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This is a 30-Day, multi-site, single-masked, bilateral, active- controlled, 2-Arm parallel group study to evaluate the safety and efficacy of an Investigational product.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational product | Experimental | Eligible subjects will be randomly assigned the investigational product to be used in both eyes for the duration of the study. |
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| Control product | Active Comparator | Eligible subjects will be randomly assigned the control product to be used in both eyes for the duration of the study |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational Lubricating Eye Drop in a Novelia® bottle | Drug | Investigational Product |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Overall Quality of Ocular Comfort From Baseline to 30-Day Follow-Up Using VAS Scores | Subjective ocular comfort was assessed at baseline, and at 30-day follow-up using a Visual Analogue Scale (VAS) with continuous scale from 0 (extremely uncomfortable) to 100 (extremely comfortable). The change from baseline ocular comfort score was calculated as 30-day follow-up score minus baseline score. Change from baseline VAS scores range from -100 to 100, where higher change from baseline comfort scores indicates better performance. The average change from baseline comfort score for each Arm was reported. | Baseline and 30-Day Follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Overall Quality of Vision From Baseline to 30-Day Follow-Up Using VAS Scores | Subjective vision was assessed at baseline, and at 30-day follow-up using a Visual Analogue Scale (VAS) with continuous scale from 0 (extremely uncomfortable) to 100 (extremely comfortable). The change from baseline quality of vision score was calculated as 30-day follow-up score minus baseline score. Change from baseline VAS scores range from -100 to 100, where higher change from baseline vision scores indicates better performance. The average change from baseline vision score for each arm was report. |
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Inclusion Criteria:
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
Exclusion Criteria:
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
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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 |
|---|---|---|---|---|---|---|
| Vue Optical Boutique | Jacksonville | Florida | 32205 | United States | ||
| Stam & Associates Eye Care |
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 121 subjects were enrolled in this study. Of those enrolled, 118 subjects were dispensed at least one study eyedrop while 3 subjects failed to meet all eligibility criteria. Of those dispensed, 107 subjects completed the study while 11 subjects were discontinued.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test | Subjects that were randomized to the Test group throughout the duration of the study. |
| FG001 | Control | Subjects that were randomized to the Control group throughout the duration of the study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 25, 2023 |
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| Blink® Tears eye Drops | Drug | Control Product |
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| Baseline and 30-Day Follow-up |
| Jacksonville |
| Florida |
| 32256 |
| United States |
| Kannarr Eye Care | Pittsburg | Kansas | 66762 | United States |
| Complete Eye Care of Medina | Medina | Minnesota | 55340 | United States |
| ProCare Vision Centers | Granville | Ohio | 43023 | United States |
| Total Eye Care | Memphis | Tennessee | 38119 | United States |
| Tyler Eye Associates | Tyler | Texas | 75703 | United States |
| Botetourt Eyecare, LLC | Salem | Virginia | 24153 | United States |
| COMPLETED |
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| NOT COMPLETED |
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All subjects dispensed at least one study eyedrop.
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| ID | Title | Description |
|---|---|---|
| BG000 | Test | Subjects that were randomized to the Test group throughout the duration of the study. |
| BG001 | Control | Subjects that were randomized to the Control group throughout the duration of the study. |
| BG002 | Total | Total of all reporting groups |
| 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 (NIH/OMB) | 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 | Change in Overall Quality of Ocular Comfort From Baseline to 30-Day Follow-Up Using VAS Scores | Subjective ocular comfort was assessed at baseline, and at 30-day follow-up using a Visual Analogue Scale (VAS) with continuous scale from 0 (extremely uncomfortable) to 100 (extremely comfortable). The change from baseline ocular comfort score was calculated as 30-day follow-up score minus baseline score. Change from baseline VAS scores range from -100 to 100, where higher change from baseline comfort scores indicates better performance. The average change from baseline comfort score for each Arm was reported. | All randomized subjects regardless of actual treatment and subsequent withdrawal from the study or deviation from the protocol. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and 30-Day Follow-up |
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| Secondary | Change in Overall Quality of Vision From Baseline to 30-Day Follow-Up Using VAS Scores | Subjective vision was assessed at baseline, and at 30-day follow-up using a Visual Analogue Scale (VAS) with continuous scale from 0 (extremely uncomfortable) to 100 (extremely comfortable). The change from baseline quality of vision score was calculated as 30-day follow-up score minus baseline score. Change from baseline VAS scores range from -100 to 100, where higher change from baseline vision scores indicates better performance. The average change from baseline vision score for each arm was report. | All randomized subjects regardless of actual treatment and subsequent withdrawal from the study or deviation from the protocol. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and 30-Day Follow-up |
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Throughout the entire duration of the study. Approximately 30 Days 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 | Test | Subjects that were randomized to the Test group throughout the duration of the study. | 0 | 58 | 0 | 58 | 0 | 58 |
| EG001 | Control | Subjects that were randomized to the Control group throughout the duration of the study. | 0 | 60 | 0 | 60 | 0 | 60 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Research Optometrist | Johnson & Johnson Vision Care, Inc. (JJVC) | (347) 903-5029 | njoshi30@its.jnj.com |
| Mar 25, 2024 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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Non-inferiority margin of -20 was used.
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