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This is an 8-visit, bilateral, dispensing clinical study to evaluate the change in tear fluid pH and tear film osmolarity in an FDA-cleared contact lens in new contact lens users over a 14-day period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| narafilcon A | Experimental | Subjects who are new contact lens wearers (neophytes) between the ages of 18-45 will be dispensed the Test Lens and evaluated over a period of 2 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Marketed Contact Lens | Device | Narafilcon A |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tear Film Osmolarity | Tear film osmolarity was measured in each subject eye using the TearLab Osmolarity system. The instrument was placed gently into the lower lid temporal tear minuscus without simulating reflex tearing | 2-Week Follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Tear Film Osmolarity | Tear film osmolarity was measured in each subject eye using the TearLab Osmolarity system. The instrument was placed gently into the lower lid temporal tear minuscus without simulating reflex tearing. | 1-Week Follow-up |
| Tear Film PH |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aston University | Birmingham | West Midlands | B4 7ET | United Kingdom |
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A total of 31 subjects were enrolled in this study. Of the enrolled subjects 1 did not meet the eligibility criteria and 30 were dispensed the study lens. Of the dispensed subjects 29 completed the study and 1 subject was discontinued from the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Narafilcon A | All subjects wore the same lens throughout the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All subjects that were dispensed a study lens.
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| ID | Title | Description |
|---|---|---|
| BG000 | Narafilcon A | All subjects wore the same lens throughout the study. |
| 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 | Tear Film Osmolarity | Tear film osmolarity was measured in each subject eye using the TearLab Osmolarity system. The instrument was placed gently into the lower lid temporal tear minuscus without simulating reflex tearing | Subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | mOsm/L | 2-Week Follow-up | Eyes | Eyes |
|
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Throughout the duration of the study. Approximately 2-weeks per subject.
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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 | Narafilcon A | All subjects wore the same lens throughout the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrea Le, OD, MBA - Manager, Global Medical Affairs | Johnson & Johnson Vision Care Inc. | 904 4431866 | ale3@ITS.JNJ.com |
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Tear Film PH was measured using a 1mm Microglass electrode (Thermo Scientific Orion 9810BN) placed gently in lower temporal tear meniscus of non-Schirmer eye without simulating reflex tearing. |
| 1-Week Follow-up |
| Years |
|
| 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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| Eyes |
|
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| Secondary | Tear Film Osmolarity | Tear film osmolarity was measured in each subject eye using the TearLab Osmolarity system. The instrument was placed gently into the lower lid temporal tear minuscus without simulating reflex tearing. | Subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | mOsm/L | 1-Week Follow-up | Eyes | Eyes |
|
|
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| Secondary | Tear Film PH | Tear Film PH was measured using a 1mm Microglass electrode (Thermo Scientific Orion 9810BN) placed gently in lower temporal tear meniscus of non-Schirmer eye without simulating reflex tearing. | Subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | PH value | 1-Week Follow-up |
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| 0 |
| 30 |
| 0 |
| 30 |
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