Visual Acuity
Conditions
Brief summary
In vitro studies show that some hydrogel materials uptake more lysozyme than other hydrogel materials and that this protein remains largely active and promotes reduced cytokine response in an in vitro culture of human corneal epithelial cells. This study investigates whether these data transfer to the in vivo situation.
Interventions
DEVICEetafilcon A
etafilcon A soft contact lens
DEVICEnelfilcon A
nelfilcon A
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
1. The subject must read, understand, and sign the Statement of Informed Consent and receive a fully executed copy of the form. 2. The subject must appear able and willing to adhere to the instructions set forth in the clinical protocol. 3. The subject must be willing to follow instructions and maintain the appointment schedule. 4. The subject must be between 18 and 40 years of age (inclusive). 5. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -0.50D to -6.00D in each eye (inclusive). 6. The subject's refractive cylinder must not exceed -1.25DC in each eye after vertexing to the corneal plane. 7. The subject must be a current wearer of spherical, soft contact lenses (no toric, bifocal or multifocal contact lenses, no extended wear or monovision) for at least 5 days/week and at least 8 hours/day during to month prior to enrollment. 8. The subject must own a wearable pair of spectacles and wear them the day of the initial visit. 9. The subject must be an existing wearer of spherical soft contact lenses in both eyes. 10. The subject must have normal eye (i.e., no ocular medications or infections of any type). 11. The subject must be able to wear the study lenses for a minimum seven hours per day.
Exclusion criteria
1. Any ocular or systemic allergies or diseases that may interfere with contact lens wear (at the investigator's discretion). 2. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear (at the investigator's discretion). 3. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued). 4. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease. 5. Any active ocular infection. 6. Is using any topical medication including artificial tears (ATS) up to two weeks prior to the screening visit. 7. Any participants whose habitual contact lenses are used as an extended wear regimen. 8. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by keratometry. 9. Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear; clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear. 10. Any know hypersensitivity or allergic reaction to study products. 11. Participation in any contact lens or lens care product clinical trial within seven days prior to study enrollment. 12. Employee or family member of the Center for Contact Lens Research (e.g., Investigator, Coordinator, Technician).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Protein and Total Lysosome Deposits | 2 wks after baseline | Measurement will be taken after the subject has worn the lenses for a full seven hours |
| Total Protein and Lysosome Deposits | 12 wks after baseline | Measurement will be taken after the subject has worn the lenses for a full seven hours |
| Quantity of Cytokines and Albumin in Tear Fluid | 2 wks after baseline | Measured cytokines: IL-1β, IL-2, IL-6, IL-8, IL-10, IL-12, IL-13, and TNF-alpha Measurement will be taken after the subject has worn the lenses for a full seven hours. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Dispensed Subjects All subjects that were dispensed a study lens. | 28 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 2 | Discontinued at request of Sponsor | 1 | 0 |
| Period 2 | incorrect Rx dispensed | 1 | 0 |
| Period 2 | Protocol Violation | 0 | 1 |
| Period 2 | Test Article longer available | 0 | 1 |
Baseline characteristics
| Characteristic | All Dispensed Subjects |
|---|---|
| Age, Continuous | 23.3 years STANDARD_DEVIATION 4.79 |
| Race/Ethnicity, Customized Asian | 10 Participants |
| Race/Ethnicity, Customized White | 18 Participants |
| Region of Enrollment Canada | 28 Participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 28 | 2 / 28 |
| serious Total, serious adverse events | 0 / 28 | 0 / 28 |
Outcome results
Primary
Quantity of Cytokines and Albumin in Tear Fluid
Measured cytokines: IL-1β, IL-2, IL-6, IL-8, IL-10, IL-12, IL-13, and TNF-alpha Measurement will be taken after the subject has worn the lenses for a full seven hours.
Time frame: 2 wks after baseline
Population: Subjects that completed all study visits without a major protocol deviation. All 24 subjects completed the study, however in some subjects the concentration of cytokine levels were below detectable limits in the tear film sample and could not be analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etafilcon A | Quantity of Cytokines and Albumin in Tear Fluid | TFN-a | 1.20 (pg/ml) | Standard Deviation 0.528 |
| Etafilcon A | Quantity of Cytokines and Albumin in Tear Fluid | IL-1B | 1.70 (pg/ml) | Standard Deviation 1.81 |
| Etafilcon A | Quantity of Cytokines and Albumin in Tear Fluid | IL-2 | 1.19 (pg/ml) | Standard Deviation 0.841 |
| Etafilcon A | Quantity of Cytokines and Albumin in Tear Fluid | IL-6 | 12.32 (pg/ml) | Standard Deviation 11.756 |
| Etafilcon A | Quantity of Cytokines and Albumin in Tear Fluid | IL-8 | 466.32 (pg/ml) | Standard Deviation 291.109 |
| Etafilcon A | Quantity of Cytokines and Albumin in Tear Fluid | IL-10 | 2.02 (pg/ml) | Standard Deviation 1.879 |
| Etafilcon A | Quantity of Cytokines and Albumin in Tear Fluid | IL-12 | 2.72 (pg/ml) | Standard Deviation 5.218 |
| Etafilcon A | Quantity of Cytokines and Albumin in Tear Fluid | IL-13 | 29.62 (pg/ml) | Standard Deviation 19.51 |
| Nelfilcon A | Quantity of Cytokines and Albumin in Tear Fluid | IL-13 | 27.23 (pg/ml) | Standard Deviation 23.651 |
| Nelfilcon A | Quantity of Cytokines and Albumin in Tear Fluid | TFN-a | 1.17 (pg/ml) | Standard Deviation 1.095 |
| Nelfilcon A | Quantity of Cytokines and Albumin in Tear Fluid | IL-8 | 472.91 (pg/ml) | Standard Deviation 273.444 |
| Nelfilcon A | Quantity of Cytokines and Albumin in Tear Fluid | IL-1B | 2.32 (pg/ml) | Standard Deviation 3.023 |
| Nelfilcon A | Quantity of Cytokines and Albumin in Tear Fluid | IL-12 | 2.25 (pg/ml) | Standard Deviation 2.685 |
| Nelfilcon A | Quantity of Cytokines and Albumin in Tear Fluid | IL-2 | 1.49 (pg/ml) | Standard Deviation 1.77 |
| Nelfilcon A | Quantity of Cytokines and Albumin in Tear Fluid | IL-10 | 1.64 (pg/ml) | Standard Deviation 1.389 |
| Nelfilcon A | Quantity of Cytokines and Albumin in Tear Fluid | IL-6 | 15.03 (pg/ml) | Standard Deviation 18.835 |
Primary
Quantity of Cytokines and Albumin in Tear Fluid
Measured cytokines: IL-1β, IL-2, IL-6, IL-8, IL-10, IL-12, IL-13, and TNF-alpha. Measurement will be taken after the subject has worn the lenses for a full seven hours. During the 2nd period subjects continued wearing the current lens that they were randomized to for an additional 6 weeks of wear.
Time frame: 6 wks after baseline
Population: All subjects that completed all study visits without a major protocol deviation. All 12 subjects completed the study, however in some subjects the concentration of cytokine levels were below detectable limits in the tear film sample and could not be analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etafilcon A | Quantity of Cytokines and Albumin in Tear Fluid | IL-8 | 480.99 (pg/ml) | Standard Deviation 353.994 |
| Etafilcon A | Quantity of Cytokines and Albumin in Tear Fluid | IL-2 | 1.50 (pg/ml) | Standard Deviation 1.528 |
| Etafilcon A | Quantity of Cytokines and Albumin in Tear Fluid | IL-10 | 0.90 (pg/ml) | Standard Deviation 1.002 |
| Etafilcon A | Quantity of Cytokines and Albumin in Tear Fluid | TNF-a | 1.20 (pg/ml) | Standard Deviation 1.111 |
| Etafilcon A | Quantity of Cytokines and Albumin in Tear Fluid | IL-12 | 0.42 (pg/ml) | Standard Deviation 0.139 |
| Etafilcon A | Quantity of Cytokines and Albumin in Tear Fluid | IL-6 | 12.70 (pg/ml) | Standard Deviation 11.281 |
| Etafilcon A | Quantity of Cytokines and Albumin in Tear Fluid | IL-13 | 17.78 (pg/ml) | Standard Deviation 17.396 |
| Etafilcon A | Quantity of Cytokines and Albumin in Tear Fluid | IL-1B | 2.83 (pg/ml) | Standard Deviation 1.595 |
| Nelfilcon A | Quantity of Cytokines and Albumin in Tear Fluid | IL-13 | 14.10 (pg/ml) | Standard Deviation 8.998 |
| Nelfilcon A | Quantity of Cytokines and Albumin in Tear Fluid | TNF-a | 0.49 (pg/ml) | Standard Deviation 0.242 |
| Nelfilcon A | Quantity of Cytokines and Albumin in Tear Fluid | IL-2 | 1.06 (pg/ml) | Standard Deviation 0.569 |
| Nelfilcon A | Quantity of Cytokines and Albumin in Tear Fluid | IL-6 | 11.91 (pg/ml) | Standard Deviation 17.135 |
| Nelfilcon A | Quantity of Cytokines and Albumin in Tear Fluid | IL-8 | 481.08 (pg/ml) | Standard Deviation 346.982 |
| Nelfilcon A | Quantity of Cytokines and Albumin in Tear Fluid | IL-10 | 0.55 (pg/ml) | Standard Deviation 0.341 |
| Nelfilcon A | Quantity of Cytokines and Albumin in Tear Fluid | IL-12 | 0.56 (pg/ml) | Standard Deviation 0.222 |
| Nelfilcon A | Quantity of Cytokines and Albumin in Tear Fluid | IL-1B | 4.99 (pg/ml) | Standard Deviation 6.297 |
Primary
Quantity of Cytokines and Albumin in Tear Fluid
Measured cytokines: IL-1β, IL-2, IL-6, IL-8, IL-10, IL-12, IL-13, and TNF-alpha. Measurement will be taken after the subject has worn the lenses for a full seven hours. During the 2nd period subjects continued wearing the current lens that they were randomized to for an additional 6 weeks of wear.
Time frame: 12 wks after baseline
Population: All subjects that completed all study visits without a major protocol deviation. All 12 subjects completed the study, however in some subjects the concentration of cytokine levels were below detectable limits in the tear film sample and could not be analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etafilcon A | Quantity of Cytokines and Albumin in Tear Fluid | TFN-a | 0.57 (pg/ml) | Standard Deviation 0.411 |
| Etafilcon A | Quantity of Cytokines and Albumin in Tear Fluid | IL-1B | 5.18 (pg/ml) | Standard Deviation 6.079 |
| Etafilcon A | Quantity of Cytokines and Albumin in Tear Fluid | IL-2 | 1.43 (pg/ml) | Standard Deviation 1.314 |
| Etafilcon A | Quantity of Cytokines and Albumin in Tear Fluid | IL-6 | 10.18 (pg/ml) | Standard Deviation 6.155 |
| Etafilcon A | Quantity of Cytokines and Albumin in Tear Fluid | IL-8 | 473.86 (pg/ml) | Standard Deviation 164.445 |
| Etafilcon A | Quantity of Cytokines and Albumin in Tear Fluid | IL-10 | 0.85 (pg/ml) | Standard Deviation 1.06 |
| Etafilcon A | Quantity of Cytokines and Albumin in Tear Fluid | IL-12 | 0.74 (pg/ml) | Standard Deviation 0.211 |
| Etafilcon A | Quantity of Cytokines and Albumin in Tear Fluid | IL-13 | 14.56 (pg/ml) | Standard Deviation 5.053 |
| Nelfilcon A | Quantity of Cytokines and Albumin in Tear Fluid | IL-13 | 29.91 (pg/ml) | Standard Deviation 8.963 |
| Nelfilcon A | Quantity of Cytokines and Albumin in Tear Fluid | TFN-a | 0.85 (pg/ml) | Standard Deviation 0.772 |
| Nelfilcon A | Quantity of Cytokines and Albumin in Tear Fluid | IL-8 | 879.82 (pg/ml) | Standard Deviation 922.383 |
| Nelfilcon A | Quantity of Cytokines and Albumin in Tear Fluid | IL-1B | 8.14 (pg/ml) | Standard Deviation 10.25 |
| Nelfilcon A | Quantity of Cytokines and Albumin in Tear Fluid | IL-12 | 0.51 (pg/ml) | Standard Deviation 0.429 |
| Nelfilcon A | Quantity of Cytokines and Albumin in Tear Fluid | IL-2 | 1.09 (pg/ml) | Standard Deviation 0.479 |
| Nelfilcon A | Quantity of Cytokines and Albumin in Tear Fluid | IL-10 | 1.17 (pg/ml) | Standard Deviation 0.618 |
| Nelfilcon A | Quantity of Cytokines and Albumin in Tear Fluid | IL-6 | 21.33 (pg/ml) | Standard Deviation 26.329 |
Primary
Total Protein and Lysosome Deposits
Measurement will be taken after the subject has worn the lenses for a full seven hours
Time frame: 12 wks after baseline
Population: All subjects that completed all study visits without a major protocol deviation.During the 2nd period subjects continued wearing the current lens that they were randomized to for an additional 6 weeks of wear.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etafilcon A | Total Protein and Lysosome Deposits | Total Lysozyme | 289.17 (ug/lens) | Standard Deviation 78.838 |
| Etafilcon A | Total Protein and Lysosome Deposits | Active Lysozymes | 242.75 (ug/lens) | Standard Deviation 57.974 |
| Etafilcon A | Total Protein and Lysosome Deposits | Total Proteins | 394.42 (ug/lens) | Standard Deviation 122.302 |
| Nelfilcon A | Total Protein and Lysosome Deposits | Total Lysozyme | 1.58 (ug/lens) | Standard Deviation 0.851 |
| Nelfilcon A | Total Protein and Lysosome Deposits | Active Lysozymes | 1.01 (ug/lens) | Standard Deviation 0.567 |
| Nelfilcon A | Total Protein and Lysosome Deposits | Total Proteins | 5.87 (ug/lens) | Standard Deviation 3.181 |
Primary
Total Protein and Total Lysosome Deposits
Measurement will be taken after the subject has worn the lenses for a full seven hours
Time frame: 2 wks after baseline
Population: All subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etafilcon A | Total Protein and Total Lysosome Deposits | Total Lysozyme | 294.58 (ug/lens) | Standard Deviation 113.855 |
| Etafilcon A | Total Protein and Total Lysosome Deposits | Active Lysozyme | 244.00 (ug/lens) | Standard Deviation 87.325 |
| Etafilcon A | Total Protein and Total Lysosome Deposits | Total Proteins | 482.06 (ug/lens) | Standard Deviation 139.196 |
| Nelfilcon A | Total Protein and Total Lysosome Deposits | Total Lysozyme | 1.68 (ug/lens) | Standard Deviation 0.975 |
| Nelfilcon A | Total Protein and Total Lysosome Deposits | Active Lysozyme | 0.93 (ug/lens) | Standard Deviation 0.65 |
| Nelfilcon A | Total Protein and Total Lysosome Deposits | Total Proteins | 6.46 (ug/lens) | Standard Deviation 3.953 |
Primary
Total Protein and Total Lysosome Deposits
Measurement will be taken after the subject has worn the lenses for a full seven hours
Time frame: 6 wks after baseline
Population: Subjects that completed all study visits without a major protocol deviation. During the 2nd period subjects continued wearing the current lens that they were randomized to for an additional 6 weeks of wear.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etafilcon A | Total Protein and Total Lysosome Deposits | Total Lysozyme | 349.00 (ug/lens) | Standard Deviation 58.845 |
| Etafilcon A | Total Protein and Total Lysosome Deposits | Active Lysozyme | 263.92 (ug/lens) | Standard Deviation 38.562 |
| Etafilcon A | Total Protein and Total Lysosome Deposits | Total Proteins | 473.58 (ug/lens) | Standard Deviation 131.432 |
| Nelfilcon A | Total Protein and Total Lysosome Deposits | Total Lysozyme | 2.26 (ug/lens) | Standard Deviation 1.46 |
| Nelfilcon A | Total Protein and Total Lysosome Deposits | Active Lysozyme | 1.13 (ug/lens) | Standard Deviation 0.538 |
| Nelfilcon A | Total Protein and Total Lysosome Deposits | Total Proteins | 7.46 (ug/lens) | Standard Deviation 4.151 |