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Due to changes in business priorities, CR-6494 has been withdrawn.
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This will be a prospective, randomized, bilateral eye, crossover, non-masked single site pilot study to compare the severity of symptoms of itching between test and control lens after two weeks of wear.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEST/CONTROL | Experimental | Eligible subjects who suffer from ocular allergies and who wear contact lenses will be randomized into the wear sequence (TEST/CONTROL) to wear the study lenses during each dispensing period (12-16 days). |
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| CONTROL/TEST | Experimental | Eligible subjects who suffer from ocular allergies and who wear contact lenses will be randomized into the wear sequence (CONTROL/TEST) to wear the study lenses during each dispensing period (12-16 days). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TEST Lens | Device | ACUVUE® Theravision® with Ketotifen |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective rating of itchiness | The severity of symptoms of itching will be compared (0-4 itching scale with 0.5 steps) between the test and control lens after 2 weeks of wear. | up to 2-week follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective rating of comfort | Subjective ratings of comfort will be assessed on a 0 to 100 scale after each 2-week wear period. | up to 2-week follow-up |
| Subjective rating of dryness | Subjective ratings of dryness will be assessed on a 0 to 100 scale after each 2-week wear period. |
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Inclusion Criteria:
Potential participants must satisfy all of the following criteria to be enrolled in the study
Exclusion Criteria:
Potential participants who meet any of the following criteria will be excluded from participating in the study:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Vision Care, Inc. Clinical Trial | Johnson & Johnson Vision Care, Inc. | Study Director |
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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
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| CONTROL Lens |
| Device |
1-DAY ACUVUE® MOIST. |
|
| up to 2-week follow-up |
| Subjective rating of vision | Subjective ratings of vision will be assessed on a 0 to 100 scale after each 2-week wear period. | up to 2-week follow-up |
| Subjective rating of handling | Subjective ratings of handling will be assessed on a 0 to 100 scale after each 2-week wear period. | up to 2-week follow-up |
| CLDEQ-8 Questionnaire | CLDEQ-8 is a dry eye questionnaire that asks the participant to reflect and rate their symptoms of eye discomfort and dryness over the past two weeks. A higher composite score indicates more severe dryness and the range is 0-37. | up to 2-week follow-up |
| Comfortable and total CL wear time | Total wearing time and total comfortable wearing time will be recorded after each 2-week wear period. | up to 2-week follow-up |
| Subject Preference Questionnaire | The subject will select their preferred study lens, test lens or control lens. | at the 2-week follow-up |
| MiniRQLQ Questionnaire | The MiniRQLQ is a validated questionnaire that focuses on the impact of allergies on quality of life (QoL). It includes 14 questionnaire items in five sections (activities, practical problems, nasal symptoms, ocular symptoms, general symptoms) that address how allergies impacted QoL during the previous week, by asking the user to rate how troubling each item in the questionnaire was perceived. | up to 2-week follow-up |