Visual Acuity, Slit Lamp Biomicroscopy (Corneal Staining Assessment)
Conditions
Brief summary
This is a multi-site, randomized, double-masked, contralateral, 2 treatment x 2 period crossover, dispensing, five-visit study to gain clinical insights of the study lenses and solutions.
Interventions
DEVICEOpti-Free : RevitaLens / Clear Care : RevitaLens
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
DEVICEOpti-Free : RevitaLens / RevitaLens : Clear Care
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
DEVICEClear Care : RevitaLens/ Opti-Free : RevitaLens
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
DEVICEClear Care : RevitaLens / RevitaLens : Opti-Free
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
DEVICERevitaLens : Clear Care/ Opti-Free : RevitaLens
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
DEVICERevitaLens : Clear Care / RevitaLens : Opti-Free
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
DEVICERevitaLens : Opti-Free / Clear Care : RevitaLens
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
DEVICERevitaLens : Opit-Free / RevitaLens : Clear Care
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
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. Subjects must be 18-69 years of age (inclusive). 2. Subjects must be habitual disposable hydrogel or silicone hydrogel (1-day, 2-week, or monthly replacement schedule) soft lens wearer in both eyes. Habitual is defined as at least one (1) month of contact lens wear where the lenses are worn for a minimum of six (6) hours per day and a minimum of five (5) days per week. 3. Subjects must have best corrected visual acuity of 20/25 (Snellen or equivalent) or better in each eye. 4. The subject's refractive sphere (vertexed) must be between -1.00 and -6.00 D in each eye. 5. The subject's refractive cylinder must be less than or equal to -1.00 D in each eye. 6. The subject must have normal eyes (i.e., no ocular medications or infections of any type). 7. Subjects must possess a functional/usable pair of spectacles and bring them to the visit (only if applicable - to the investigators discretion). 8. Subjects must read, understand, and sign the Statement of Informed Consent. 9. 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 contact lens wear (at the discretion of the investigator). 4. Any systemic disease, autoimmune disease, or use of medication which may interfere with contact lens wear (at the discretion of the investigator). 5. Any infectious diseases (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (eg, HIV), by self-report. 6. Current habitual use of Restasis, Xiidra, ocular steroids, or any medication (RX or OTC) that may interfere with contact lens wear (at the discretion of the investigator). 7. Grade 2 or greater corneal staining or conjunctival injection on the FDA scale. 8. Clinically significant (Grade 3 or greater on the FDA scale) corneal edema, corneal vascularization, or any other abnormalities of the cornea (excluding corneal staining) which would contraindicate contact lens wear. 9. Clinically significant (Grade 3 or greater on the FDA scale) tarsal abnormalities which might interfere with contact lens wear. 10. Any active ocular abnormalities/conditions that may interfere with contact lens wear (at the discretion of the investigator). 11. Any corneal distortion due to previous rigid gas permeable lens wear, surgery or pathology. 12. History of any ocular or corneal surgery (eg, RK, PRK, LASIK). 13. Habitual contact lens wear modality as extended wear. 14. Participation in any pharmaceutical or medical device related clinical trial within 7 days prior to study enrollment. 15. History of binocular vision abnormality or strabismus. 16. Habitual wearers of rigid gas permeable lens within the past 3 months. 17. Employees of investigational clinic (investigator, coordinator, and technician etc.) or family members of employees of the investigational clinic by self-report
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject Comfort | Up to 2-Hours Post Lens Fitting | Subjective assessment of initial comfort was conducted using Visual Analogue Scale (VAS) of comfort. VAS of comfort consists of a vertical line which represents continuous scale from 0 (extremely uncomfortable) to 100 (extremely comfortable). VAS comfort was measured at 1-min, 5-min, 45-min, and 2-hours post-fit. The average comfort score for each solution was reported. This is a contralateral crossover, subject used the revitalens solution in one eye throughout the entire study therefore there are twice as many observations for revitalens compared to the other solutions. |
Countries
United States
Participant flow
Recruitment details
A total of 130 subjects were enrolled into this study. Of those enrolled, 113 subjects were assigned and dispensed a study lens while, 15 subjects were screen failures and 2 subjects were assigned but not administered the Test article. Of those dispensed, 106 subjects completed the study while, 7 subjects were discontinued.
Pre-assignment details
Of those that completed the study, 78 subjects completed without a major protocol deviation impacting a primary endpoint.
Participants by arm
| Arm | Count |
|---|---|
| Etafilcon A Subjects that wore the etafilcon A lens during the entire study. | 37 |
| Senofilcon A Subjects that wore the senofilcon A lens during the entire study. | 38 |
| Senofilcon C Subjects that wore the senofilcon C lens during the entire study. | 38 |
| Total | 113 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Period 1 | Grade 2 Conjunctivitis | 0 | 0 | 1 | 0 | 0 | 0 |
| Period 1 | Lost to Follow-up | 0 | 0 | 0 | 1 | 0 | 0 |
| Period 1 | Test Lens Damage | 0 | 2 | 0 | 0 | 0 | 0 |
| Period 1 | Withdrawal by Subject | 0 | 0 | 2 | 0 | 0 | 0 |
| Period 2 | Lens Handling Difficulties | 0 | 0 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Etafilcon A | Senofilcon A | Senofilcon C | Total |
|---|---|---|---|---|
| Age, Continuous | 28.1 Years STANDARD_DEVIATION 9.41 | 27.7 Years STANDARD_DEVIATION 7.82 | 29.1 Years STANDARD_DEVIATION 10.52 | 28.3 Years STANDARD_DEVIATION 9.25 |
| Race/Ethnicity, Customized Asian | 11 Participants | 10 Participants | 12 Participants | 33 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 5 Participants | 2 Participants | 8 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Island | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 3 Participants | 0 Participants | 5 Participants |
| Race/Ethnicity, Customized White | 22 Participants | 20 Participants | 24 Participants | 66 Participants |
| Region of Enrollment United States | 37 Participants | 38 Participants | 38 Participants | 113 Participants |
| Sex: Female, Male Female | 20 Participants | 30 Participants | 27 Participants | 77 Participants |
| Sex: Female, Male Male | 17 Participants | 8 Participants | 11 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 37 | 0 / 37 | 0 / 37 | 0 / 38 | 0 / 38 | 0 / 38 | 0 / 38 | 0 / 38 | 0 / 38 |
| other Total, other adverse events | 0 / 37 | 0 / 37 | 0 / 37 | 0 / 38 | 0 / 38 | 0 / 38 | 0 / 38 | 0 / 38 | 0 / 38 |
| serious Total, serious adverse events | 0 / 37 | 0 / 37 | 0 / 37 | 0 / 38 | 0 / 38 | 0 / 38 | 0 / 38 | 0 / 38 | 0 / 38 |
Outcome results
Primary
Subject Comfort
Subjective assessment of initial comfort was conducted using Visual Analogue Scale (VAS) of comfort. VAS of comfort consists of a vertical line which represents continuous scale from 0 (extremely uncomfortable) to 100 (extremely comfortable). VAS comfort was measured at 1-min, 5-min, 45-min, and 2-hours post-fit. The average comfort score for each solution was reported. This is a contralateral crossover, subject used the revitalens solution in one eye throughout the entire study therefore there are twice as many observations for revitalens compared to the other solutions.
Time frame: Up to 2-Hours Post Lens Fitting
Population: All subjects who successfully completed all study visits without a major protocol deviation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Revita- Lens | Subject Comfort | 1-Minute Follow-up | 92.4 Units on a scale | Standard Deviation 11.74 |
| Revita- Lens | Subject Comfort | 2-Hour Follow-up | 94.7 Units on a scale | Standard Deviation 7.06 |
| Revita- Lens | Subject Comfort | 45 Minute Follow-up | 93.5 Units on a scale | Standard Deviation 9.48 |
| Revita- Lens | Subject Comfort | 5-Minute Follow-up | 63.0 Units on a scale | Standard Deviation 10.17 |
| Clear Care | Subject Comfort | 45 Minute Follow-up | 93.7 Units on a scale | Standard Deviation 8.44 |
| Clear Care | Subject Comfort | 5-Minute Follow-up | 93.4 Units on a scale | Standard Deviation 8.9 |
| Clear Care | Subject Comfort | 2-Hour Follow-up | 94.6 Units on a scale | Standard Deviation 7.32 |
| Clear Care | Subject Comfort | 1-Minute Follow-up | 92.4 Units on a scale | Standard Deviation 10.52 |
| Opti-Free | Subject Comfort | 2-Hour Follow-up | 94.3 Units on a scale | Standard Deviation 7.39 |
| Opti-Free | Subject Comfort | 1-Minute Follow-up | 92.0 Units on a scale | Standard Deviation 10.58 |
| Opti-Free | Subject Comfort | 5-Minute Follow-up | 92.3 Units on a scale | Standard Deviation 9.81 |
| Opti-Free | Subject Comfort | 45 Minute Follow-up | 93.5 Units on a scale | Standard Deviation 7.96 |
Comparison: 1-Minute Follow-up Analysis95% CI: [-6.4, 2.3]bayesian multivariate hierarachical
Comparison: 5-minute Follow-up Analysis95% CI: [-6.8, 1.7]Bayesian Multivariate Hierarchical Model
Comparison: 45-Minute Follolw-up Analysis95% CI: [-6.9, 1.5]Bayesian multivariate hierarchical model
Comparison: 2-Hour Follow-up Analysis95% CI: [-6.5, 1.4]Bayesian Multivariate Heirarchical Model
Comparison: 1-Minute Follow-up Analysis95% CI: [-5.8, 3.1]Bayesian Multivariate Heirarchical Model
Comparison: 5-Minute Follow-up Analysis95% CI: [-5, 3.6]Bayesian Multivariate Heirarchical Model
Comparison: 45-Minute Follow-up Analysis95% CI: [-6.4, 2.3]Bayesian Multivariate Hierarchical Model
Comparison: 2-Hour Follow-up Analysis95% CI: [-5.8, 2.5]Bayesian Mutlivariate Hiearachical Model