Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a double-masked, randomized, bilateral, 2-Arm parallel group study. Subjects are scheduled for 3 study visits (screening/baseline, 7-Day and 30-Day follow-up visits) over a period of one month.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Eye Drops | Experimental | Eligible subjects that are non-contact lens wearers will be randomized to the Test group throughout the duration of the study. |
|
| Control Eye Drops | Active Comparator | Eligible subjects that are non-contact lens wearers will be randomized to the Control group throughout the duration of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 9618X investigational lipid eye drops | Device | Test Eye Drops |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Ocular Comfort (30-Day) | Subjective overall ocular comfort was assessed at baseline, and at the 30-Day follow-up using a Visual Analogue Scale (VAS) ranging 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 report. | Baseline and 30-Day Follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Ocular Comfort (7-Day) | Subjective overall ocular comfort was assessed at baseline, and at the 7-Day follow-up using a Visual Analogue Scale (VAS) ranging from 0 (extremely uncomfortable) to 100 (extremely comfortable). The change from baseline ocular comfort score was calculated as 7-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 report. |
Not provided
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 achieve visual acuity of 20/30 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).
Self-reported symptoms of ocular dryness or irritation and/or the use of artificial tears in the last 3 months.
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 (Castor Oil, Polyoxyl 40 Hydrogenated Castor Oil, Sodium Chlorite, Boric Acid, Sodium Borate Decahydrate, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate, Polyethylene Glycol 400, Sodium Hyaluronate, Purified Water) should not participate in the study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Premier Vision | Amarillo | Texas | 79119 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39379885 | Derived | Donnenfeld E, Coats J, Barbour K, Ryan R, Joshi NR, Periman LM. Efficacy and safety of a lipid-containing artificial tear compared with a non-lipid containing tear: a randomized clinical trial. BMC Ophthalmol. 2024 Oct 8;24(1):442. doi: 10.1186/s12886-024-03688-z. |
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
A total of 161 subjects were enrolled in this study. Of those enrolled, 158 subjects were dispensed a test article while 3 subjects failed to meet all eligibility criteria. Of those dispensed, 155 subjects completed the study while 3 subjects were discontinued.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Test (Investigational Lipid Eye Drop) | Subjects randomized to the Test eye drops throughout the entire duration of the study. |
| FG001 | Control (Blink Tears Eye Drops) | Subjects that instilled the Control eye drops throughout the study |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All subjects dispensed a study lens
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Test (Investigational Lipid Eye Drop) | Subjects randomized to the Test eye drops throughout the entire duration of the study. |
| BG001 | Control (Blink Tears Eye Drops) | Subjects that instilled the Control eye drops throughout the study |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Change From Baseline Ocular Comfort (30-Day) | Subjective overall ocular comfort was assessed at baseline, and at the 30-Day follow-up using a Visual Analogue Scale (VAS) ranging 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 report. | All subjects who had successfully completed all visits and did not substantially deviate from the protocol. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and 30-Day Follow-up |
|
Throught the entire duration of the study. Approximately 30 Days per subject.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test (Investigational Lipid Eye Drop) | Subjects randomized to the Test eye drops throughout the entire duration of the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Corneal Edema Due to Trauma | Injury, poisoning and procedural complications | Systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Meredith Bishop, OD, MS, FAAO - Sr. Principal Research Optometrist | Johnson & Johnson Vision | 1-800-843-2020 | MBishop4@its.jnj.com |
Not provided
| 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 13, 2019 | Sep 15, 2022 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Blink® Tears |
| Device |
Control Eye Drops |
|
| Baseline and 7-Day Follow-up |
| Number of Subject Eyes That Reported Ocular Symptoms | Subjects were reported whether they experienced any ocular symptoms, problems or complaints (yes/no) by eye. Ocular symptoms were assessed for each subject eye at all study visits (scheduled and unscheduled). The number of eyes that experience ocular symptoms or complaints was reported for the 7- and 30-Day follow-up. | 7-Day Follow-up and 30-Day Follow-up |
| Number of Subject Eyes That Experience Grade 2 or Higher Corneal Staining | Corneal staining was analyzed using the FDA grading scale (ie, Grade 0 = None, Grade 1 = Trace, Grade 2 = Mild, Grade 3 = Moderate and Grade 4 = Severe). These responses were categorized into a binary outcome as 1 if any Grade 2 or higher corneal staining was observed or otherwise 0 is recorded. Subjects with multiple events were counted only once for the analysis purpose. | 7-Day Follow-up and 30-Day Follow-up |
| Change From Baseline Ocular Vision (7-Day) | Subjective overall ocular vision was assessed at baseline, dispensing and 7-Day follow-up using a Visual Analogue Scale (VAS) from 0 (extremely uncomfortable) to 100 (extremely comfortable). The change from baseline ocular vision score was calculated as 7-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. | Baseline and 7 Day-Day Follow-up |
| Change From Baseline Ocular Vision (30-Day) | Subjective overall ocular vision was assessed at baseline, dispensing and 30 Day follow-up using a Visual Analogue Scale (VAS) from 0 (extremely uncomfortable) to 100 (extremely comfortable). The change from baseline ocular 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. | Baseline and 30 Day Follow-up |
| Scheduling Issues |
|
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
| OG001 | Control (Blink Tears Eye Drops) | Subjects that instilled the Control eye drops throughout the study |
|
|
|
| Secondary | Change From Baseline Ocular Comfort (7-Day) | Subjective overall ocular comfort was assessed at baseline, and at the 7-Day follow-up using a Visual Analogue Scale (VAS) ranging from 0 (extremely uncomfortable) to 100 (extremely comfortable). The change from baseline ocular comfort score was calculated as 7-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 report. | All subjects who had successfully completed all visits and did not substantially deviate from the protocol. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and 7-Day Follow-up |
|
|
|
|
| Secondary | Number of Subject Eyes That Reported Ocular Symptoms | Subjects were reported whether they experienced any ocular symptoms, problems or complaints (yes/no) by eye. Ocular symptoms were assessed for each subject eye at all study visits (scheduled and unscheduled). The number of eyes that experience ocular symptoms or complaints was reported for the 7- and 30-Day follow-up. | All subjects/eyes who were that administered any test article excluding subjects who dropped out prior to administering any test article. | Posted | Number | Eyes | 7-Day Follow-up and 30-Day Follow-up | Eyes | Eyes |
|
|
|
|
| Secondary | Number of Subject Eyes That Experience Grade 2 or Higher Corneal Staining | Corneal staining was analyzed using the FDA grading scale (ie, Grade 0 = None, Grade 1 = Trace, Grade 2 = Mild, Grade 3 = Moderate and Grade 4 = Severe). These responses were categorized into a binary outcome as 1 if any Grade 2 or higher corneal staining was observed or otherwise 0 is recorded. Subjects with multiple events were counted only once for the analysis purpose. | All subjects who were administered any test article excluding subjects who dropped out prior to administering any test article. | Posted | Number | Eyes | 7-Day Follow-up and 30-Day Follow-up | Eyes | Eyes |
|
|
|
|
| Secondary | Change From Baseline Ocular Vision (7-Day) | Subjective overall ocular vision was assessed at baseline, dispensing and 7-Day follow-up using a Visual Analogue Scale (VAS) from 0 (extremely uncomfortable) to 100 (extremely comfortable). The change from baseline ocular vision score was calculated as 7-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 subjects who had successfully completed all visits and did not substantially deviate from the protocol. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and 7 Day-Day Follow-up |
|
|
|
|
| Secondary | Change From Baseline Ocular Vision (30-Day) | Subjective overall ocular vision was assessed at baseline, dispensing and 30 Day follow-up using a Visual Analogue Scale (VAS) from 0 (extremely uncomfortable) to 100 (extremely comfortable). The change from baseline ocular 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 subjects who had successfully completed all visits and did not substantially deviate from the protocol. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and 30 Day Follow-up |
|
|
|
|
| 0 |
| 77 |
| 1 |
| 77 |
| 0 |
| 77 |
| EG001 | Control (Blink Tears Eye Drops) | Subjects that instilled the Control eye drops throughout the study | 0 | 81 | 1 | 81 | 0 | 81 |
| Pancreatitis | Metabolism and nutrition disorders | Systematic Assessment |
|
Not provided
| Generalized linear Mixed Model Analysis |
| Odds Ratio (OR) |
| 1.160 |
| 2-Sided |
| 95 |
| 0.610 |
| 2.203 |
Odds ratio was calculated as Test over Control. No difference was concluded if 1 fall within the 95% confidence interval for the odds ratio. |
| Other |