Myopia
Conditions
Brief summary
This study is to investigate whether novel soft contact lens optical designs can slow myopia progression
Interventions
DEVICESoft Contact Test Lens A
FDA-approved, non-marketed daily disposable soft contact lens, conventional design
DEVICESoft Contact Test Lens C
Daily disposable soft contact lens with new optical design
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
Yes
Inclusion criteria
1. The subject must be between 8 and 12 years of age. 2. At least one of the subject's parents or legal guardian must read and understand English or Chinese. 3. The subject's manifest objective refraction (measured with an auto refractor) must be sphere: between -0.25D and -4.50D, and cylinder: \<1.50D in each eye. 4. The subject's best sphere contact lens correction must lie between -0.75D (better of the two eyes)and -4.25D (poorer of the two eyes). 5. The subject's cycloplegic objective refraction must be here: between -0.75D and -4.00D cylinder: \< or equal to 1.00D in each eye. 6. The subject must have 1.00D or less difference in spherical equivalent between the two eyes with cycloplegic refraction. 7. The subject must have a spectacle lens best-corrected visual acuity of 0.8 (20/25) or better in both eyes. 8. The subject's parent or legal guardian must read and sign the STAEMENT OF INFORMED CONSENT and the subject must read and sign the Child's Assent Form and be provided a copy of each form. 9. The subject must appear able and willing to adhere to the instructions set forth in this 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 medications (e.g. antihistamine), which may interfere with contact lens wear. 3. 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. 4. Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection that might interfere with 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 an immunosuppressive disease (e.g. HIV) 8. Diabetes 9. Anisometropia of greater than 1.00D by cycloplegic refraction. 10. Astigmatism of greater than 1.00D in either eye by cycloplegic refraction. 11. Eye injury or surgery within eight weeks immediately prior to enrollment for this study. 12. Previous refractive surgery, orthokeratology, keratoconus, or other corneal irregularity in either eye. Rigid contact lens wearers cannot be enrolled in the study unless they are off rigid contact lenses for at least 4 weeks. 13. Strabismus in either eye. 14. Pupil or lid abnormality or infection in either eye 15. Central corneal scar in either eye 16. Aphakia in either eye 17. Contraindications to contact lens wear such as dry eye or history of prior unsuccessful contact lens wear. 18. History of participation in prior clinical trials aimed to control myopia progression. 19. Surgically altered eyes, ocular infection of any type, ocular inflammation. 20. An anterior chamber angle grade 2 or narrower by the Van Herrick method
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Spherical Equivalent Refractive Error | Baseline and every 6 months post-baseline for 2 years | Cycloplegic spherical equivalent auto refraction of the subject's right eye was computed from the sphero-cylindrical refraction measured with an open-field auto refractor. The median of 3 repeated measures, each of which was the average of 3 consecutive readings, was used for the analysis. Higher values in spherical refraction indicate progression in Myopia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Axial Length | Baseline and every 6 months for 2 years | Axial length was measured with the IOLMaster at baseline and every 6 months for 2 years. Five measurements were collected for each visit from the subject's right eye and the average of the five measurements was used for the analysis. |
Countries
United States
Participant flow
Pre-assignment details
Of those 174 screened subjects, 42 were ineligible to participate in the study and 5 eligible subjects did not randomize to the study arm.
Participants by arm
| Arm | Count |
|---|---|
| Test Lens A Test lenses will be worn in a daily wear modality | 63 |
| Test Lens C Test lens will be worn in a daily wear modality | 64 |
| Total | 127 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lens discomfort | 0 | 3 |
| Overall Study | Lens handling difficulty | 1 | 4 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Protocol Violation | 4 | 1 |
| Overall Study | Relocation | 0 | 1 |
| Overall Study | Subject was fit for ortho - k | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 3 |
Baseline characteristics
| Characteristic | Test Lens C | Test Lens A | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 64 Participants | 63 Participants | 127 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 9.7 years STANDARD_DEVIATION 1.1 | 9.7 years STANDARD_DEVIATION 1.1 | 9.7 years STANDARD_DEVIATION 1.1 |
| Region of Enrollment United States | 64 Participants | 63 Participants | 127 Participants |
| Sex: Female, Male Female | 34 Participants | 34 Participants | 68 Participants |
| Sex: Female, Male Male | 30 Participants | 29 Participants | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 132 |
| serious Total, serious adverse events | 0 / 132 |
Outcome results
Primary
Spherical Equivalent Refractive Error
Cycloplegic spherical equivalent auto refraction of the subject's right eye was computed from the sphero-cylindrical refraction measured with an open-field auto refractor. The median of 3 repeated measures, each of which was the average of 3 consecutive readings, was used for the analysis. Higher values in spherical refraction indicate progression in Myopia.
Time frame: Baseline and every 6 months post-baseline for 2 years
Population: Analysis was conducted on all randomized subjects who have at least one data point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Lens A | Spherical Equivalent Refractive Error | Change from baseline 6 months | -0.386 diopter (D) | Standard Error 0.327 |
| Test Lens A | Spherical Equivalent Refractive Error | Change from baseline 12 months | -0.679 diopter (D) | Standard Error 0.5253 |
| Test Lens A | Spherical Equivalent Refractive Error | Change from baseline 18 months | -0.934 diopter (D) | Standard Error 0.4761 |
| Test Lens A | Spherical Equivalent Refractive Error | Change from baseline 24 months | -1.054 diopter (D) | Standard Error 0.4559 |
| Test Lens C | Spherical Equivalent Refractive Error | Change from baseline 24 months | -1.080 diopter (D) | Standard Error 0.68 |
| Test Lens C | Spherical Equivalent Refractive Error | Change from baseline 6 months | -0.185 diopter (D) | Standard Error 0.2873 |
| Test Lens C | Spherical Equivalent Refractive Error | Change from baseline 18 months | -0.614 diopter (D) | Standard Error 0.414 |
| Test Lens C | Spherical Equivalent Refractive Error | Change from baseline 12 months | -0.548 diopter (D) | Standard Error 0.405 |
Secondary
Axial Length
Axial length was measured with the IOLMaster at baseline and every 6 months for 2 years. Five measurements were collected for each visit from the subject's right eye and the average of the five measurements was used for the analysis.
Time frame: Baseline and every 6 months for 2 years
Population: Analysis was conducted on all randomized subjects who have at least one data point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Lens A | Axial Length | Change from baseline 6 months | 0.172 millimeter (mm) | Standard Deviation 0.1029 |
| Test Lens A | Axial Length | Change from baseline 12 months | 0.371 millimeter (mm) | Standard Deviation 0.1471 |
| Test Lens A | Axial Length | Change from baseline 18 months | 0.479 millimeter (mm) | Standard Deviation 0.2049 |
| Test Lens A | Axial Length | Change from baseline 24 months | 0.545 millimeter (mm) | Standard Deviation 0.2177 |
| Test Lens C | Axial Length | Change from baseline 24 months | 0.514 millimeter (mm) | Standard Deviation 0.2808 |
| Test Lens C | Axial Length | Change from baseline 6 months | 0.061 millimeter (mm) | Standard Deviation 0.1038 |
| Test Lens C | Axial Length | Change from baseline 18 months | 0.313 millimeter (mm) | Standard Deviation 0.1946 |
| Test Lens C | Axial Length | Change from baseline 12 months | 0.229 millimeter (mm) | Standard Deviation 0.1581 |