Myopia
Conditions
Brief summary
This study is to investigate whether novel soft contact lens optical designs can slow myopia progression.
Interventions
DEVICETest Soft Contact Lens B
Test lenses to be worn in daily wear modality
DEVICETest Soft Contact Lens C
Test lenses to be worn in a daily wear modality
DEVICEActive Comparator
Control spectacle lenses to be worn in a daily wear modality
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
1. The subject must be between 8 and 12 years of age and of Asia origin. 2. The subject's best sphere contact lens correction must lie between -0.75D (best of the two eyes) and -5.00D (worst of the two eyes) 3. Astigmatism must be less than or equal to 1.00D 4. Less than 1.00D difference in spherical equivalent between the two eyes 5. The subject must have a best-corrected visual acuity of 20/25 and spherical equivalent refraction visual acuity of 20/25 or better in both eyes 6. The subject must have at least 8D of accommodation. 7. The subject's parent or legal guardian must read and sign the STATEMENT OF INFORMED CONSENT and the subject must read and sign the Child's Assent Form and be provided a copy of each form 8. The subject must appear able and willing to adhere to the instructions set forth in the clinical protocol
Exclusion criteria
1. Ocular or systemic allergies or diseases that may interfere with contact lens wear 2. Systemic disease or autoimmune disease or use of medication (e.g. antihistamines), which may interfere with contact lens wear. 3. Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection that might interfere with contact lens wear. 4. Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormality of the cornea, which may contraindicate contact lens wear. 5. Any ocular infection. 6. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. 7. Any infectious disease (e.g. hepatitis, tuberculosis) or immunosuppressive disease (e.g. HIV). 8. Diabetes. 9. Anismetropia. 10. Astigmatism of greater than 1.00D in either eye. 11. Eye injury or eye surgery within eight weeks immediately prior to enrollment for this study. 12. Previous refractive surgery, rigid contact lens wear, orthokeratology, keratoconus, or other corneal irregularity in either eye 13. Strabismus in either eye 14. Pupil or lid abnormality or infection in either eye 15. Central corneal scar and aphakia in either eye 16. Contraindications to contact lens wear such as dry eye or history of prior unsuccessful contact lens wear 17. History of participation in clinical trials aimed to control myopia progression 18. Surgically altered eyes, ocular infection of any type, ocular inflammation 19. Subject has anterior chamber angle grade 2 or narrower
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Axial Length (Axial Elongation) | Baseline and every 6 months post-baseline up to 3 years | Axial Length was measured with the IOLMaster at baseline, and then every 6 months throughout the course of the study. Five measurements were collected for each eye at each visit and the average of the 5 measurements were used for the analysis. Higher values of axial elongation indicate worse vision. |
| Spherical Equivalent Refraction | Baseline and every 6 months post-baseline up to 3 years | Spherical Equivalent Refraction was computed from the sphero-cylindrical refraction measured with an open-field auto refractor. The median of 3 repeated measurements, each of which was the average of 3 consecutive readings, was used for the analysis. Higher values of spherical refraction indicate progression in Myopia. |
Countries
Hong Kong
Participant flow
Pre-assignment details
Of those 221 screened subjects, 56 were ineligible to participate in the study and 13 were eligible but not randomized to the study lens groups.
Participants by arm
| Arm | Count |
|---|---|
| Test Soft Contact Lens B Lenses will be worn in a daily disposable modality | 51 |
| Test Soft Contact Lens C Lenses will be worn in a daily disposable modality | 50 |
| Spectacle Lenses Control spectacle lenses worn daily. | 51 |
| Total | 152 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Anisometropia > -1.00D in spherical equi | 1 | 0 | 0 |
| Overall Study | Decompensated on left exotropia | 0 | 0 | 1 |
| Overall Study | Dryness | 0 | 1 | 0 |
| Overall Study | Lens discomfort | 3 | 0 | 0 |
| Overall Study | Lens handling difficulty | 1 | 2 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 | 1 |
| Overall Study | Near vision blur | 1 | 0 | 0 |
| Overall Study | Protocol Violation | 6 | 0 | 1 |
| Overall Study | Relocation | 1 | 1 | 0 |
| Overall Study | Stroke | 1 | 0 | 0 |
| Overall Study | Unsatisfactory lens fitting performance | 3 | 6 | 0 |
| Overall Study | Unsatisfactory physiological response | 2 | 4 | 0 |
| Overall Study | Unsatisfactory visual response | 1 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 5 | 1 | 2 |
Baseline characteristics
| Characteristic | Test Soft Contact Lens C | Spectacle Lenses | Test Soft Contact Lens B | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 50 Participants | 51 Participants | 51 Participants | 152 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 9.6 years STANDARD_DEVIATION 1.1 | 9.5 years STANDARD_DEVIATION 1.1 | 9.5 years STANDARD_DEVIATION 1.1 | 9.5 years STANDARD_DEVIATION 1.1 |
| Region of Enrollment United States Hong Kong | 50 Participants | 51 Participants | 51 Participants | 152 Participants |
| Sex: Female, Male Female | 31 Participants | 23 Participants | 18 Participants | 72 Participants |
| Sex: Female, Male Male | 19 Participants | 28 Participants | 33 Participants | 80 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 51 | 7 / 51 | 4 / 50 | 0 / 13 |
| serious Total, serious adverse events | 0 / 51 | 0 / 51 | 0 / 50 | 0 / 13 |
Outcome results
Primary
Axial Length (Axial Elongation)
Axial Length was measured with the IOLMaster at baseline, and then every 6 months throughout the course of the study. Five measurements were collected for each eye at each visit and the average of the 5 measurements were used for the analysis. Higher values of axial elongation indicate worse vision.
Time frame: Baseline and every 6 months post-baseline up to 3 years
Population: Analysis was conducted on all randomized subjects who have at least one data point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Spectacle Lenses | Axial Length (Axial Elongation) | Change from baseline 6 months | 0.158 millimeter (mm) | Standard Deviation 0.0981 |
| Spectacle Lenses | Axial Length (Axial Elongation) | Change from baseline 12 months | 0.242 millimeter (mm) | Standard Deviation 0.1448 |
| Spectacle Lenses | Axial Length (Axial Elongation) | Change from baseline 18 months; N=92, N=54, N=72 | 0.348 millimeter (mm) | Standard Deviation 0.2129 |
| Spectacle Lenses | Axial Length (Axial Elongation) | Change from baseline 24 months; N=92, N=54, N=72 | 0.455 millimeter (mm) | Standard Deviation 0.252 |
| Spectacle Lenses | Axial Length (Axial Elongation) | Change from baseline 30 months | 0.565 millimeter (mm) | Standard Deviation 0.2941 |
| Spectacle Lenses | Axial Length (Axial Elongation) | Change from baseline 36 months | 0.640 millimeter (mm) | Standard Deviation 0.3199 |
| Test Soft Contact Lens B | Axial Length (Axial Elongation) | Change from baseline 36 months | 0.634 millimeter (mm) | Standard Deviation 0.3249 |
| Test Soft Contact Lens B | Axial Length (Axial Elongation) | Change from baseline 6 months | 0.144 millimeter (mm) | Standard Deviation 0.0834 |
| Test Soft Contact Lens B | Axial Length (Axial Elongation) | Change from baseline 24 months; N=92, N=54, N=72 | 0.409 millimeter (mm) | Standard Deviation 0.2247 |
| Test Soft Contact Lens B | Axial Length (Axial Elongation) | Change from baseline 30 months | 0.512 millimeter (mm) | Standard Deviation 0.2634 |
| Test Soft Contact Lens B | Axial Length (Axial Elongation) | Change from baseline 12 months | 0.236 millimeter (mm) | Standard Deviation 0.1267 |
| Test Soft Contact Lens B | Axial Length (Axial Elongation) | Change from baseline 18 months; N=92, N=54, N=72 | 0.355 millimeter (mm) | Standard Deviation 0.1837 |
| Test Soft Contact Lens C | Axial Length (Axial Elongation) | Change from baseline 12 months | 0.222 millimeter (mm) | Standard Deviation 0.1288 |
| Test Soft Contact Lens C | Axial Length (Axial Elongation) | Change from baseline 18 months; N=92, N=54, N=72 | 0.344 millimeter (mm) | Standard Deviation 0.1676 |
| Test Soft Contact Lens C | Axial Length (Axial Elongation) | Change from baseline 36 months | 0.512 millimeter (mm) | Standard Deviation 0.3072 |
| Test Soft Contact Lens C | Axial Length (Axial Elongation) | Change from baseline 24 months; N=92, N=54, N=72 | 0.445 millimeter (mm) | Standard Deviation 0.2444 |
| Test Soft Contact Lens C | Axial Length (Axial Elongation) | Change from baseline 6 months | 0.121 millimeter (mm) | Standard Deviation 0.0749 |
| Test Soft Contact Lens C | Axial Length (Axial Elongation) | Change from baseline 30 months | 0.511 millimeter (mm) | Standard Deviation 0.2564 |
Primary
Spherical Equivalent Refraction
Spherical Equivalent Refraction was computed from the sphero-cylindrical refraction measured with an open-field auto refractor. The median of 3 repeated measurements, each of which was the average of 3 consecutive readings, was used for the analysis. Higher values of spherical refraction indicate progression in Myopia.
Time frame: Baseline and every 6 months post-baseline up to 3 years
Population: Analysis was conducted on all randomized subjects who have at least one data point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Spectacle Lenses | Spherical Equivalent Refraction | Change from baseline 6 months | -0.238 diopter (D) | Standard Deviation 0.3443 |
| Spectacle Lenses | Spherical Equivalent Refraction | Change from baseline 12 months | -0.417 diopter (D) | Standard Deviation 0.4557 |
| Spectacle Lenses | Spherical Equivalent Refraction | Change from baseline 36 months | -1.073 diopter (D) | Standard Deviation 0.9922 |
| Spectacle Lenses | Spherical Equivalent Refraction | Change from baseline 18 months | -0.562 diopter (D) | Standard Deviation 0.5841 |
| Spectacle Lenses | Spherical Equivalent Refraction | Change from baseline 24 months | -0.776 diopter (D) | Standard Deviation 0.6185 |
| Spectacle Lenses | Spherical Equivalent Refraction | Change from baseline 30 months | -0.966 diopter (D) | Standard Deviation 0.7592 |
| Test Soft Contact Lens B | Spherical Equivalent Refraction | Change from baseline 24 months | -0.781 diopter (D) | Standard Deviation 0.4447 |
| Test Soft Contact Lens B | Spherical Equivalent Refraction | Change from baseline 30 months | -1.000 diopter (D) | Standard Deviation 0.5485 |
| Test Soft Contact Lens B | Spherical Equivalent Refraction | Change from baseline 18 months | -0.692 diopter (D) | Standard Deviation 0.3965 |
| Test Soft Contact Lens B | Spherical Equivalent Refraction | Change from baseline 6 months | -0.327 diopter (D) | Standard Deviation 0.3038 |
| Test Soft Contact Lens B | Spherical Equivalent Refraction | Change from baseline 36 months | -1.266 diopter (D) | Standard Deviation 0.3193 |
| Test Soft Contact Lens B | Spherical Equivalent Refraction | Change from baseline 12 months | -0.456 diopter (D) | Standard Deviation 0.3733 |
| Test Soft Contact Lens C | Spherical Equivalent Refraction | Change from baseline 36 months | -0.824 diopter (D) | Standard Deviation 0.8244 |
| Test Soft Contact Lens C | Spherical Equivalent Refraction | Change from baseline 6 months | -0.230 diopter (D) | Standard Deviation 0.3436 |
| Test Soft Contact Lens C | Spherical Equivalent Refraction | Change from baseline 18 months | -0.720 diopter (D) | Standard Deviation 0.4988 |
| Test Soft Contact Lens C | Spherical Equivalent Refraction | Change from baseline 24 months | -0.861 diopter (D) | Standard Deviation 0.5504 |
| Test Soft Contact Lens C | Spherical Equivalent Refraction | Change from baseline 30 months | -1.003 diopter (D) | Standard Deviation 0.6829 |
| Test Soft Contact Lens C | Spherical Equivalent Refraction | Change from baseline 12 months | -0.429 diopter (D) | Standard Deviation 0.4199 |