Visual Acuity
Conditions
Brief summary
This will be a single-visit, multi-site, randomized, single-masked, bilateral, active-controlled, non-dispensing, 2X2 crossover study.
Interventions
DRUGBlink® Tears eye drops in a multidose bottle
Control
DRUGPreservative-free investigational lubricating eye drops in a Novelia® eyedropper
Test
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
Yes
Inclusion criteria
* Potential subjects must satisfy all of the following criteria to be enrolled in the study: The subject must: 1. Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. 2. Appear able and willing to adhere to the instructions set forth in this clinical protocol. 3. Be between 18 and 69 (inclusive) years of age at the time of screening. 4. By self-report, habitually wear soft spherical contact lenses in both eyes in a daily reusable or daily disposable wear modality (i.e., not extended wear modality). Habitual wear is defined as a minimum of 6 hours per day, for a minimum of 2 days per week during the last 30 days. 5. Subjects must achieve visual acuity of 20/30 or better in each eye, with their habitual contact lenses.
Exclusion criteria
* Potential subjects who meet any of the following criteria will be excluded from participating in the study: The subject must not: 1. Be currently pregnant or lactating. 2. Be diabetic. 3. Be currently using any ocular medications or have any ocular infection of any type which may interfere with the clinical trial (at the investigator's discretion). 4. By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that might contraindicate or interfere with the clinical trial, or otherwise compromise study endpoints, including infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus \[HIV\]), autoimmune disease (e.g., rheumatoid arthritis, Sjögren's syndrome), or history of serious mental illness or seizures. See section 9.1 for additional details regarding excluded systemic medications. 5. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g., SynergEyes, SoftPerm) within the past 3 months. 6. Have participated in any pharmaceutical or medical device related clinical trial within 14 days prior to study enrollment. 7. Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site. 8. Be a current habitual user of prescription medication to treat dry eye and ocular discomfort, ocular steroids, or any medication (RX or OTC) except artificial tears, that would interfere with the clinical study (at the discretion of the investigator). 9. Have any known allergy or sensitivity to ingredients that the investigational product may contain (e.g., Sodium Chlorite, Boric Acid, Sodium Borate Decahydrate, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate, Polyethylene Glycol 400, Sodium Hyaluronate and Purified Water). 10. Have clinically significant (grade 3 or higher on the FDA grading scale) slit lamp findings (e.g., corneal edema, neovascularization or staining, tarsal abnormalities, or bulbar injection) or other corneal or ocular disease or abnormalities that contraindicate participation or may otherwise compromise study endpoints (including entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, moderate or above corneal distortion, herpetic keratitis). 11. Have a history of strabismus or amblyopia. 12. Have had or have planned (within the study period) any ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, iridotomy, cataract removal, retinal laser photocoagulation, etc.). 13. Have any significant corneal distortion due to previous contact lens wear, surgery, or pathology (At the discretion of the investigator).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Monocular logMAR Visual Acuity | 10 Minutes Post Eye Drop Administration | Monocular visual acuity was measured at distance (4meter) using a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast lighting conditions. VA was assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. Letter-by-letter results calculated the visual acuity score for each chart read. LogMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20. |
Countries
United States
Participant flow
Recruitment details
A total of 46 subjects were enrolled in this study. Of those enrolled, 44 subjects were dispensed at least one study lens, while 2 subjects failed to meet all eligibility criteria. All 44 dispensed subjects completed the study. 1-2 drops of Test and Control eye drops were administered to both eyes for every subject. This is a single visit study with 90-minute washout between period 1 and 2.
Participants by arm
| Arm | Count |
|---|---|
| Dispensed Subjects All subjects dispensed at least one study lens | 44 |
| Total | 44 |
Baseline characteristics
| Characteristic | Dispensed Subjects |
|---|---|
| Age, Continuous | 33.7 years STANDARD_DEVIATION 8.19 |
| Race/Ethnicity, Customized Asian | 5 Participants |
| Race/Ethnicity, Customized Black or African American | 8 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race/Ethnicity, Customized White | 30 Participants |
| Region of Enrollment United States | 44 Participants |
| Sex: Female, Male Female | 36 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 44 |
| other Total, other adverse events | 0 / 44 | 0 / 44 |
| serious Total, serious adverse events | 0 / 44 | 0 / 44 |
Outcome results
Primary
Monocular logMAR Visual Acuity
Monocular visual acuity was measured at distance (4meter) using a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast lighting conditions. VA was assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. Letter-by-letter results calculated the visual acuity score for each chart read. LogMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.
Time frame: 10 Minutes Post Eye Drop Administration
Population: All subjects who successfully complete all visits and do not substantially deviate from the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | Monocular logMAR Visual Acuity | 0.033 logMAR | Standard Deviation 0.1131 |
| Control | Monocular logMAR Visual Acuity | 0.038 logMAR | Standard Deviation 0.1206 |
Comparison: The sample size of 38 was calculated to provide at least 90% statistical power to test Non-inferiority of the Test lens compared to the Control lens using a paired t-test with a two-sided type I error rate of 5%.95% CI: [-0.025, 0.014]Linear Mixed Model