
20 Participants
|
27 Participants
|
|
Lens Handling Satisfaction
Somewhat satisfied
|
8 Participants
|
11 Participants
|
|
Lens Handling Satisfaction
Neither
|
2 Participants
|
3 Participants
|
|
Lens Handling Satisfaction
Somewhat Dissatisfied
|
1 Participants
|
3 Participants
|
|
Lens Handling Satisfaction
Dissatisfied
|
1 Participants
|
1 Participants
|
|
Lens Handling Satisfaction
Very Dissatisfied
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 weeksSubjectiveOverall Lens handling assessed on a scale of 0-100 (0- cannot be managed, 100- Excellent handling)
Outcome measures
| Measure |
Orion
n=59 Participants
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
|
Gemini
n=59 Participants
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:
|
|---|---|---|
|
Subjective Overall Lens Handling
|
87 units on a scale
Standard Deviation 14
|
83 units on a scale
Standard Deviation 16
|
Adverse Events
Orion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Gemini
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place