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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEST arm | Experimental | For subjects enrolled in the Test arm, the Test Soft Contact Lens will be bilaterally fitted to the subject's eyes. Endpoint measures will be collected over one eye only - Test Arm: OD only. |
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| CONTROL arm | Experimental | Subjects enrolled in the Control Arm will be established orthokeratology lens wearers. Endpoint measures will be collected over one eye only - Control Arm: Better OK fitted eyes based on investigator's judgement. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etafilcon A | Device | Test Soft Contact Lens |
| |
| Habitual Orthokeratology Lenses |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to Post Lens Fitting Evaluation |
| 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. | Up to Post Lens Fitting Evaluation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
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.
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.
Appear able and willing to adhere to the instructions set forth in this clinical protocol.
Between 7 and 25 years of age (inclusive).
Have normal eyes (i.e., no ocular medications or infections of any type).
Vertex-corrected distance subjective best-sphere refraction must be between -1.00D and -5.00D (inclusive) in each eye.
Cylindrical refraction must be 1.00D or less in each eye, by subjective sphero-cylindrical refraction.
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:
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:
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 exclusion criteria are for subjects to be enrolled to the Test group only 13 . Current or recent (within 30 days from enrollment) rigid lens wearers. 14 . History of orthokeratology treatment. 15. Any corneal distortion resulting from ocular diseases or previous hard or rigid gas permeable contact lens wear.
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| Name | Affiliation | Role |
|---|---|---|
| Xu Cheng | Johnson & Johnson Vision Care, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Ocular Research & Education | Waterloo | Ontario | Canada |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test | Subjects were fit with the Test lens at Visit 2 of the study |
| FG001 | Control | Existing Orthokeratology patients who have >=5 mm pupil size at Visit 1 Baseline. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All subjects dispensed a study lens
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| ID | Title | Description |
|---|---|---|
| BG000 | Test | Subjects were fit with the Test lens at Visit 2 of the study |
| BG001 | Control | Existing Orthokeratology patients who have >=5 mm pupil size at Visit 1 Baseline. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | micron | Up to Post Lens Fitting Evaluation | Eyes | Eyes |
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Throughout the duration of the study; approximately 2 days up to 10 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test | Subjects were fit with the Test lens at Visit 2 of the study | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Xu Cheng, MD, PhD, FAAO - Sr. Principal Clinical Scientist | Johnson & Johnson Vision Care | 1-800-843-2020 | xcheng6@its.jnj.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 5, 2018 | Oct 27, 2021 | Prot_SAP_000.pdf |
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| Device |
CONTROL |
|
| Up to Post Lens Fitting Evaluation |
| 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. | Up to Post Lens Fitting Evaluation |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Control | Existing Orthokeratology patients who have >=5 mm pupil size at Visit 1 Baseline. |
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| 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. | 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. | Posted | Mean | Standard Deviation | micron | Up to Post Lens Fitting Evaluation | Eyes | Eyes |
|
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|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Diopter | Up to Post Lens Fitting Evaluation | Eyes | Eyes |
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|
| 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. | 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. | Posted | Mean | Standard Deviation | Diopter | Up to Post Lens Fitting Evaluation | Eyes | Eyes |
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| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Control | Existing Orthokeratology patients who have >=5 mm pupil size at Visit 1 Baseline. | 0 | 8 | 0 | 8 | 0 | 8 |
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Statistically significance of difference. Statistical difference will be concluded if the lower limit was greater than 0 or the upper limit was less than 0.
| -10 |
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| +10 |
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| +20 |
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| +30 |
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| At +30° | Mixed Models Analysis | Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom. | Least Square Mean Difference | 2.431 | Standard Error of the Mean | 0.431 | 2-Sided | 95 | 1.585 | 3.277 | Mean difference was calculated as Test - Control | Other | Statistically significance of difference. Statistical difference would be concluded if the lower limit was greater than 0 or the upper limit was less than 0. |
| At +30° | Mixed Models Analysis | Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom. | Least Square Mean Difference | 1.414 | Standard Error of the Mean | 0.603 | 2-Sided | 95 | 0.228 | 2.599 | Mean Difference was calculated as Test - Control | Other | Statistically significance of difference. Statistical difference would be concluded if the lower limit was greater than 0 or the upper limit was less than 0. |