Visual Acuity
Conditions
Brief summary
This is a single visit, randomized, double masked, bilateral, non-dispensing, 2×2 crossover study to assess visual acuity.
Interventions
Control Drops
DRUGInvestigational lipid eye drops
Test 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 of the following criteria to be enrolled in the study: 1. The subject must 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. Between 18 and 69 (inclusive) years of age at the time of screening. 4. Subjects must be habitual spherical soft contact lens wearers. 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. Currently pregnant or breast-feeding. 2. Diabetes. 3. Any ocular or systemic allergies or disease which may interfere with the clinical trial (at the discretion of the investigator). 4. Any systemic disease, autoimmune disease, or use of medication which may interfere with the clinical trial (at the discretion of the investigator). 5. Any infectious diseases (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV), by self-report. 6. History of any ocular or corneal surgery (e.g. RK, PRK, LASIK) 7. Participation in any pharmaceutical or medical device related clinical trial within 14 days prior to study enrollment. 8. History of binocular vision abnormality or strabismus. 9. Habitual wearers of rigid gas permeable lens within the past 3 months5. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g., SynergEyes, SoftPerm) within the past 6 months. 10. Current habitual use of Prescription Medication 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) 11. Employees of investigational clinic (investigator, coordinator, and technician etc) or family members of an employee of the clinical site by self-report. 12. Any Grade 3 or greater biomicroscopy findings (this includes, corneal edema, corneal staining, cornea vascularization, conjunctival injection, tarsal abnormalities, bulbar injection) on the FDA classification scale. 13. Any active ocular abnormalities/conditions that may interfere with the clinical trial (this includes, but not limited to, chalazia, recurrent styles, pterygium, infection, etc.). 14. Any corneal distortion due to previous rigid gas permeable lens wear, surgery or pathology.\\ In addition to the above criteria, patients with any allergy or sensitivity to ingredients that this product may contain should not participate in the study (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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity (logMAR) at 3 Minutes Post Instillation | 3 minutes post instillation | High contrast bright illumination monocular logMAR (Logarithm of the Minimum Angle of Resolution) visual acuity was assessed at distance (4 meters) using ETDRS Charts, near (40 cm) and intermediate (64 cm) using reduced Guillon-Poling charts. A value of 0.0 logMAR indicated a Snellen vision of 20/20. Lower logMAR visual acuity values indicate better vision. The average logMAR visual acuity for each treatment was reported. |
| Visual Acuity (logMAR) at 10 Minutes Post Instillation | 10 minutes post instillation | High contrast bright illumination monocular logMAR (Logarithm of the Minimum Angle of Resolution) visual acuity was assessed at distance (4 meters) using ETDRS Charts, near (40 cm) and intermediate (64 cm) using reduced Guillon-Poling charts. A value of 0.0 logMAR indicated a Snellen vision of 20/20. Lower logMAR visual acuity values indicate better vision. The average logMAR visual acuity for each treatment was reported. |
Countries
United States
Participant flow
Recruitment details
A total of 32 subjects were enrolled from two clinical sites in this study. Of those enrolled, a total of 31 (96.9%) subjects were randomly assigned among 2 unique eye drop sequences, study eye drops administered in both eyes for all subjects and were included in Safety Population; while, one (3.1%) subject was a screen failure and/or not assigned. Of the total assigned subjects, all 31 (96.9%) subjects completed the study.
Baseline characteristics
| Characteristic | Total |
|---|---|
| Age, Continuous | 34.9 Years STANDARD_DEVIATION 8.62 |
| Race/Ethnicity, Customized Asian | 3 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Race/Ethnicity, Customized White | 26 Participants |
| Region of Enrollment United States | 31 Participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 31 |
| other Total, other adverse events | 0 / 31 | 0 / 31 |
| serious Total, serious adverse events | 0 / 31 | 0 / 31 |
Outcome results
Primary
Visual Acuity (logMAR) at 10 Minutes Post Instillation
High contrast bright illumination monocular logMAR (Logarithm of the Minimum Angle of Resolution) visual acuity was assessed at distance (4 meters) using ETDRS Charts, near (40 cm) and intermediate (64 cm) using reduced Guillon-Poling charts. A value of 0.0 logMAR indicated a Snellen vision of 20/20. Lower logMAR visual acuity values indicate better vision. The average logMAR visual acuity for each treatment was reported.
Time frame: 10 minutes post instillation
Population: Subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Investigational Lipid Drop | Visual Acuity (logMAR) at 10 Minutes Post Instillation | 0.09 LogMAR | Standard Deviation 0.095 |
| Blink Tears | Visual Acuity (logMAR) at 10 Minutes Post Instillation | 0.09 LogMAR | Standard Deviation 0.087 |
Primary
Visual Acuity (logMAR) at 3 Minutes Post Instillation
High contrast bright illumination monocular logMAR (Logarithm of the Minimum Angle of Resolution) visual acuity was assessed at distance (4 meters) using ETDRS Charts, near (40 cm) and intermediate (64 cm) using reduced Guillon-Poling charts. A value of 0.0 logMAR indicated a Snellen vision of 20/20. Lower logMAR visual acuity values indicate better vision. The average logMAR visual acuity for each treatment was reported.
Time frame: 3 minutes post instillation
Population: Subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Investigational Lipid Drop | Visual Acuity (logMAR) at 3 Minutes Post Instillation | 0.09 LogMAR | Standard Deviation 0.082 |
| Blink Tears | Visual Acuity (logMAR) at 3 Minutes Post Instillation | 0.08 LogMAR | Standard Deviation 0.088 |