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This will be a single-visit, multi-site, randomized, single-masked, bilateral, active-controlled, non-dispensing, 2X2 crossover study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test/Control | Experimental | Eligible subjects who are habitual soft contact lens wearers will be randomized into the Test/Control sequence, to receive 1-2 drops on each eye (right eye followed by left eye) over soft spherical contact lenses, over two wear periods (test then control). A washout period of 90 minutes between eyedrop instillations will occur. The second eyedrop as per the randomization schedule will follow the same procedure as previously stated. |
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| Control/Test | Experimental | Eligible subjects who are habitual soft contact lens wearers will be randomized into the Control/Test sequence, to receive 1-2 drops on each eye (right eye followed by left eye) over soft spherical contact lenses, over two wear periods (control then test). A washout period of 90 minutes between eyedrop instillations will occur. The second eyedrop as per the randomization schedule will follow the same procedure as previously stated. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blink® Tears eye drops in a multidose bottle | Drug | Control |
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| Measure | Description | Time Frame |
|---|---|---|
| Monocular logMAR Visual Acuity | Monocular visual acuity was measured at distance (4meter) using a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast lighting conditions. VA was assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. Letter-by-letter results calculated the visual acuity score for each chart read. LogMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20. | 10 Minutes Post Eye Drop Administration |
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Inclusion Criteria:
The subject must:
Exclusion Criteria:
The subject must not:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Vision Care, Inc. Clinical Trial | Johnson & Johnson Vision Care, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VRC | Jacksonville | Florida | 32256 | United States | ||
| Maitland Vision Center - North Orlando Ave |
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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A total of 46 subjects were enrolled in this study. Of those enrolled, 44 subjects were dispensed at least one study lens, while 2 subjects failed to meet all eligibility criteria. All 44 dispensed subjects completed the study. 1-2 drops of Test and Control eye drops were administered to both eyes for every subject. This is a single visit study with 90-minute washout between period 1 and 2.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test\Control | Subjects randomized to receive the Test Eye Drop in both eyes during the first period and the Control Eye Drop in both eyes during the second period |
| FG001 | Control\Test |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
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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 | Apr 24, 2023 |
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| Preservative-free investigational lubricating eye drops in a Novelia® eyedropper |
| Drug |
Test |
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| Maitland |
| Florida |
| 32751 |
| United States |
| Tyler Eye Associates | Tyler | Texas | 75703 | United States |
Subjects randomized to receive the Control Eye Drop in both eyes during the first period and the Test Eye Drop in both eyes during the second period
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| Period 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dispensed Subjects | All subjects dispensed at least one study lens |
| 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 | Standard Deviation | 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 | Count of Participants | Participants |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Monocular logMAR Visual Acuity | Monocular visual acuity was measured at distance (4meter) using a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast lighting conditions. VA was assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. Letter-by-letter results calculated the visual acuity score for each chart read. LogMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20. | All subjects who successfully complete all visits and do not substantially deviate from the protocol. | Posted | Mean | Standard Deviation | logMAR | 10 Minutes Post Eye Drop Administration | Eyes | Eyes |
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Throughout the duration of the study; 1 day per subject
All subjects dispensed a study lens.
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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 that received Test (Investigational) eye drop during either period of the study. | 0 | 44 | 0 | 44 | 0 | 44 |
| EG001 | Control | Subjects that received the Control eye drop during either period of the study. | 0 | 44 | 0 | 44 | 0 | 44 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nabin Joshi | Johnson & Johnson Vision Care, Inc. (JJVC) | 1-800-843-2020 | njoshi30@its.jnj.com |
| Apr 18, 2024 |
| Prot_SAP_000.pdf |
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| Native Hawaiian or Other Pacific Islander |
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| White |
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A non-inferiority margin of 0.05 logMAR was used.