Ocular Physiology
Conditions
Brief summary
This will be a single-visit, randomized, double-masked, bilateral wear, non-dispensing, 2-sequence × 2-period crossover study to evaluate subject reported ocular symptoms.
Interventions
DEVICEAcuvue Oasys 1 Day for Astigmatism with Legacy lidstock
CONTROL
DEVICEAcuvue Oasys 1 Day for Astigmatism with Amcor laminated lidstock
TEST
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 39 Years
Healthy volunteers
Yes
Inclusion criteria
* Potential subjects must satisfy all of the following criteria to be enrolled in the study: 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 39 years of age (inclusive) at the time of screening. 4. Habitually wear soft contact lenses (either sphere or toric) 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 past four weeks. 5. Possess a wearable pair of spectacles that provide correction for distance vision. 6. Have the spherical component of their vertex-corrected distance refraction within the range +4.00 to -9.00 DS (inclusive) in both eyes. 7. Have the magnitude of the cylindrical component of their vertex-corrected distance refraction below 3.00 DC (inclusive) in both eyes. 8. Have best corrected monocular distance VA of 20/30 or better in each eye.
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 an ocular infection of any type. 4. Have any ocular or systemic allergies, disease, infection, or use of medication that might contraindicate or interfere with contact lens wear or otherwise compromise study endpoints, including infectious diseases (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus \[HIV\]), or history of serious mental illness or seizures. See section 9.1 for additional details regarding systemic medications. 5. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g., SynergEyes, SoftPerm) within the past 6 months. 6. Be currently wearing monovision or multifocal contact lenses or be currently wearing lenses in an extended wear modality. 7. Have a history of strabismus or amblyopia. 8. Be an employee (e.g., Investigator, Coordinator, Technician) or family member of an employee of investigational clinic. 9. Have participated in a contact lens or lens care product clinical trial within 7 days prior to study enrollment. 10. Have clinically significant (Grade 3 or 4 on the FDA classification 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 may contraindicate contact lens wear or 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 fluctuations in vision due to clinically significant dry eye or other ocular conditions. 12. Have had or have planned (within the study period) ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Eyes With Moderate or Severe Subject-Reported Ocular Symptoms | Up to 1-Hour Follow-Up | Ocular symptoms were assessed using open-ended question. Investigators asked each subject if they experienced any eye symptoms or problems with lens wear when wearing the study lenses. If responded Yes, then subject characterized each symptom to the following scale for each eye: 0 = Not Applicable or Not Recorded, 1 = Mild and results in little or no interference with lens wear, 2 = Moderate AND/OR occasionally interferes with lens wear, and 3 = Severe AND/OR frequently interferes with lens wear. Investigators classified each subject reported symptom into these categories: Burning/stinging, Itchiness/Scratchiness, Dryness, Lens Awareness, Grittiness/Foreign Body Sensation, Redness, Irritation/Discomfort, Cloudy/Blurry/Hazy, Variable Vision, and Other. The data was dichotomized across all symptoms, where Y=1 if any moderate or severe ocular symptoms were reported and Y=0 otherwise. The proportion of eyes with any moderate or severe ocular symptoms was reported for each lens. |
Countries
United States
Participant flow
Recruitment details
A total of 31 subjects were enrolled in this study. Of those enrolled, 30 subjects were dispensed at least one study lens, while 1 subject failed to meet all eligibility criteria. Of those dispensed, all 30 subjects completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Dispensed Subjects All subjects dispensed a study lens. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Dispensed Subjects |
|---|---|
| Age, Continuous | 29.5 Years STANDARD_DEVIATION 6.43 |
| Race/Ethnicity, Customized Asian | 5 Participants |
| Race/Ethnicity, Customized Black or African American | 3 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race/Ethnicity, Customized White | 21 Participants |
| Region of Enrollment United States | 30 Participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Proportion of Eyes With Moderate or Severe Subject-Reported Ocular Symptoms
Ocular symptoms were assessed using open-ended question. Investigators asked each subject if they experienced any eye symptoms or problems with lens wear when wearing the study lenses. If responded Yes, then subject characterized each symptom to the following scale for each eye: 0 = Not Applicable or Not Recorded, 1 = Mild and results in little or no interference with lens wear, 2 = Moderate AND/OR occasionally interferes with lens wear, and 3 = Severe AND/OR frequently interferes with lens wear. Investigators classified each subject reported symptom into these categories: Burning/stinging, Itchiness/Scratchiness, Dryness, Lens Awareness, Grittiness/Foreign Body Sensation, Redness, Irritation/Discomfort, Cloudy/Blurry/Hazy, Variable Vision, and Other. The data was dichotomized across all symptoms, where Y=1 if any moderate or severe ocular symptoms were reported and Y=0 otherwise. The proportion of eyes with any moderate or severe ocular symptoms was reported for each lens.
Time frame: Up to 1-Hour Follow-Up
Population: All subjects that were dispensed at least one study lens.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Test | Proportion of Eyes With Moderate or Severe Subject-Reported Ocular Symptoms | 15-Minute Follow-up | 0 Proportion of eyes |
| Test | Proportion of Eyes With Moderate or Severe Subject-Reported Ocular Symptoms | 1-Hour Follow-up | 0 Proportion of eyes |
| Control | Proportion of Eyes With Moderate or Severe Subject-Reported Ocular Symptoms | 15-Minute Follow-up | 0 Proportion of eyes |
| Control | Proportion of Eyes With Moderate or Severe Subject-Reported Ocular Symptoms | 1-Hour Follow-up | 0 Proportion of eyes |