Myopia
Conditions
Brief summary
This is a continuation study for subjects who were previously fit with test or control lenses; all will stop wearing their study lenses assigned in the previous study and will start to wear an FDA-approved marketed spherical soft contact lens.
Interventions
DEVICE1 Day Acuvue Moist
Lenses will be worn in a daily wear modality
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Years to 13 Years
Healthy volunteers
Yes
Inclusion criteria
1. The subject must be enrolled in the parent protocol for at least one year. 2. 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. 3. 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 that may interfere with contact lens wear. 2. Systemic disease or autoimmune disease or use of medication (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. Previous refractive surgery, orthokeratology, keratoconus, or other corneal irregularity in either eye. Rigid contact lens wearers cannot be enrolled in the study. 10. Strabismus. 11. Pupil or lid abnormality or infection in either eye 12. Central corneal scar in either eye 13. Aphakia in either eye 14. Contraindications to contact lens wear such as dry eye or history of prior unsuccessful contact lens wear. 15. History of participation in prior clinical trials aimed to control myopia progression, except for the parent trial 16. Surgically altered eyes, ocular infection of any type, ocular inflammation. 17. Anterior chamber angle grade 2 or narrower by Van Herrick method.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Axial Length of the Eye | Baseline and every 6 months post-baseline up to 18 months | Axial length was measured with the IOLMaster at baseline and then every 6 months throughout the course of the study. Five measurements were collected at each visit from the subject's right eye and the average of the 5 measurements was used for the analysis. |
| Spherical Equivalent Refractive Error | Baseline and every 6 months up to 18 months | Cycloplegic spherical equivalent refraction of the subjects's right eye was computed from the sphero-cylindrical refraction measured with an open-field auto refractor. The median of 5 repeated measurements, each of which was the average of 3 consecutive readings, was used for the analysis. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Test Lens C Test lens C from previous study | 40 |
| Test Lens A Test lens A from previous study | 42 |
| Total | 82 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Protocol Violation | 0 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Test Lens C | Test Lens A |
|---|---|---|---|
| Age, Categorical <=18 years | 82 Participants | 40 Participants | 42 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 | 11.1 years STANDARD_DEVIATION 1.2 | 11.1 years STANDARD_DEVIATION 1.2 | 11.0 years STANDARD_DEVIATION 1.2 |
| Region of Enrollment United States | 82 participants | 40 participants | 42 participants |
| Sex: Female, Male Female | 46 Participants | 22 Participants | 24 Participants |
| Sex: Female, Male Male | 36 Participants | 18 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 40 | 0 / 42 |
| serious Total, serious adverse events | 0 / 40 | 0 / 42 |
Outcome results
Primary
Axial Length of the Eye
Axial length was measured with the IOLMaster at baseline and then every 6 months throughout the course of the study. Five measurements were collected at each visit from the subject's right eye and the average of the 5 measurements was used for the analysis.
Time frame: Baseline and every 6 months post-baseline up to 18 months
Population: All subjects who have at least one data point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Lens C | Axial Length of the Eye | Change from baseline at 12 months | 0.229 millimeter (mm) | Standard Deviation 0.1237 |
| Test Lens C | Axial Length of the Eye | Change from baseline at 18 months | 0.272 millimeter (mm) | Standard Deviation 0.1656 |
| Test Lens C | Axial Length of the Eye | Change from baseline at 6 months | 0.080 millimeter (mm) | Standard Deviation 0.0822 |
| Test Lens A | Axial Length of the Eye | Change from baseline at 6 months | 0.073 millimeter (mm) | Standard Deviation 0.0661 |
| Test Lens A | Axial Length of the Eye | Change from baseline at 12 months | 0.231 millimeter (mm) | Standard Deviation 0.1181 |
| Test Lens A | Axial Length of the Eye | Change from baseline at 18 months | 0.255 millimeter (mm) | Standard Deviation 0.1611 |
Primary
Spherical Equivalent Refractive Error
Cycloplegic spherical equivalent refraction of the subjects's right eye was computed from the sphero-cylindrical refraction measured with an open-field auto refractor. The median of 5 repeated measurements, each of which was the average of 3 consecutive readings, was used for the analysis.
Time frame: Baseline and every 6 months up to 18 months
Population: All subjects who have at least one data point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Lens C | Spherical Equivalent Refractive Error | Change from baseline at 6 months | -0.015 diopter (D) | Standard Deviation 0.1911 |
| Test Lens C | Spherical Equivalent Refractive Error | Change from baseline at 12 months | -0.342 diopter (D) | Standard Deviation 0.3136 |
| Test Lens C | Spherical Equivalent Refractive Error | Change from baseline at 18 months | -0.444 diopter (D) | Standard Deviation 0.3866 |
| Test Lens A | Spherical Equivalent Refractive Error | Change from baseline at 6 months | -0.155 diopter (D) | Standard Deviation 0.2101 |
| Test Lens A | Spherical Equivalent Refractive Error | Change from baseline at 12 months | -0.471 diopter (D) | Standard Deviation 0.2991 |
| Test Lens A | Spherical Equivalent Refractive Error | Change from baseline at 18 months | -0.569 diopter (D) | Standard Deviation 0.3718 |