Visual Acuity
Conditions
Brief summary
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.
Interventions
DEVICEBlink® Tears
Control Eye Drops
DEVICE9618X investigational lipid eye drops
Test Eye Drops
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
Yes
Inclusion criteria
* Potential subjects must satisfy all the following criteria to be enrolled in the study: 1. Subjects must be at least 18 years of age and no more than 69 years of age (inclusive). 2. Subjects must be non-contact lens wearers. 3. Subjects must achieve visual acuity of 20/30 or better in each eye, either unaided or best corrected. 4. Subjects must possess a functional/usable pair of spectacles and bring them to every visit (only if applicable - to the investigators discretion). 5. Self-reported symptoms of ocular dryness or irritation and/or the use of artificial tears in the last 3 months. 6. Subjects must read, understand, and sign the Statement of Informed Consent. 7. 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: 1. Currently pregnant or breast-feeding. 2. Diabetes. 3. Any ocular or systemic allergies or disease which may interfere with the clinical trial (at the investigator's discretion). 4. Any systemic disease, autoimmune disease, or use of medication which may interfere with the clinical trial (at the investigator's discretion). 5. Any infectious diseases (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV), by self-report. 6. Any Grade 3 or greater biomicroscopy findings (this includes, corneal edema, corneal staining, corneal vascularization, conjunctival injection, tarsal abnormalities, bulbar injection) on the FDA scale. 7. Any active ocular abnormalities/conditions that may interfere with the clinical trial (this includes, but not limited to, chalazia, recurrent styles, pterygium, infection, etc.). 8. Any corneal distortion due to previous rigid gas permeable lens wear, surgery or pathology. 9. History of any ocular or corneal surgery (e.g. RK, PRK, LASIK). 10. Participation in any pharmaceutical or medical device related clinical trial within 30 days prior to study enrollment. 11. History of binocular vision abnormality or strabismus. 12. Habitual wearers of soft contact lenses in the past 1 month or rigid gas permeable lens within the past 3 months. 13. Current habitual use of Prescription Medicines to treat dry eye or ocular discomfort, ocular steroids, or any medication (RX or OTC) that would interfere with the clinical study (at the discretion of the investigator). 14. Employees of investigational clinic (investigator, coordinator, and technician, etc.) or family member of an employee of the clinical site by self-report. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Ocular Comfort (30-Day) | Baseline and 30-Day Follow-up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Ocular Comfort (7-Day) | Baseline and 7-Day Follow-up | 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. |
| Number of Subject Eyes That Reported Ocular Symptoms | 7-Day Follow-up and 30-Day Follow-up | 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. |
| Number of Subject Eyes That Experience Grade 2 or Higher Corneal Staining | 7-Day Follow-up and 30-Day Follow-up | 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. |
| Change From Baseline Ocular Vision (7-Day) | Baseline and 7 Day-Day Follow-up | 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. |
| Change From Baseline Ocular Vision (30-Day) | Baseline and 30 Day Follow-up | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Test (Investigational Lipid Eye Drop) Subjects randomized to the Test eye drops throughout the entire duration of the study. | 77 |
| Control (Blink Tears Eye Drops) Subjects that instilled the Control eye drops throughout the study | 81 |
| Total | 158 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Scheduling Issues | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Test (Investigational Lipid Eye Drop) | Total | Control (Blink Tears Eye Drops) |
|---|---|---|---|
| Age, Continuous | 46.8 Years STANDARD_DEVIATION 14.51 | 47.8 Years STANDARD_DEVIATION 14.14 | 48.8 Years STANDARD_DEVIATION 13.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 24 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 63 Participants | 131 Participants | 68 Participants |
| Region of Enrollment United States | 77 Participants | 158 Participants | 81 Participants |
| Sex: Female, Male Female | 58 Participants | 114 Participants | 56 Participants |
| Sex: Female, Male Male | 19 Participants | 44 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 77 | 0 / 81 |
| other Total, other adverse events | 0 / 77 | 0 / 81 |
| serious Total, serious adverse events | 1 / 77 | 1 / 81 |
Outcome results
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.
Time frame: Baseline and 30-Day Follow-up
Population: All subjects who had successfully completed all visits and did not substantially deviate from the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test (Investigational Lipid Eye Drops) | Change From Baseline Ocular Comfort (30-Day) | 21.4 Units on a scale | Standard Deviation 24.51 |
| Control (Blink Tears Eye Drops) | Change From Baseline Ocular Comfort (30-Day) | 10.0 Units on a scale | Standard Deviation 26.01 |
95% CI: [2.6, 20.1]Linear Mixed Model Analysis
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.
Time frame: Baseline and 7-Day Follow-up
Population: All subjects who had successfully completed all visits and did not substantially deviate from the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test (Investigational Lipid Eye Drops) | Change From Baseline Ocular Comfort (7-Day) | 14.3 Units on a scale | Standard Deviation 24.02 |
| Control (Blink Tears Eye Drops) | Change From Baseline Ocular Comfort (7-Day) | 11.7 Units on a scale | Standard Deviation 21.23 |
95% CI: [-5.3, 10.4]Linear Mixed Model Analysis
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.
Time frame: Baseline and 30 Day Follow-up
Population: All subjects who had successfully completed all visits and did not substantially deviate from the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test (Investigational Lipid Eye Drops) | Change From Baseline Ocular Vision (30-Day) | 14.2 Units on a scale | Standard Deviation 22.52 |
| Control (Blink Tears Eye Drops) | Change From Baseline Ocular Vision (30-Day) | 4.9 Units on a scale | Standard Deviation 21.55 |
95% CI: [1.7, 17]Linear Mixed Model Analysis
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.
Time frame: Baseline and 7 Day-Day Follow-up
Population: All subjects who had successfully completed all visits and did not substantially deviate from the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test (Investigational Lipid Eye Drops) | Change From Baseline Ocular Vision (7-Day) | 13.3 Units on a scale | Standard Deviation 23.23 |
| Control (Blink Tears Eye Drops) | Change From Baseline Ocular Vision (7-Day) | 5.2 Units on a scale | Standard Deviation 19.23 |
95% CI: [0.7, 15.4]Linear Mixed Model Analysis
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.
Time frame: 7-Day Follow-up and 30-Day Follow-up
Population: All subjects who were administered any test article excluding subjects who dropped out prior to administering any test article.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Test (Investigational Lipid Eye Drops) | Number of Subject Eyes That Experience Grade 2 or Higher Corneal Staining | 7-Day Follow-up | 1 Eyes |
| Test (Investigational Lipid Eye Drops) | Number of Subject Eyes That Experience Grade 2 or Higher Corneal Staining | 30-Day Follow-up | 2 Eyes |
| Control (Blink Tears Eye Drops) | Number of Subject Eyes That Experience Grade 2 or Higher Corneal Staining | 7-Day Follow-up | 2 Eyes |
| Control (Blink Tears Eye Drops) | Number of Subject Eyes That Experience Grade 2 or Higher Corneal Staining | 30-Day Follow-up | 0 Eyes |
95% CI: [0.178, 19.616]Fisher Exact
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.
Time frame: 7-Day Follow-up and 30-Day Follow-up
Population: All subjects/eyes who were that administered any test article excluding subjects who dropped out prior to administering any test article.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Test (Investigational Lipid Eye Drops) | Number of Subject Eyes That Reported Ocular Symptoms | 7-Day Follow-up | 33 Eyes |
| Test (Investigational Lipid Eye Drops) | Number of Subject Eyes That Reported Ocular Symptoms | 30-Day Follow-up | 21 Eyes |
| Control (Blink Tears Eye Drops) | Number of Subject Eyes That Reported Ocular Symptoms | 7-Day Follow-up | 37 Eyes |
| Control (Blink Tears Eye Drops) | Number of Subject Eyes That Reported Ocular Symptoms | 30-Day Follow-up | 21 Eyes |
95% CI: [0.528, 1.77]Generalized linear Mixed Model Analysis
Comparison: 30-Day follow-up95% CI: [0.61, 2.203]Generalized linear Mixed Model Analysis