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| ID | Type | Description | Link |
|---|---|---|---|
| DISP-523 | Other Identifier | Visioncare Research Ltd |
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| Name | Class |
|---|---|
| Johnson & Johnson K.K. Medical Company | INDUSTRY |
| Visioncare Research Ltd. | OTHER |
This study seeks to evaluate and compare the clinical performance of two daily disposable soft contact lenses, Proclear 1 Day and 1-Day Acuvue Moist.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| etafilcon A/omafilcon A | Active Comparator | etafilcon A contact lenses will be worn during the first week and omafilcon A contact lenses will be worn during the second. Lenses were replaced daily |
|
| omafilcon A/etafilcon A | Active Comparator | omafilcon A contact lenses will be worn during the first week and etafilcon A contact lenses will be worn during the second. Lenses were replaced daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etafilcon A | Device | 1-day soft contact lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Rating of Comfort | This outcome is a weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response. | after 1 week of lens wear |
| Vision Quality | This outcome is a weighted combined score calculated from individual vision-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response. | after 1 week of lens wear |
| Subjective Rating of Handling | This outcome is a weighted combined score calculated from individual lens handling-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response. | after 1 week of lens wear |
| Corneal Staining | Investigator assessment of the corneal staining. Staining is an indication of dryness on areas on the cornea. Here it is measured over 5 regions of the cornea: central, temporal, nasal, inferior, and superior. The staining is graded using the National Eye Institute (NEI)0-3 scale: grade 0 = normal, grade 1 = mild, grade 2 = moderate, grade 3 = severe. | after 1 week of lens wear |
| Subjective Rating of Quality Perceptions | This outcome is a weighted combined score calculated from individual quality perception-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response. | after 1 week of lens wear |
| Limbal Hyperemia | This outcome is assessed by the investigator during biomicroscopy examination using the following 0-4 scale: 0 = none, 1 = trace, 2 = mild, 3= moderate, 4 = severe. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Danny Sim, Diploma in Optometry | Singapore Polytechnic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Singapore Plytechnic | Singapore | 139651 | Singapore |
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| ID | Title | Description |
|---|---|---|
| FG000 | Etafilcon A/Omafilcon A | etafilcon A contact lenses will be worn first and omafilcon A contact lenses will be worn second. |
| FG001 | Omafilcon A/Etafilcon A | omafilcon A contact lenses will be worn first and etafilcon A contact lenses will be worn second. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| ||||||||||||||||||
| Second Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | Total Number of Participants | This represents all subjects that completed the study minus one additional subject excluded due the discovery after study completion that the subject conflicted with exclusion criteria. |
| 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 | Subjective Rating of Comfort | This outcome is a weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response. | The analysis population represents subjects that completed the study per protocol. | Posted | Least Squares Mean | Standard Error | Units on a scale | after 1 week of lens wear |
|
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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 | Etafilcon A | soft contact lens replaced daily, worn for one week. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wakana Katabami | Johnson and Johnson K.K. | 81-34411-8040 | 22025 | wkatabam@its.jnj.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| omafilcon A | Device | 1-day soft contact lens |
|
| after 1 week of wear |
| NOT COMPLETED |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
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|
|
| Primary | Vision Quality | This outcome is a weighted combined score calculated from individual vision-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response. | The analysis population represents subjects that completed the study per protocol. | Posted | Least Squares Mean | Standard Error | Units on a scale | after 1 week of lens wear |
|
|
|
|
| Primary | Subjective Rating of Handling | This outcome is a weighted combined score calculated from individual lens handling-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response. | The analysis population represents subjects that completed the study per protocol. | Posted | Least Squares Mean | Standard Error | Units on a scale | after 1 week of lens wear |
|
|
|
|
| Primary | Corneal Staining | Investigator assessment of the corneal staining. Staining is an indication of dryness on areas on the cornea. Here it is measured over 5 regions of the cornea: central, temporal, nasal, inferior, and superior. The staining is graded using the National Eye Institute (NEI)0-3 scale: grade 0 = normal, grade 1 = mild, grade 2 = moderate, grade 3 = severe. | The analysis population represents subjects that completed the study per protocol. | Posted | Least Squares Mean | Standard Error | Units on a scale | after 1 week of lens wear |
|
|
|
|
| Primary | Subjective Rating of Quality Perceptions | This outcome is a weighted combined score calculated from individual quality perception-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response. | The analysis population represents subjects that completed the study per protocol. | Posted | Least Squares Mean | Standard Error | Units on a scale | after 1 week of lens wear |
|
|
|
|
| Primary | Limbal Hyperemia | This outcome is assessed by the investigator during biomicroscopy examination using the following 0-4 scale: 0 = none, 1 = trace, 2 = mild, 3= moderate, 4 = severe. | The analysis population represents subjects that completed the study per protocol. | Posted | Least Squares Mean | Standard Error | Units on a scale | after 1 week of wear |
|
|
|
|
| 0 |
| 116 |
| 0 |
| 116 |
| EG001 | Omafilcon A | soft contact lens replaced daily, worn for one week. | 0 | 116 | 0 | 116 |
The results of the study may not be published or publicly presented without prior written approval of the sponsor. If the investigator wishes to publish or present any study findings, investigator shall contact sponsor to discuss publication plan.