Visual Acuity
Conditions
Brief summary
This is a two-arm parallel, non-masked, bilateral, non-dispensing study with one Test arm and one concurrent, non-randomized Control arm to evaluate the one-eye optical performances of the test soft contact lens and compare with eyes treated with orthokeratology.
Interventions
DEVICEetafilcon A
Test Soft Contact Lens
DEVICEHabitual Orthokeratology Lenses
CONTROL
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 25 Years
Healthy volunteers
Yes
Inclusion criteria
* Potential subjects must satisfy all of the following criteria to be enrolled in the study: 1. Pediatric subjects (\<18 years old) must read (or be read to), understand, and sign the Statement of Information and Assent and receive a fully executed copy of the form. 2. Adult subjects (≥18 years old) and parent(s) or legal guardian(s) of pediatric subjects must read, understand and sign the Statement of Informed Consent and receive a fully executed copy of the form. 3. Appear able and willing to adhere to the instructions set forth in this clinical protocol. 4. Between 7 and 25 years of age (inclusive). 5. Have normal eyes (i.e., no ocular medications or infections of any type). 6. Vertex-corrected distance subjective best-sphere refraction must be between -1.00D and -5.00D (inclusive) in each eye. 7. Cylindrical refraction must be 1.00D or less in each eye, by subjective sphero-cylindrical refraction. 8. Have sphero-cylindrical best-corrected visual acuity of 20/25 or better in each eye. Below inclusion criterion is for subjects to be enrolled to the Control group only: 9. Are existing orthokeratology patients whose current treatment has been stabilized for at least 1 months and with complete pre-treatment record, e.g., spherocylindrical refraction and corneal topography. Pre-treatment wavefront aberration measures are preferred by not required.
Exclusion criteria
* Potential subjects who meet any of the following criteria will be excluded from participating in the study: 1. Currently pregnant or lactating. 2. Any systemic allergies, infectious disease (e.g., hepatitis, tuberculosis), autoimmune disease (e.g., rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study. 3. Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear and/or participation in the study. 4. Any current use of ocular topical medication (occasional use of re-wetting drops is allowed). 5. Any previous or planned ocular or intraocular surgery, including refractive surgery. 6. Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment. 7. Employee or their children/relatives of investigational clinic (e.g., Investigator, Coordinator, Technician). 8 . Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to, aphakia, uveitis, ocular hypertension, glaucoma, severe keratoconjunctivitis sicca, history of recurrent corneal erosions, keratoconus, keratoconus suspect, pellucid marginal degeneration, entropion, ectropion, extrusions, chalazia, and recurrent styes. 9 . Any Grade 3 or greater slit lamp findings (eg, edema, corneal neovascularization, corneal staining, tarsal abnormalities, and conjunctival injection) on the FDA scale. 10 . Any ocular abnormality that is contraindicated contact lens wear. 11 . Any corneal scar within central 5mm 12 . Binocular vision abnormality, intermittent strabismus or strabismus. Below
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distance Spherical Aberration (Z4, 0) | Up to Post Lens Fitting Evaluation | Spherical aberration (Z4, 0) for a 5-mm pupil was measured by an aberrometer (COAS by AMO) with a distant viewing target at 4 m at the Baseline and post lens fitting. The Control Group only had 1 study Visit that record Baseline measurements, no intervention from the sponsor was implemented for this group, therefore data was collected on a bare eye. The Test group was fitted with the study lens at Visit 2 and data was collected with the Test lens on eye. |
| Near Spherical Aberration (Z4, 0) | Up to Post Lens Fitting Evaluation | Spherical aberration (Z4, 0) for a 5 mm pupil was measured by an aberrometer (COAS by AMO) with a near view target at 25 cm. at the Baseline and post lens fitting. The Control Group only had 1 study Visit that record Baseline measurements, no intervention from the sponsor was implemented for this group, therefore data was collected on a bare eye. The Test group was fitted with the study lens at Visit 2 and data was collected with the Test lens on eye. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distance Off-axis Refraction at ±10°, ±20°, and ±30° Retinal Eccentricities. | Up to Post Lens Fitting Evaluation | Distance off-axis refractions were measured by an open-field autorefractor (WAM-5500 by Grand Seiko) with distant viewing targets at 4 m and ±10°, ±20°, and ±30° off axis. at the Baseline and post lens fitting. The Control Group only had 1 study Visit that record Baseline measurements, no intervention from the sponsor was implemented for this group, therefore data was collected on a bare eye. The Test group was fitted with the study lens at Visit 2 and data was collected with the Test lens on eye. |
| Near Off-axis Refraction at ±30° Retinal Eccentricities. | Up to Post Lens Fitting Evaluation | Near off-axis refractions were measured by an open-field autorefractor (WAM-5500 by Grand Seiko) with near viewing targets at 25 cm and ±30° off-axis. at the Baseline and post lens fitting. The Control Group only had 1 study Visit that record Baseline measurements, no intervention from the sponsor was implemented for this group, therefore data was collected on a bare eye. The Test group was fitted with the study lens at Visit 2 and data was collected with the Test lens on eye. |
Countries
Canada
Participant flow
Recruitment details
A total of 28 subjects were enrolled into this study at 1 clinical site. Of those enrolled, 20 subjects in the test arm were dispensed a study lens while, 8 subjects in the control arm were not dispensed, all 28 subjects who were enrolled have completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Test Subjects were fit with the Test lens at Visit 2 of the study | 20 |
| Control Existing Orthokeratology patients who have \>=5 mm pupil size at Visit 1 Baseline. | 8 |
| Total | 28 |
Baseline characteristics
| Characteristic | Test | Control | Total |
|---|---|---|---|
| Age, Continuous | 17.9 years STANDARD_DEVIATION 3.82 | 16.8 years STANDARD_DEVIATION 4.62 | 17.6 years STANDARD_DEVIATION 4.01 |
| Race/Ethnicity, Customized Asian | 6 participants | 7 participants | 13 participants |
| Race/Ethnicity, Customized Other | 4 participants | 1 participants | 5 participants |
| Race/Ethnicity, Customized White | 10 participants | 0 participants | 10 participants |
| Region of Enrollment Canada | 20 participants | 8 participants | 28 participants |
| Sex: Female, Male Female | 14 Participants | 6 Participants | 20 Participants |
| Sex: Female, Male Male | 6 Participants | 2 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 8 |
| other Total, other adverse events | 0 / 20 | 0 / 8 |
| serious Total, serious adverse events | 0 / 20 | 0 / 8 |
Outcome results
Primary
Distance Spherical Aberration (Z4, 0)
Spherical aberration (Z4, 0) for a 5-mm pupil was measured by an aberrometer (COAS by AMO) with a distant viewing target at 4 m at the Baseline and post lens fitting. The Control Group only had 1 study Visit that record Baseline measurements, no intervention from the sponsor was implemented for this group, therefore data was collected on a bare eye. The Test group was fitted with the study lens at Visit 2 and data was collected with the Test lens on eye.
Time frame: Up to Post Lens Fitting Evaluation
Population: All subjects who were administered any test article excluding subjects who dropped out prior to administering any test article. At least one observation was recorded.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | Distance Spherical Aberration (Z4, 0) | 0.350 micron | Standard Deviation 0.066 |
| Control | Distance Spherical Aberration (Z4, 0) | 0.364 micron | Standard Deviation 0.212 |
Comparison: This was a pilot study for assessing the investigational test articles. As such, the sample size was not determined based on any power analysis with regard to the primary endpoint.95% CI: [-0.081, 0.056]Mixed Models Analysis
Primary
Near Spherical Aberration (Z4, 0)
Spherical aberration (Z4, 0) for a 5 mm pupil was measured by an aberrometer (COAS by AMO) with a near view target at 25 cm. at the Baseline and post lens fitting. The Control Group only had 1 study Visit that record Baseline measurements, no intervention from the sponsor was implemented for this group, therefore data was collected on a bare eye. The Test group was fitted with the study lens at Visit 2 and data was collected with the Test lens on eye.
Time frame: Up to Post Lens Fitting Evaluation
Population: All subjects who were administered any test article excluding subjects who dropped out prior to administering any test article. At least one observation was recorded.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | Near Spherical Aberration (Z4, 0) | 0.300 micron | Standard Deviation 0.061 |
| Control | Near Spherical Aberration (Z4, 0) | 0.272 micron | Standard Deviation 0.144 |
Comparison: This was a pilot study for assessing the investigational test articles. As such, the sample size was not determined based on any power analysis with regard to the primary endpoint.95% CI: [-0.037, 0.1]Mixed Models Analysis
Secondary
Distance Off-axis Refraction at ±10°, ±20°, and ±30° Retinal Eccentricities.
Distance off-axis refractions were measured by an open-field autorefractor (WAM-5500 by Grand Seiko) with distant viewing targets at 4 m and ±10°, ±20°, and ±30° off axis. at the Baseline and post lens fitting. The Control Group only had 1 study Visit that record Baseline measurements, no intervention from the sponsor was implemented for this group, therefore data was collected on a bare eye. The Test group was fitted with the study lens at Visit 2 and data was collected with the Test lens on eye.
Time frame: Up to Post Lens Fitting Evaluation
Population: All subjects who were administered any test article excluding subjects who dropped out prior to administering any test article. At least one observation was recorded.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test | Distance Off-axis Refraction at ±10°, ±20°, and ±30° Retinal Eccentricities. | -30 | 0.3502 Diopter | Standard Deviation 3.79171 |
| Test | Distance Off-axis Refraction at ±10°, ±20°, and ±30° Retinal Eccentricities. | -20 | -1.1344 Diopter | Standard Deviation 1.39215 |
| Test | Distance Off-axis Refraction at ±10°, ±20°, and ±30° Retinal Eccentricities. | -10 | -0.3786 Diopter | Standard Deviation 0.94009 |
| Test | Distance Off-axis Refraction at ±10°, ±20°, and ±30° Retinal Eccentricities. | +10 | -1.4402 Diopter | Standard Deviation 1.2224 |
| Test | Distance Off-axis Refraction at ±10°, ±20°, and ±30° Retinal Eccentricities. | +20 | -1.9654 Diopter | Standard Deviation 1.22837 |
| Test | Distance Off-axis Refraction at ±10°, ±20°, and ±30° Retinal Eccentricities. | +30 | -0.1098 Diopter | Standard Deviation 3.76589 |
| Control | Distance Off-axis Refraction at ±10°, ±20°, and ±30° Retinal Eccentricities. | +20 | -4.4656 Diopter | Standard Deviation 2.07377 |
| Control | Distance Off-axis Refraction at ±10°, ±20°, and ±30° Retinal Eccentricities. | -30 | -3.0756 Diopter | Standard Deviation 1.66232 |
| Control | Distance Off-axis Refraction at ±10°, ±20°, and ±30° Retinal Eccentricities. | +10 | -1.7429 Diopter | Standard Deviation 1.16422 |
| Control | Distance Off-axis Refraction at ±10°, ±20°, and ±30° Retinal Eccentricities. | -20 | -2.4579 Diopter | Standard Deviation 1.9126 |
| Control | Distance Off-axis Refraction at ±10°, ±20°, and ±30° Retinal Eccentricities. | +30 | -2.5638 Diopter | Standard Deviation 2.61755 |
| Control | Distance Off-axis Refraction at ±10°, ±20°, and ±30° Retinal Eccentricities. | -10 | -0.4444 Diopter | Standard Deviation 0.53691 |
Comparison: At -30°95% CI: [2.557, 4.248]Mixed Models Analysis
Comparison: At +30°95% CI: [1.585, 3.277]Mixed Models Analysis
Secondary
Near Off-axis Refraction at ±30° Retinal Eccentricities.
Near off-axis refractions were measured by an open-field autorefractor (WAM-5500 by Grand Seiko) with near viewing targets at 25 cm and ±30° off-axis. at the Baseline and post lens fitting. The Control Group only had 1 study Visit that record Baseline measurements, no intervention from the sponsor was implemented for this group, therefore data was collected on a bare eye. The Test group was fitted with the study lens at Visit 2 and data was collected with the Test lens on eye.
Time frame: Up to Post Lens Fitting Evaluation
Population: All subjects who were administered any test article excluding subjects who dropped out prior to administering any test article. At least one observation was recorded.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test | Near Off-axis Refraction at ±30° Retinal Eccentricities. | +30 | -3.6046 Diopter | Standard Deviation 3.37323 |
| Test | Near Off-axis Refraction at ±30° Retinal Eccentricities. | -30 | -2.3463 Diopter | Standard Deviation 3.1356 |
| Control | Near Off-axis Refraction at ±30° Retinal Eccentricities. | -30 | -5.3558 Diopter | Standard Deviation 2.49516 |
| Control | Near Off-axis Refraction at ±30° Retinal Eccentricities. | +30 | -4.9883 Diopter | Standard Deviation 3.77839 |
Comparison: At -30°95% CI: [1.854, 4.225]Mixed Models Analysis
Comparison: At +30°95% CI: [0.228, 2.599]Mixed Models Analysis