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This is a single visit, randomized, double masked, bilateral, non-dispensing, 2×2 crossover study to assess visual acuity.
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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 the TEST lubricating eye drops, with a washout period of 90 minutes between instillations. After the wash-out period, the CONTROL lubricating eye drops will be instilled. |
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| Control/Test | Experimental | Eligible subjects who are habitual soft contact lens wearers will be randomized into the Test/Control sequence, to receive the CONTROL lubricating eye drops, with a washout period of 90 minutes between instillations. After the wash-out period, the TEST lubricating eye drops will be instilled. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blink® Tears eye drops | Drug | Control Drops |
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| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity (logMAR) at 3 Minutes Post Instillation | High contrast bright illumination monocular logMAR (Logarithm of the Minimum Angle of Resolution) visual acuity was assessed at distance (4 meters) using ETDRS Charts, near (40 cm) and intermediate (64 cm) using reduced Guillon-Poling charts. A value of 0.0 logMAR indicated a Snellen vision of 20/20. Lower logMAR visual acuity values indicate better vision. The average logMAR visual acuity for each treatment was reported. | 3 minutes post instillation |
| Visual Acuity (logMAR) at 10 Minutes Post Instillation | High contrast bright illumination monocular logMAR (Logarithm of the Minimum Angle of Resolution) visual acuity was assessed at distance (4 meters) using ETDRS Charts, near (40 cm) and intermediate (64 cm) using reduced Guillon-Poling charts. A value of 0.0 logMAR indicated a Snellen vision of 20/20. Lower logMAR visual acuity values indicate better vision. The average logMAR visual acuity for each treatment was reported. | 10 minutes post instillation |
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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 who meet any of the following criteria will be excluded from participating in the study:
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 |
|---|---|---|---|---|---|---|
| Vue Optical Boutique | Jacksonville | Florida | 32205 | United States | ||
| St. Johns Eye Associates, P.A. |
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 32 subjects were enrolled from two clinical sites in this study. Of those enrolled, a total of 31 (96.9%) subjects were randomly assigned among 2 unique eye drop sequences, study eye drops administered in both eyes for all subjects and were included in Safety Population; while, one (3.1%) subject was a screen failure and/or not assigned. Of the total assigned subjects, all 31 (96.9%) subjects completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Investigational Lipid Drop\Blink Tears | Subjects randomized to this sequence received Investigational Lipid Drop during the first period and then received Blink Tears during the second period |
| FG001 | Blink Tears\Investigational Lipid Drop |
| 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 | Aug 19, 2020 |
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| Investigational lipid eye drops |
| Drug |
Test Drops |
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| Saint Augustine |
| Florida |
| 32092 |
| United States |
Subjects randomized to this sequence received Blink Tears during the first period and then received Investigational Lipid Drop during the second period |
| COMPLETED |
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| NOT COMPLETED |
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| Period 2 |
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All subjects who instilled at least one eye drop
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| ID | Title | Description |
|---|---|---|
| BG000 | Total | All subjects who instilled at least one eye drop. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
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| 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 | Number | 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 | Visual Acuity (logMAR) at 3 Minutes Post Instillation | High contrast bright illumination monocular logMAR (Logarithm of the Minimum Angle of Resolution) visual acuity was assessed at distance (4 meters) using ETDRS Charts, near (40 cm) and intermediate (64 cm) using reduced Guillon-Poling charts. A value of 0.0 logMAR indicated a Snellen vision of 20/20. Lower logMAR visual acuity values indicate better vision. The average logMAR visual acuity for each treatment was reported. | Subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | LogMAR | 3 minutes post instillation | Eyes | Eyes |
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| Primary | Visual Acuity (logMAR) at 10 Minutes Post Instillation | High contrast bright illumination monocular logMAR (Logarithm of the Minimum Angle of Resolution) visual acuity was assessed at distance (4 meters) using ETDRS Charts, near (40 cm) and intermediate (64 cm) using reduced Guillon-Poling charts. A value of 0.0 logMAR indicated a Snellen vision of 20/20. Lower logMAR visual acuity values indicate better vision. The average logMAR visual acuity for each treatment was reported. | Subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | LogMAR | 10 minutes post instillation | Eyes | Eyes |
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Throughout the duration of the study; The study duration for each subject is approximately 3 hours within 1 day.
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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 | Investigational Lipid Drop | Subjects who instilled the Investigational Lipid Drop in the first or second period of the study. | 0 | 31 | 0 | 31 | 0 | 31 |
| EG001 | Blink Tears | Subjects who instilled the Blink Tears in the first or second period of the study. | 0 | 31 | 0 | 31 | 0 | 31 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Research Optometrist, Clinical Sciences | Johnson & Johnson Vision Care | 1 800-843-2020 | njoshi30@its.jnj.com |
| Dec 12, 2023 |
| Prot_SAP_000.pdf |
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