Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a multi-center, randomized, controlled, double-masked, 2x2 cross-over, non-dispensing study to compare visual acuity and lens fit performance.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEST/CONTROL | Experimental | Eligible subjects will randomly be assigned to one of two unique sequences of the two lens types, Test/Control. |
|
| CONTROL/TEST | Experimental | Eligible subjects will randomly be assigned to one of two unique sequences of the two lens types, Control/Test. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EMO-200 | Device | TEST Lens |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Monocular Distance Visual Acuity (logMAR) | Visual acuity on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 meters) under high luminance high contrast lighting condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. Letter-by- letter results calculated the visual performance score for each chart read. LogMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.00 is equivalent to Snellen visual acuity of 20/20. | 10 minutes post lens insertion |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects' Eyes With Acceptable Lens Fit | Lens fit acceptance was assessed post lens fitting for each subject eye using a biomicroscope. Acceptable fit was a binary response where Y=1 if lens fit was deemed acceptable by the investigator and Y=0 otherwise. An unacceptable fit was observed if any of the following criteria were met: 1.) limbal exposure at primary gaze or with extreme eye movement, 2.) edge lift, 3.) excessive movement in primary and up gaze or 4.) insufficient movement in the three conditions- primary gaze, up gaze and Josephson push up. Time Frame 10 minutes post lens insertion |
Not provided
Inclusion Criteria:
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
The subject's parents or legal guardians must read, understand, and sign the STATEMENT OF INFORMED CONSENT (Parental Permission Form and Authorization to Use and Disclose Medical Information). The subject must read (or be read to) and sign the CHILDREN'S ASSENT (Information and Assent Form) 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 12 (inclusive) years of age at the time of screening.
Have normal eyes (i.e., no ocular medications or infections of any type).
Have non-vertex corrected subjective spherical distance refraction in the range of -0.75 D to -4.50 D (inclusive) in each eye.
Have refractive cylinder in the range of 0.00 D to -1.00 D (inclusive) in each eye with any degree of axis, by subjective sphero-cylindrical refraction.
Have sphero-cylindrical best-corrected visual acuity of 0.04 logMAR (20/20-2) or better in each eye, and the difference of sphero-cylindrical best-corrected visual acuity between the two eyes is less than 0.20 logMAR (2 lines).
Have < 1.50 D difference in subjective best-sphere refraction between the two eyes.
Exclusion Criteria:
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| William J. Bogus, OD | Salt Lake City | Utah | 84106 | United States |
Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
Not provided
Not provided
Not provided
Not provided
A total of 60 subjects were enrolled in this study. Of those enrolled, 57 subjects were dispensed both study lenses and completed all study visits.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Test (EMO-200) \Control (EMO-118) | Subjects randomized to this sequence received the Test lens during the first period and then received the Control lens during the second period |
| FG001 | Control (EMO-118) \Test (EMO-200) | Subjects randomized to this sequence received the Control lens during the first period and then received the Test lens during the second period |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| |||||||||||||
| Period 2 |
|
All subjects dispensed a study lens
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Total | All subjects dispensed a study lens |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Monocular Distance Visual Acuity (logMAR) | Visual acuity on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 meters) under high luminance high contrast lighting condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. Letter-by- letter results calculated the visual performance score for each chart read. LogMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.00 is equivalent to Snellen visual acuity of 20/20. | Subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | logMAR | 10 minutes post lens insertion | Eyes | Eyes |
|
Throughout the duration of the study; The study duration for each subject is approximately 3 hours within 1 day.
All subjects dispensed at least 1 study lens.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test (EMO-200) | Subjects that wore the Test lens in either the first or second period of the study. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Xu Cheng | Johnson & Johnson Vision Care, Inc. (JJVC) | 1-800-843-2020 | xcheng6@its.jnj.com |
Not provided
| 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 | May 6, 2021 | Jul 16, 2024 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| EMO-118 |
| Device |
CONTROL Lens |
|
| 10 minutes post lens insertion |
| NOT COMPLETED |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 |
| Control (EMO-118) |
Subjects that wore the Control lens in either the first or second period of the study. |
|
|
|
| Secondary | Percentage of Subjects' Eyes With Acceptable Lens Fit | Lens fit acceptance was assessed post lens fitting for each subject eye using a biomicroscope. Acceptable fit was a binary response where Y=1 if lens fit was deemed acceptable by the investigator and Y=0 otherwise. An unacceptable fit was observed if any of the following criteria were met: 1.) limbal exposure at primary gaze or with extreme eye movement, 2.) edge lift, 3.) excessive movement in primary and up gaze or 4.) insufficient movement in the three conditions- primary gaze, up gaze and Josephson push up. Time Frame 10 minutes post lens insertion | All subjects that were fitted at least one study lens | Posted | Number | Percentage of acceptable lens fit | 10 minutes post lens insertion | Eyes | Eyes |
|
|
|
|
| 0 |
| 57 |
| 0 |
| 57 |
| 0 |
| 57 |
| EG001 | Control (EMO-118) | Subjects that wore the Control lens in either the first or second period of the study. | 0 | 57 | 0 | 57 | 0 | 57 |
Not provided