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This clinical study is a randomized, double-masked, cross-over, bilateral, 2 treatment x 2 period, dispensing 4-visit study with a 7-9 day washout period in between visits 2 and 3. The study will last approximately 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test/Control | Experimental | Subjects between the ages of 18-69 years of age will sequentially try the Test and Control eye drops in a random order |
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| Control/Test | Experimental | Subjects between the ages of 18-69 years of age will sequentially try the Control and Test eye drops in a random order. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test Eye Drops | Device | blink® intensive TRIPLE ACTION 3 in 1 eye drops |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Comfort | Ocular comfort was measured using the visual analogue scale of 0 to 100. Where 0 is extremely uncomfortable and 100 is extremely comfortable. | 1-Week Follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Dryness Rating | Subjective dryness was assessed using Ocular Surface Disease Index (OSDI©) instrument. Dryness is evaluated on a scale of 0 to 100, where higher scores indicate more symptoms of dryness | 1-Week Follow-up |
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Inclusion Criteria:
Potential subjects must satisfy all the following criteria to be enrolled in the study:
Subjects must be at least 18 years of age and no more than 69 years of age (inclusive)
Subjects must be non-contact lens wearers
Subjects must have a DEQ-5 score of >6 at either Visit 0 (pre-screen) and/or Visit 1 (screening).
Subjects must achieve visual acuity of 20/30 (equivalent to 0.18 logMAR) or better in each eye, either unaided or best corrected.
Subjects must possess a functional/usable pair of spectacles and bring them to every visit (only if applicable - to the investigators discretion).
Subjects must read, understand, and sign the Statement of Informed Consent.
Subjects must appear able and willing to adhere to the instructions set forth in this clinical protocol
Exclusion Criteria:
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
In addition to the above criteria, patients with any allergy or sensitivity to ingredients that this product may contain (liposomes, sodium hyaluronate, vitamin E polyethylene glycol succinate (TPGS), polyethylene glycol 400 (PEG 400), disodium edetate, polyhexanide methylbiguanide, propylene glycol, boric acid, dimyristoyl phosphatidylglycerol, edetate disodium, hydroxypropyl guar, mineral oil, polyoxyl 40 sterate, polyquaternium-1, sorbitan tristearate, sorbitol, hydrochloric acid and/or sodium hydroxide) should not participate in the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Manchester | Manchester | United Kingdom |
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A total of 57 subjects were enrolled in this study, of which 55 subjects were assigned to receive at least 1 eye drop while, 2 subjects were screen failures and/or not assigned. Of the total assigned subjects, 53 subjects completed the study and 2 subjects discontinued the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test/Control | Subjects randomized to this sequence received the Test eye drop during the first period and then received the Control eye drop during the second period. |
| FG001 | Control/Test | Subjects randomized to this sequence received the Control eye drop during the first period and then received the Test eye drop during the second period. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dispensed Subjects | All subjects dispensed at least one eye drop and 1 contact 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 |
| 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 | Ocular Comfort | Ocular comfort was measured using the visual analogue scale of 0 to 100. Where 0 is extremely uncomfortable and 100 is extremely comfortable. | All subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | Units on a scale | 1-Week Follow-up | eyes | eyes |
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Throughout the entire duration of the study. Approximately 3 week 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 | All subjects that wore the Test eye drop during either period 1 or period 2 during the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Meredith Bishop, OD, MS, FAAO | Johnson & Johnson Vision | 904-443-1396 | MBishop4@its.jnj.com |
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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 | Jan 3, 2018 | May 9, 2019 | Prot_SAP_000.pdf |
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| Control Eye Drops | Device | Systane® BALANCE eye drops |
|
| NOT COMPLETED |
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| 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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| Units | Counts |
|---|---|
| Participants |
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| eyes |
|
|
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| Secondary | Subjective Dryness Rating | Subjective dryness was assessed using Ocular Surface Disease Index (OSDI©) instrument. Dryness is evaluated on a scale of 0 to 100, where higher scores indicate more symptoms of dryness | All subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | Units on a Scale | 1-Week Follow-up |
|
|
|
|
| 0 |
| 55 |
| 0 |
| 55 |
| 0 |
| 55 |
| EG001 | Control | All subjects that wore the Control eye drop during either period 1 or period 2 during the study. | 0 | 55 | 0 | 55 | 0 | 55 |
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Mean difference was calculated as Test - Control |