Trial Outcomes & Findings for The Safety and Effectiveness of Breath-O Lenses (NCT NCT03616600)
NCT ID: NCT03616600
Last Updated: 2021-02-10
Results Overview
measured by ocular response analyser
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
31 participants
Primary outcome timeframe
Baseline, 1st Month, 3rd Month
Results posted on
2021-02-10
Participant Flow
Participant milestones
| Measure |
Treatment
Wearing the orthokeratology lenses for 3 months
Breath-O-Correct Lens: Breath-O correct lenses are new designed ready-made orthokeratology lenses which are made of new material with more elasticity as compared traditional lens material
|
Control
Not wearing any contact lenses
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Treatment
Wearing the orthokeratology lenses for 3 months
Breath-O-Correct Lens: Breath-O correct lenses are new designed ready-made orthokeratology lenses which are made of new material with more elasticity as compared traditional lens material
|
Control
Not wearing any contact lenses
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Treatment
n=15 Participants
Wearing the orthokeratology lenses for 3 months
Breath-O-Correct Lens: Breath-O correct lenses are new designed ready-made orthokeratology lenses which are made of new material with more elasticity as compared traditional lens material
|
Control
n=15 Participants
Not wearing any contact lenses
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=15 Participants
|
15 Participants
n=15 Participants
|
30 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=30 Participants
|
|
Age, Continuous
|
19.8 years
STANDARD_DEVIATION 0.7 • n=15 Participants
|
22.2 years
STANDARD_DEVIATION 2.4 • n=15 Participants
|
21.1 years
STANDARD_DEVIATION 2.1 • n=30 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=15 Participants
|
9 Participants
n=15 Participants
|
20 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=15 Participants
|
6 Participants
n=15 Participants
|
10 Participants
n=30 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Hong Kong
|
15 participants
n=15 Participants
|
15 participants
n=15 Participants
|
30 participants
n=30 Participants
|
|
Refractive errors
|
-3.47 Diopters
STANDARD_DEVIATION 1.01 • n=15 Participants
|
-3.71 Diopters
STANDARD_DEVIATION 1.76 • n=15 Participants
|
-3.61 Diopters
STANDARD_DEVIATION 1.40 • n=30 Participants
|
PRIMARY outcome
Timeframe: Baseline, 1st Month, 3rd Monthmeasured by ocular response analyser
Outcome measures
| Measure |
Treatment
n=15 Participants
Group randomly selected to wear the Breath-O Correct lenses
Breath-O-Correct Lens: Breath-O correct lenses are new designed ready-made orthokeratology lenses which are made of new material with more elasticity as compared traditional lens material
|
Control
n=15 Participants
Group randomly selected not to wear any contact lenses
|
|---|---|---|
|
Corneal Biomechanics in Terms of Corneal Hysteresis and Resistance Factor
Corneal Hysteresis_Baseline
|
11.12 mmHg
Standard Deviation 1.12
|
11.10 mmHg
Standard Deviation 1.36
|
|
Corneal Biomechanics in Terms of Corneal Hysteresis and Resistance Factor
Corneal Hysteresis_1st Month
|
10.37 mmHg
Standard Deviation 1.36
|
11.20 mmHg
Standard Deviation 1.89
|
|
Corneal Biomechanics in Terms of Corneal Hysteresis and Resistance Factor
Corneal Hysteresis_3rd Month
|
10.14 mmHg
Standard Deviation 0.89
|
11.19 mmHg
Standard Deviation 1.66
|
|
Corneal Biomechanics in Terms of Corneal Hysteresis and Resistance Factor
Corneal Resistance Factor_Baseline
|
11.07 mmHg
Standard Deviation 1.32
|
11.14 mmHg
Standard Deviation 2.23
|
|
Corneal Biomechanics in Terms of Corneal Hysteresis and Resistance Factor
Corneal Resistance Factor_1st Month
|
9.87 mmHg
Standard Deviation 1.45
|
10.92 mmHg
Standard Deviation 2.45
|
|
Corneal Biomechanics in Terms of Corneal Hysteresis and Resistance Factor
Corneal Resistance Factor_3rd Month
|
9.99 mmHg
Standard Deviation 1.37
|
10.79 mmHg
Standard Deviation 2.17
|
PRIMARY outcome
Timeframe: Baseline, 1st Month, 3rd Monthmeasured by specular microscope
Outcome measures
| Measure |
Treatment
n=15 Participants
Group randomly selected to wear the Breath-O Correct lenses
Breath-O-Correct Lens: Breath-O correct lenses are new designed ready-made orthokeratology lenses which are made of new material with more elasticity as compared traditional lens material
|
Control
n=15 Participants
Group randomly selected not to wear any contact lenses
|
|---|---|---|
|
Corneal Endothelial Health in Terms of Endothelial Cell Density
Corneal Endothelial Cell Density_Baseline
|
2909 cell/mm^2
Standard Deviation 145.1
|
2861 cell/mm^2
Standard Deviation 181.05
|
|
Corneal Endothelial Health in Terms of Endothelial Cell Density
Corneal Endothelial Cell Density_1st month
|
2923 cell/mm^2
Standard Deviation 123.01
|
2818 cell/mm^2
Standard Deviation 182.65
|
|
Corneal Endothelial Health in Terms of Endothelial Cell Density
Corneal Endothelial Cell Density_3rd month
|
2917 cell/mm^2
Standard Deviation 157.34
|
2825 cell/mm^2
Standard Deviation 177.80
|
PRIMARY outcome
Timeframe: Baseline, 1st Month, 3rd Monthmeasured by specular microscope
Outcome measures
| Measure |
Treatment
n=15 Participants
Group randomly selected to wear the Breath-O Correct lenses
Breath-O-Correct Lens: Breath-O correct lenses are new designed ready-made orthokeratology lenses which are made of new material with more elasticity as compared traditional lens material
|
Control
n=15 Participants
Group randomly selected not to wear any contact lenses
|
|---|---|---|
|
Corneal Endothelial Health in Terms of Percentage of Variation in Cell Size
Corneal Endothelial Cell Variance_Baseline
|
28.68 percentage
Standard Deviation 3.78
|
29.35 percentage
Standard Deviation 3.66
|
|
Corneal Endothelial Health in Terms of Percentage of Variation in Cell Size
Corneal Endothelial Cell Variance_1st month
|
28.47 percentage
Standard Deviation 3.51
|
29.00 percentage
Standard Deviation 3.58
|
|
Corneal Endothelial Health in Terms of Percentage of Variation in Cell Size
Corneal Endothelial Cell Variance_3rd month
|
29.00 percentage
Standard Deviation 6.53
|
30.01 percentage
Standard Deviation 3.32
|
PRIMARY outcome
Timeframe: Baseline, 1st Month, 3rd Monthmeasured by OCULUS Keratograph® 5M and graded by JENVIS redness grading system It is a scale of 0 to 4, the higher the score, the more redness the ocular surface manifests
Outcome measures
| Measure |
Treatment
n=15 Participants
Group randomly selected to wear the Breath-O Correct lenses
Breath-O-Correct Lens: Breath-O correct lenses are new designed ready-made orthokeratology lenses which are made of new material with more elasticity as compared traditional lens material
|
Control
n=15 Participants
Group randomly selected not to wear any contact lenses
|
|---|---|---|
|
Anterior Ocular Health in Terms of Limbal and Bulbar Redness
Bulbar redness_Baseline
|
0.57 units on a scale
Standard Deviation 0.18
|
0.58 units on a scale
Standard Deviation 0.28
|
|
Anterior Ocular Health in Terms of Limbal and Bulbar Redness
Bulbar redness_1st Month
|
0.47 units on a scale
Standard Deviation 0.19
|
0.52 units on a scale
Standard Deviation 0.21
|
|
Anterior Ocular Health in Terms of Limbal and Bulbar Redness
Bulbar redness_3rd Month
|
0.54 units on a scale
Standard Deviation 0.31
|
0.61 units on a scale
Standard Deviation 0.27
|
|
Anterior Ocular Health in Terms of Limbal and Bulbar Redness
Limbal redness_Baseline
|
0.26 units on a scale
Standard Deviation 0.19
|
0.29 units on a scale
Standard Deviation 0.26
|
|
Anterior Ocular Health in Terms of Limbal and Bulbar Redness
Limbal redness_1st Month
|
0.23 units on a scale
Standard Deviation 0.15
|
0.31 units on a scale
Standard Deviation 0.21
|
|
Anterior Ocular Health in Terms of Limbal and Bulbar Redness
Limbal redness_3rd Month
|
0.27 units on a scale
Standard Deviation 0.21
|
0.38 units on a scale
Standard Deviation 0.28
|
PRIMARY outcome
Timeframe: Baseline, 1st Month, 3rd Monthmeasured by OCULUS Keratograph® 5M
Outcome measures
| Measure |
Treatment
n=15 Participants
Group randomly selected to wear the Breath-O Correct lenses
Breath-O-Correct Lens: Breath-O correct lenses are new designed ready-made orthokeratology lenses which are made of new material with more elasticity as compared traditional lens material
|
Control
n=15 Participants
Group randomly selected not to wear any contact lenses
|
|---|---|---|
|
Anterior Ocular Surface Evaluation in Terms of Non-invasive Keratography Break-up Time (NIKBUT)
NIKBUT_1st break_Baseline
|
6.72 Second
Standard Deviation 3.96
|
9.92 Second
Standard Deviation 6.76
|
|
Anterior Ocular Surface Evaluation in Terms of Non-invasive Keratography Break-up Time (NIKBUT)
NIKBUT_1st break_1st Month
|
9.13 Second
Standard Deviation 5.45
|
9.17 Second
Standard Deviation 5.63
|
|
Anterior Ocular Surface Evaluation in Terms of Non-invasive Keratography Break-up Time (NIKBUT)
NIKBUT_1st break_3rd Month
|
9.83 Second
Standard Deviation 6.37
|
7.64 Second
Standard Deviation 4.97
|
|
Anterior Ocular Surface Evaluation in Terms of Non-invasive Keratography Break-up Time (NIKBUT)
NIKBUT_average_Baseline
|
10.94 Second
Standard Deviation 4.15
|
13.24 Second
Standard Deviation 6.56
|
|
Anterior Ocular Surface Evaluation in Terms of Non-invasive Keratography Break-up Time (NIKBUT)
NIKBUT_average_1st Month
|
12.42 Second
Standard Deviation 5.73
|
11.86 Second
Standard Deviation 5.99
|
|
Anterior Ocular Surface Evaluation in Terms of Non-invasive Keratography Break-up Time (NIKBUT)
NIKBUT_average_3rd Month
|
12.07 Second
Standard Deviation 6.76
|
9.57 Second
Standard Deviation 5.02
|
SECONDARY outcome
Timeframe: Baseline, 1st Month and the 3rd MonthPopulation: It is a comparison of visual performance before-and-after treatment and therefore only the best corrected visual acuity in treatment group in different time points were compared.
The best corrected visual acuity was measured in LogMAR (Snellen 20/20 vision = 0.00 in LogMAR ; each readable letter add -0.02 to the score, the smaller the number i.e. more negative, the better visual acuity)
Outcome measures
| Measure |
Treatment
n=15 Participants
Group randomly selected to wear the Breath-O Correct lenses
Breath-O-Correct Lens: Breath-O correct lenses are new designed ready-made orthokeratology lenses which are made of new material with more elasticity as compared traditional lens material
|
Control
Group randomly selected not to wear any contact lenses
|
|---|---|---|
|
Best Corrected Visual Acuity in Terms of High and Low Contrast
High contrast VA_Baseline
|
-0.10 LogMAR
Standard Deviation 0.06
|
—
|
|
Best Corrected Visual Acuity in Terms of High and Low Contrast
High contrast VA_1st Month
|
-0.07 LogMAR
Standard Deviation 0.08
|
—
|
|
Best Corrected Visual Acuity in Terms of High and Low Contrast
High contrast VA_3rd Month
|
-0.08 LogMAR
Standard Deviation 0.08
|
—
|
|
Best Corrected Visual Acuity in Terms of High and Low Contrast
Low contrast VA_Basline
|
0.08 LogMAR
Standard Deviation 0.08
|
—
|
|
Best Corrected Visual Acuity in Terms of High and Low Contrast
Low contrast VA_1st Month
|
0.22 LogMAR
Standard Deviation 0.14
|
—
|
|
Best Corrected Visual Acuity in Terms of High and Low Contrast
Low contrast VA_3rd Month
|
0.17 LogMAR
Standard Deviation 0.13
|
—
|
SECONDARY outcome
Timeframe: Baseline, 1st Week, 1st Month, 3rd MonthPopulation: It is a comparison of refractive errors before-and-after treatment and therefore only the refractive errors in treatment group in different time points were compared.
Refractive errors were determined by subjective refraction for treatment group (Breath-O correct lens wearer), the outcome was represented as mean spherical equivalent refraction with unit in diopter (SER, = 1/2 Cylindrical power + spherical power)
Outcome measures
| Measure |
Treatment
n=15 Participants
Group randomly selected to wear the Breath-O Correct lenses
Breath-O-Correct Lens: Breath-O correct lenses are new designed ready-made orthokeratology lenses which are made of new material with more elasticity as compared traditional lens material
|
Control
Group randomly selected not to wear any contact lenses
|
|---|---|---|
|
Reduction of the Refractive Power After Wearing the Breath-O-correct Lens
Refractive errors_Baseline
|
-3.52 Diopter
Standard Deviation 1.02
|
—
|
|
Reduction of the Refractive Power After Wearing the Breath-O-correct Lens
Refractive errors_1st Week
|
-0.17 Diopter
Standard Deviation 0.99
|
—
|
|
Reduction of the Refractive Power After Wearing the Breath-O-correct Lens
Refractive errors_1st Month
|
-0.11 Diopter
Standard Deviation 0.92
|
—
|
|
Reduction of the Refractive Power After Wearing the Breath-O-correct Lens
Refractive errors_3rd Month
|
-0.03 Diopter
Standard Deviation 0.82
|
—
|
Adverse Events
Treatment
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment
n=16 participants at risk
Wearing the orthokeratology lenses for 3 months
Breath-O-Correct Lens: Breath-O correct lenses are new designed ready-made orthokeratology lenses which are made of new material with more elasticity as compared traditional lens material
|
Control
n=15 participants at risk
Not wearing any contact lenses
|
|---|---|---|
|
Eye disorders
poor visual quality
|
6.2%
1/16 • 3 months
|
0.00%
0/15 • 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place