The Safety and Effectiveness of Breath-O Lenses

• Sponsor: The Hong Kong Polytechnic University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03616600
• Collaborator: SEED Co. Ltd. (Other)
• Enrollment: 31
• Location: 1
• Arms: 2
• Actual Duration (Months): 10.5
• Patients Per Site Per Month: 2.9

Study Details

Study Description

Brief Summary

In Hong Kong, approximately 80% of children are myopic by the end of childhood. There is intense interest currently in the potential role of peripheral defocus as a clinical treatment to slow myopia progression. One of the most successful treatments for myopia is orthokeratology. Currently, Breath-O correct lenses are new designed ready-made orthokeratology lenses. This study is to evaluate the safety of wearing this new orthokeratology lens and the effectiveness of clinical performance in young adult.

Condition or Disease	Intervention/Treatment	Phase
Myopia; Safety Issues	Other: Breath-O-Correct Lens	N/A

Detailed Description

Short-sightedness (myopia) is the most common refractive error in the world. In Hong Kong, approximately 80% of children are myopic by the end of childhood. Current treatment strategies to control (i.e. slow) myopia progression in children are primarily designed to harness the natural "emmetropization" process, in which visual feedback from retinal image clarity regulates the rate of eye growth. There is intense interest currently in the potential role of peripheral defocus as a clinical treatment to slow myopia progression, not least since this approach permits clear central vision. One of the most successful treatments for myopia is orthokeratology, which is a therapy of using custom-made rigid gas permeable contact lens. The special design of this contact lens can reshape the corneal profile to minimize the central refractive error while producing beneficial peripheral defocus. Currently, 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. This study is to evaluate the safety of wearing this new orthokeratology lens and the effectiveness of clinical performance in young adult.

Study Design

• Study Type: Interventional
• Actual Enrollment: 31 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized control trialRandomized control trial
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Safety and Effectiveness of Clinical Performance of Breath-O Correct Orthokeratology Lenses
• Actual Study Start Date: Mar 1, 2018
• Actual Primary Completion Date: Aug 31, 2018
• Actual Study Completion Date: Jan 15, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Wearing the orthokeratology lenses for 3 months	Other: 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
No Intervention: Control Not wearing any contact lenses

Outcome Measures

Primary Outcome Measures

1. Corneal Biomechanics in Terms of Corneal Hysteresis and Resistance Factor [Baseline, 1st Month, 3rd Month]

   measured by ocular response analyser

2. Corneal Endothelial Health in Terms of Endothelial Cell Density [Baseline, 1st Month, 3rd Month]

   measured by specular microscope

3. Corneal Endothelial Health in Terms of Percentage of Variation in Cell Size [Baseline, 1st Month, 3rd Month]

   measured by specular microscope

4. Anterior Ocular Health in Terms of Limbal and Bulbar Redness [Baseline, 1st Month, 3rd Month]

   measured 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

5. Anterior Ocular Surface Evaluation in Terms of Non-invasive Keratography Break-up Time (NIKBUT) [Baseline, 1st Month, 3rd Month]

   measured by OCULUS Keratograph® 5M

Secondary Outcome Measures

1. Best Corrected Visual Acuity in Terms of High and Low Contrast [Baseline, 1st Month and the 3rd Month]

   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)

2. Reduction of the Refractive Power After Wearing the Breath-O-correct Lens [Baseline, 1st Week, 1st Month, 3rd Month]

   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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 30 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Refractive error: Spherical: normally -1.00D to -4.00D (maximum up to -5.00D); Cylindrical: normally half of Sph (against-the-rule Astigmatism.: lower than -0.75D) (maximum up to -1.50D)

2. Best corrected Visual acuity: monocular ETDRS 0.0 or better

3. Ocular health: No ocular abnormality, no contra-indications for overnight orthokeratology lens wear, no refractive surgery

4. General health: No systemic diseases

5. Requirement: No history of orthokeratology lens wearing. Agree to participate in this study and willing to wear the orthokeratology lenses overnight in accordance with the instructions given and to come back for follow up within the study period

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Hong Kong Polytechnic University	Hong Kong		Hong Kong

Sponsors and Collaborators

• The Hong Kong Polytechnic University
• SEED Co. Ltd.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 10, 2019

More Information

Publications

None provided.

• Responsible Party: Henry HL Chan, PhD, Assocaite Professor, The Hong Kong Polytechnic University
• ClinicalTrials.gov Identifier: NCT03616600
• Other Study ID Numbers: HongKongPU_Optometry2
• First Posted: Aug 6, 2018
• Last Update Posted: Feb 10, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Henry HL Chan, PhD, Assocaite Professor, The Hong Kong Polytechnic University: Myopia; Orthokeratology
• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Arm/Group Title	Treatment	Control
Arm/Group Description	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	Not wearing any contact lenses
Period Title: Overall Study
STARTED	16	15
COMPLETED	15	15
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Treatment	Control	Total
Arm/Group Description	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	Not wearing any contact lenses	Total of all reporting groups
Overall Participants	15	15	30
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	15 100%	15 100%	30 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	19.8 (0.7)	22.2 (2.4)	21.1 (2.1)
Sex: Female, Male (Count of Participants)
Female	11 73.3%	9 60%	20 66.7%
Male	4 26.7%	6 40%	10 33.3%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
Hong Kong	15 100%	15 100%	30 100%
Refractive errors (Diopters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Diopters]	-3.47 (1.01)	-3.71 (1.76)	-3.61 (1.40)

Outcome Measures

1. Primary Outcome

Title	Corneal Biomechanics in Terms of Corneal Hysteresis and Resistance Factor
Description	measured by ocular response analyser
Time Frame	Baseline, 1st Month, 3rd Month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment	Control
Arm/Group Description	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	Group randomly selected not to wear any contact lenses
Measure Participants	15	15
Corneal Hysteresis_Baseline	11.12 (1.12)	11.10 (1.36)
Corneal Hysteresis_1st Month	10.37 (1.36)	11.20 (1.89)
Corneal Hysteresis_3rd Month	10.14 (0.89)	11.19 (1.66)
Corneal Resistance Factor_Baseline	11.07 (1.32)	11.14 (2.23)
Corneal Resistance Factor_1st Month	9.87 (1.45)	10.92 (2.45)
Corneal Resistance Factor_3rd Month	9.99 (1.37)	10.79 (2.17)

2. Primary Outcome

Title	Corneal Endothelial Health in Terms of Endothelial Cell Density
Description	measured by specular microscope
Time Frame	Baseline, 1st Month, 3rd Month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment	Control
Arm/Group Description	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	Group randomly selected not to wear any contact lenses
Measure Participants	15	15
Corneal Endothelial Cell Density_Baseline	2909 (145.1)	2861 (181.05)
Corneal Endothelial Cell Density_1st month	2923 (123.01)	2818 (182.65)
Corneal Endothelial Cell Density_3rd month	2917 (157.34)	2825 (177.80)

3. Secondary Outcome

Title	Best Corrected Visual Acuity in Terms of High and Low Contrast
Description	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)
Time Frame	Baseline, 1st Month and the 3rd Month

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Treatment
Arm/Group Description	Group randomly selected to wear the Breath-O Correct lenses
Measure Participants	15
High contrast VA_Baseline	-0.10 (0.06)
High contrast VA_1st Month	-0.07 (0.08)
High contrast VA_3rd Month	-0.08 (0.08)
Low contrast VA_Basline	0.08 (0.08)
Low contrast VA_1st Month	0.22 (0.14)
Low contrast VA_3rd Month	0.17 (0.13)

4. Secondary Outcome

Title	Reduction of the Refractive Power After Wearing the Breath-O-correct Lens
Description	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)
Time Frame	Baseline, 1st Week, 1st Month, 3rd Month

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Treatment
Arm/Group Description	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
Measure Participants	15
Refractive errors_Baseline	-3.52 (1.02)
Refractive errors_1st Week	-0.17 (0.99)
Refractive errors_1st Month	-0.11 (0.92)
Refractive errors_3rd Month	-0.03 (0.82)

5. Primary Outcome

Title	Corneal Endothelial Health in Terms of Percentage of Variation in Cell Size
Description	measured by specular microscope
Time Frame	Baseline, 1st Month, 3rd Month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment	Control
Arm/Group Description	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	Group randomly selected not to wear any contact lenses
Measure Participants	15	15
Corneal Endothelial Cell Variance_Baseline	28.68 (3.78)	29.35 (3.66)
Corneal Endothelial Cell Variance_1st month	28.47 (3.51)	29.00 (3.58)
Corneal Endothelial Cell Variance_3rd month	29.00 (6.53)	30.01 (3.32)

6. Primary Outcome

Title	Anterior Ocular Health in Terms of Limbal and Bulbar Redness
Description	measured 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
Time Frame	Baseline, 1st Month, 3rd Month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment	Control
Arm/Group Description	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	Group randomly selected not to wear any contact lenses
Measure Participants	15	15
Bulbar redness_Baseline	0.57 (0.18)	0.58 (0.28)
Bulbar redness_1st Month	0.47 (0.19)	0.52 (0.21)
Bulbar redness_3rd Month	0.54 (0.31)	0.61 (0.27)
Limbal redness_Baseline	0.26 (0.19)	0.29 (0.26)
Limbal redness_1st Month	0.23 (0.15)	0.31 (0.21)
Limbal redness_3rd Month	0.27 (0.21)	0.38 (0.28)

7. Primary Outcome

Title	Anterior Ocular Surface Evaluation in Terms of Non-invasive Keratography Break-up Time (NIKBUT)
Description	measured by OCULUS Keratograph® 5M
Time Frame	Baseline, 1st Month, 3rd Month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment	Control
Arm/Group Description	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	Group randomly selected not to wear any contact lenses
Measure Participants	15	15
NIKBUT_1st break_Baseline	6.72 (3.96)	9.92 (6.76)
NIKBUT_1st break_1st Month	9.13 (5.45)	9.17 (5.63)
NIKBUT_1st break_3rd Month	9.83 (6.37)	7.64 (4.97)
NIKBUT_average_Baseline	10.94 (4.15)	13.24 (6.56)
NIKBUT_average_1st Month	12.42 (5.73)	11.86 (5.99)
NIKBUT_average_3rd Month	12.07 (6.76)	9.57 (5.02)

Adverse Events

Time Frame	3 months
Arm/Group Title	Treatment		Control
Arm/Group Description	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		Not wearing any contact lenses
All Cause Mortality
	Treatment		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/15 (0%)
Serious Adverse Events
	Treatment		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	Treatment		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/16 (6.3%)		0/15 (0%)
Eye disorders
poor visual quality	1/16 (6.3%)		0/15 (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.