Visual Acuity
Conditions
Brief summary
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.
Interventions
DEVICETest Eye Drops
blink® intensive TRIPLE ACTION 3 in 1 eye drops
DEVICEControl Eye Drops
Systane® BALANCE eye drops
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
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 have a DEQ-5 score of \>6 at either Visit 0 (pre-screen) and/or Visit 1 (screening). 4. Subjects must achieve visual acuity of 20/30 (equivalent to 0.18 logMAR) or better in each eye, either unaided or best corrected. 5. Subjects must possess a functional/usable pair of spectacles and bring them to every visit (only if applicable - to the investigators discretion). 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 14 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 Only Medicines (POM) 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 (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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Comfort | 1-Week Follow-up | Ocular comfort was measured using the visual analogue scale of 0 to 100. Where 0 is extremely uncomfortable and 100 is extremely comfortable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Dryness Rating | 1-Week Follow-up | 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 |
Countries
United Kingdom
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Dispensed Subjects All subjects dispensed at least one eye drop and 1 contact lens | 55 |
| Total | 55 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 | Sponsor decision due to study timeline | 1 | 0 |
| Period 1 | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Dispensed Subjects |
|---|---|
| Age, Continuous | 26.76 Years STANDARD_DEVIATION 11.273 |
| Race/Ethnicity, Customized Asian | 13 Participants |
| Race/Ethnicity, Customized Black Or African American | 4 Participants |
| Race/Ethnicity, Customized Other | 4 Participants |
| Race/Ethnicity, Customized White | 34 Participants |
| Region of Enrollment United Kingdom | 55 Participants |
| Sex: Female, Male Female | 37 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 55 |
| other Total, other adverse events | 0 / 55 | 0 / 55 |
| serious Total, serious adverse events | 0 / 55 | 0 / 55 |
Outcome results
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.
Time frame: 1-Week Follow-up
Population: All subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | Ocular Comfort | 81.96 Units on a scale | Standard Deviation 12.407 |
| Control | Ocular Comfort | 82.49 Units on a scale | Standard Deviation 15.238 |
95% CI: [-2.35, 2.59]Multivariate Bayesian Model
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
Time frame: 1-Week Follow-up
Population: All subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | Subjective Dryness Rating | 25.68 Units on a Scale | Standard Deviation 10.162 |
| Control | Subjective Dryness Rating | 24.69 Units on a Scale | Standard Deviation 10.609 |
Comparison: This was a pilot study and the sample size was not based on any empirical power calculation.95% CI: [-0.4, 3.37]Multivariate Bayesian Analysis