Contact Lens Wear
Conditions
Brief summary
This study compares an investigational contact lens care multi-purpose solution to a currently marketed multi-purpose solution.
Interventions
DEVICEVistakon Investigational Multi-Purpose Solution II
contact lens care solution
contact lens care solution
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* must be an adapted contact lens wearer * best corrected distance visual acuity must be 20/25 or better in each eye * must be wearing their habitual lenses on a daily wear basis * must be willing to refrain from swimming during the study
Exclusion criteria
* any systemic diseases that may interfere with contact lens wear * any clinically significant ocular disease * any ocular infection * use of certain medications * any grade 2 or greater slit lamp findings * any know sensitivity to marketed contact lens care solutions * currently pregnant or lactating * monovision corrected
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Slit Lamp Findings (SLF) | Up to 3 months Post Lens Wear | Slit Lamp Findings were assessed for each subject eye at baseline, 1-day, 1-week, 2-week, 1-month and 3-month follow-up evaluations. SLF consisted of Edema, Corneal Neovascularization, Cornela Staining, Injection, Tarsal Abnormalities and Other findings; each was graded on a 5-likert Scale (Grade: None, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate and Grade 4: Severe). The number of eyes with Grade 2 or higher across all time points for each SLF variable was reported. |
| Distance Visual Acuity (LogMAR) | Up to 3 Months Post Lens Wear | Distance Visual Acuity (LogMAR) was assessed for each subject eye at 1-week, 2-week, 1-month and 3-month follow-up evaluations. The average Visual Acuity (LogMAR) for each time point and lens was reported. |
Countries
United States
Participant flow
Recruitment details
A total of 315 subjects were enrolled in this study. Of the enrolled subjects 20 did not meet the eligibility criteria and 295 subjects were randomized to treatment.Of the randomized subjects 16 were discontinued from the study, while 279 completed the study.
Pre-assignment details
Allocation of subjects to the 5 contact lenses was fairly balanced ranging from 57 to 61 subjects per lens, while the allocation of subjects to solution was 2:1 for the test and control solution respectively.
Participants by arm
| Arm | Count |
|---|---|
| Solution 1 (Etafilcon A) All subjects that were dispensed solution 1 and the etafilcon A lens. | 40 |
| Solution 1 (Comfilcon A) All subjects that were dispensed solution 1 and the comfilcon A study lens. | 40 |
| Solution 1 (Balafilcon A) All subjects that were dispensed solution 1 and the balafilcon A study lens. | 38 |
| Solution 1 (Lotrafilcon A) All subjects that were dispensed solution 1 and the lotrafilcon A study lens. | 40 |
| Solution 1 (Galyfilcon A) All subjects that were dispensed solution 1 and the galyfilcon A study lens. | 41 |
| Solution 2 (Etafilcon A) All subjects that were dispensed solution 2 and etafilcon A study lens. | 18 |
| Solution 2 (Comfilcon A) All subjects that were dispensed solution 2 and the comfilcon A study lens. | 19 |
| Solution 2 (Balafilcon A) All subjects that were dispensed solution 2 and balafilcon A study lens. | 19 |
| Solution 2 (Lotrafilcon A) All subjects that were dispensed solution 2 and the lotrafilcon A study lens. | 20 |
| Solution 2 (Galyfilcon A) All subjects that were dispensed solution 2 and the galyfilcon A study lens. | 20 |
| Total | 295 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Discomfort | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Pregnancy | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 1 | 1 | 1 | 2 | 1 | 0 | 0 | 1 |
| Overall Study | Subject Disinterest | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Subject Ineligible | 1 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Solution 1 (Etafilcon A) | Solution 1 (Comfilcon A) | Solution 1 (Balafilcon A) | Solution 1 (Lotrafilcon A) | Solution 1 (Galyfilcon A) | Solution 2 (Etafilcon A) | Solution 2 (Comfilcon A) | Solution 2 (Balafilcon A) | Solution 2 (Lotrafilcon A) | Solution 2 (Galyfilcon A) | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous Solution 1(etafilcon A) | 30.17 years STANDARD_DEVIATION 8.692 | 31.58 years STANDARD_DEVIATION 9.459 | 32.16 years STANDARD_DEVIATION 8.526 | 29.45 years STANDARD_DEVIATION 9.333 | 29.10 years STANDARD_DEVIATION 7.993 | 32.48 years STANDARD_DEVIATION 7.845 | 29.95 years STANDARD_DEVIATION 6.417 | 34.26 years STANDARD_DEVIATION 8.738 | 30.10 years STANDARD_DEVIATION 9.554 | 32.15 years STANDARD_DEVIATION 8.079 | 30.89 years STANDARD_DEVIATION 9.012 |
| Region of Enrollment United States | 40 participants | 40 participants | 38 participants | 40 participants | 41 participants | 18 participants | 19 participants | 19 participants | 20 participants | 20 participants | 295 participants |
| Sex: Female, Male Female | 25 Participants | 28 Participants | 24 Participants | 25 Participants | 31 Participants | 13 Participants | 9 Participants | 12 Participants | 13 Participants | 9 Participants | 189 Participants |
| Sex: Female, Male Male | 15 Participants | 12 Participants | 14 Participants | 15 Participants | 10 Participants | 5 Participants | 10 Participants | 7 Participants | 7 Participants | 11 Participants | 106 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 | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 40 | 0 / 40 | 0 / 38 | 0 / 40 | 2 / 41 | 0 / 18 | 1 / 19 | 1 / 19 | 0 / 20 | 1 / 20 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 | 0 / 38 | 1 / 40 | 0 / 41 | 0 / 18 | 0 / 19 | 0 / 19 | 0 / 20 | 0 / 20 |
Outcome results
Primary
Distance Visual Acuity (LogMAR)
Distance Visual Acuity (LogMAR) was assessed for each subject eye at 1-week, 2-week, 1-month and 3-month follow-up evaluations. The average Visual Acuity (LogMAR) for each time point and lens was reported.
Time frame: Up to 3 Months Post Lens Wear
Population: All subjects that completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Solution1 (Etafilcon A) | Distance Visual Acuity (LogMAR) | 1-week | -0.033 LogMAR | Standard Deviation 0.0601 |
| Solution1 (Etafilcon A) | Distance Visual Acuity (LogMAR) | 1-Month | -0.045 LogMAR | Standard Deviation 0.0623 |
| Solution1 (Etafilcon A) | Distance Visual Acuity (LogMAR) | 3-Month | -0.045 LogMAR | Standard Deviation 0.0673 |
| Solution1 (Etafilcon A) | Distance Visual Acuity (LogMAR) | 2-week | -0.045 LogMAR | Standard Deviation 0.0642 |
| Solution1 (Comfilcon A) | Distance Visual Acuity (LogMAR) | 2-week | -0.041 LogMAR | Standard Deviation 0.0663 |
| Solution1 (Comfilcon A) | Distance Visual Acuity (LogMAR) | 1-week | -0.042 LogMAR | Standard Deviation 0.063 |
| Solution1 (Comfilcon A) | Distance Visual Acuity (LogMAR) | 3-Month | -0.031 LogMAR | Standard Deviation 0.0609 |
| Solution1 (Comfilcon A) | Distance Visual Acuity (LogMAR) | 1-Month | -0.042 LogMAR | Standard Deviation 0.0644 |
| Solution1 (Balafilcon A) | Distance Visual Acuity (LogMAR) | 3-Month | -0.039 LogMAR | Standard Deviation 0.0617 |
| Solution1 (Balafilcon A) | Distance Visual Acuity (LogMAR) | 1-week | -0.037 LogMAR | Standard Deviation 0.0563 |
| Solution1 (Balafilcon A) | Distance Visual Acuity (LogMAR) | 2-week | -0.047 LogMAR | Standard Deviation 0.0592 |
| Solution1 (Balafilcon A) | Distance Visual Acuity (LogMAR) | 1-Month | -0.033 LogMAR | Standard Deviation 0.0658 |
| Solution1 (Lotrafilcon A) | Distance Visual Acuity (LogMAR) | 1-Month | -0.040 LogMAR | Standard Deviation 0.0628 |
| Solution1 (Lotrafilcon A) | Distance Visual Acuity (LogMAR) | 3-Month | -0.038 LogMAR | Standard Deviation 0.0607 |
| Solution1 (Lotrafilcon A) | Distance Visual Acuity (LogMAR) | 1-week | -0.040 LogMAR | Standard Deviation 0.0665 |
| Solution1 (Lotrafilcon A) | Distance Visual Acuity (LogMAR) | 2-week | -0.039 LogMAR | Standard Deviation 0.0649 |
| Solution1 (Galyfilcon A) | Distance Visual Acuity (LogMAR) | 1-Month | -0.037 LogMAR | Standard Deviation 0.0595 |
| Solution1 (Galyfilcon A) | Distance Visual Acuity (LogMAR) | 3-Month | -0.031 LogMAR | Standard Deviation 0.0613 |
| Solution1 (Galyfilcon A) | Distance Visual Acuity (LogMAR) | 2-week | -0.037 LogMAR | Standard Deviation 0.0594 |
| Solution1 (Galyfilcon A) | Distance Visual Acuity (LogMAR) | 1-week | -0.029 LogMAR | Standard Deviation 0.0615 |
| Solution2 (Etafilcon A) | Distance Visual Acuity (LogMAR) | 1-Month | -0.068 LogMAR | Standard Deviation 0.0541 |
| Solution2 (Etafilcon A) | Distance Visual Acuity (LogMAR) | 1-week | -0.055 LogMAR | Standard Deviation 0.058 |
| Solution2 (Etafilcon A) | Distance Visual Acuity (LogMAR) | 2-week | -0.058 LogMAR | Standard Deviation 0.0585 |
| Solution2 (Etafilcon A) | Distance Visual Acuity (LogMAR) | 3-Month | -0.051 LogMAR | Standard Deviation 0.0668 |
| Solution2 (Comfilcon A) | Distance Visual Acuity (LogMAR) | 2-week | -0.045 LogMAR | Standard Deviation 0.0642 |
| Solution2 (Comfilcon A) | Distance Visual Acuity (LogMAR) | 1-week | -0.033 LogMAR | Standard Deviation 0.0601 |
| Solution2 (Comfilcon A) | Distance Visual Acuity (LogMAR) | 3-Month | -0.045 LogMAR | Standard Deviation 0.0673 |
| Solution2 (Comfilcon A) | Distance Visual Acuity (LogMAR) | 1-Month | -0.045 LogMAR | Standard Deviation 0.0623 |
| Solution2 (Balafilcon A) | Distance Visual Acuity (LogMAR) | 3-Month | -0.034 LogMAR | Standard Deviation 0.0567 |
| Solution2 (Balafilcon A) | Distance Visual Acuity (LogMAR) | 1-Month | -0.026 LogMAR | Standard Deviation 0.0534 |
| Solution2 (Balafilcon A) | Distance Visual Acuity (LogMAR) | 2-week | -0.051 LogMAR | Standard Deviation 0.0625 |
| Solution2 (Balafilcon A) | Distance Visual Acuity (LogMAR) | 1-week | -0.040 LogMAR | Standard Deviation 0.054 |
| Solution2 (Lotrafilcon A) | Distance Visual Acuity (LogMAR) | 1-week | -0.045 LogMAR | Standard Deviation 0.0685 |
| Solution2 (Lotrafilcon A) | Distance Visual Acuity (LogMAR) | 1-Month | -0.031 LogMAR | Standard Deviation 0.0626 |
| Solution2 (Lotrafilcon A) | Distance Visual Acuity (LogMAR) | 2-week | -0.031 LogMAR | Standard Deviation 0.0551 |
| Solution2 (Lotrafilcon A) | Distance Visual Acuity (LogMAR) | 3-Month | -0.014 LogMAR | Standard Deviation 0.0618 |
| Solution2 (Galyfilcon A) | Distance Visual Acuity (LogMAR) | 1-week | -0.012 LogMAR | Standard Deviation 0.0619 |
| Solution2 (Galyfilcon A) | Distance Visual Acuity (LogMAR) | 1-Month | -0.032 LogMAR | Standard Deviation 0.061 |
| Solution2 (Galyfilcon A) | Distance Visual Acuity (LogMAR) | 3-Month | -0.040 LogMAR | Standard Deviation 0.0614 |
| Solution2 (Galyfilcon A) | Distance Visual Acuity (LogMAR) | 2-week | -0.030 LogMAR | Standard Deviation 0.0595 |
Primary
Slit Lamp Findings (SLF)
Slit Lamp Findings were assessed for each subject eye at baseline, 1-day, 1-week, 2-week, 1-month and 3-month follow-up evaluations. SLF consisted of Edema, Corneal Neovascularization, Cornela Staining, Injection, Tarsal Abnormalities and Other findings; each was graded on a 5-likert Scale (Grade: None, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate and Grade 4: Severe). The number of eyes with Grade 2 or higher across all time points for each SLF variable was reported.
Time frame: Up to 3 months Post Lens Wear
Population: All subjects that completed the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Solution1 (Etafilcon A) | Slit Lamp Findings (SLF) | Injection | 1 eyes (2 per subject) |
| Solution1 (Etafilcon A) | Slit Lamp Findings (SLF) | Edema | 0 eyes (2 per subject) |
| Solution1 (Etafilcon A) | Slit Lamp Findings (SLF) | Tarsal Abnormalities | 15 eyes (2 per subject) |
| Solution1 (Etafilcon A) | Slit Lamp Findings (SLF) | Corneal Neovascularization | 0 eyes (2 per subject) |
| Solution1 (Etafilcon A) | Slit Lamp Findings (SLF) | Other Findings | 6 eyes (2 per subject) |
| Solution1 (Etafilcon A) | Slit Lamp Findings (SLF) | Corneal Staining | 8 eyes (2 per subject) |
| Solution1 (Comfilcon A) | Slit Lamp Findings (SLF) | Injection | 0 eyes (2 per subject) |
| Solution1 (Comfilcon A) | Slit Lamp Findings (SLF) | Corneal Staining | 16 eyes (2 per subject) |
| Solution1 (Comfilcon A) | Slit Lamp Findings (SLF) | Edema | 0 eyes (2 per subject) |
| Solution1 (Comfilcon A) | Slit Lamp Findings (SLF) | Other Findings | 3 eyes (2 per subject) |
| Solution1 (Comfilcon A) | Slit Lamp Findings (SLF) | Corneal Neovascularization | 0 eyes (2 per subject) |
| Solution1 (Comfilcon A) | Slit Lamp Findings (SLF) | Tarsal Abnormalities | 10 eyes (2 per subject) |
| Solution1 (Balafilcon A) | Slit Lamp Findings (SLF) | Tarsal Abnormalities | 10 eyes (2 per subject) |
| Solution1 (Balafilcon A) | Slit Lamp Findings (SLF) | Corneal Staining | 14 eyes (2 per subject) |
| Solution1 (Balafilcon A) | Slit Lamp Findings (SLF) | Corneal Neovascularization | 0 eyes (2 per subject) |
| Solution1 (Balafilcon A) | Slit Lamp Findings (SLF) | Injection | 1 eyes (2 per subject) |
| Solution1 (Balafilcon A) | Slit Lamp Findings (SLF) | Other Findings | 1 eyes (2 per subject) |
| Solution1 (Balafilcon A) | Slit Lamp Findings (SLF) | Edema | 0 eyes (2 per subject) |
| Solution1 (Lotrafilcon A) | Slit Lamp Findings (SLF) | Corneal Staining | 12 eyes (2 per subject) |
| Solution1 (Lotrafilcon A) | Slit Lamp Findings (SLF) | Edema | 0 eyes (2 per subject) |
| Solution1 (Lotrafilcon A) | Slit Lamp Findings (SLF) | Tarsal Abnormalities | 10 eyes (2 per subject) |
| Solution1 (Lotrafilcon A) | Slit Lamp Findings (SLF) | Other Findings | 0 eyes (2 per subject) |
| Solution1 (Lotrafilcon A) | Slit Lamp Findings (SLF) | Corneal Neovascularization | 0 eyes (2 per subject) |
| Solution1 (Lotrafilcon A) | Slit Lamp Findings (SLF) | Injection | 0 eyes (2 per subject) |
| Solution1 (Galyfilcon A) | Slit Lamp Findings (SLF) | Corneal Neovascularization | 0 eyes (2 per subject) |
| Solution1 (Galyfilcon A) | Slit Lamp Findings (SLF) | Other Findings | 0 eyes (2 per subject) |
| Solution1 (Galyfilcon A) | Slit Lamp Findings (SLF) | Tarsal Abnormalities | 2 eyes (2 per subject) |
| Solution1 (Galyfilcon A) | Slit Lamp Findings (SLF) | Edema | 0 eyes (2 per subject) |
| Solution1 (Galyfilcon A) | Slit Lamp Findings (SLF) | Injection | 3 eyes (2 per subject) |
| Solution1 (Galyfilcon A) | Slit Lamp Findings (SLF) | Corneal Staining | 6 eyes (2 per subject) |
| Solution2 (Etafilcon A) | Slit Lamp Findings (SLF) | Tarsal Abnormalities | 0 eyes (2 per subject) |
| Solution2 (Etafilcon A) | Slit Lamp Findings (SLF) | Injection | 1 eyes (2 per subject) |
| Solution2 (Etafilcon A) | Slit Lamp Findings (SLF) | Edema | 0 eyes (2 per subject) |
| Solution2 (Etafilcon A) | Slit Lamp Findings (SLF) | Corneal Neovascularization | 0 eyes (2 per subject) |
| Solution2 (Etafilcon A) | Slit Lamp Findings (SLF) | Corneal Staining | 8 eyes (2 per subject) |
| Solution2 (Etafilcon A) | Slit Lamp Findings (SLF) | Other Findings | 0 eyes (2 per subject) |
| Solution2 (Comfilcon A) | Slit Lamp Findings (SLF) | Corneal Neovascularization | 0 eyes (2 per subject) |
| Solution2 (Comfilcon A) | Slit Lamp Findings (SLF) | Injection | 2 eyes (2 per subject) |
| Solution2 (Comfilcon A) | Slit Lamp Findings (SLF) | Corneal Staining | 3 eyes (2 per subject) |
| Solution2 (Comfilcon A) | Slit Lamp Findings (SLF) | Other Findings | 0 eyes (2 per subject) |
| Solution2 (Comfilcon A) | Slit Lamp Findings (SLF) | Tarsal Abnormalities | 1 eyes (2 per subject) |
| Solution2 (Comfilcon A) | Slit Lamp Findings (SLF) | Edema | 0 eyes (2 per subject) |
| Solution2 (Balafilcon A) | Slit Lamp Findings (SLF) | Tarsal Abnormalities | 6 eyes (2 per subject) |
| Solution2 (Balafilcon A) | Slit Lamp Findings (SLF) | Edema | 0 eyes (2 per subject) |
| Solution2 (Balafilcon A) | Slit Lamp Findings (SLF) | Corneal Neovascularization | 0 eyes (2 per subject) |
| Solution2 (Balafilcon A) | Slit Lamp Findings (SLF) | Injection | 4 eyes (2 per subject) |
| Solution2 (Balafilcon A) | Slit Lamp Findings (SLF) | Other Findings | 0 eyes (2 per subject) |
| Solution2 (Balafilcon A) | Slit Lamp Findings (SLF) | Corneal Staining | 28 eyes (2 per subject) |
| Solution2 (Lotrafilcon A) | Slit Lamp Findings (SLF) | Other Findings | 0 eyes (2 per subject) |
| Solution2 (Lotrafilcon A) | Slit Lamp Findings (SLF) | Corneal Staining | 12 eyes (2 per subject) |
| Solution2 (Lotrafilcon A) | Slit Lamp Findings (SLF) | Corneal Neovascularization | 0 eyes (2 per subject) |
| Solution2 (Lotrafilcon A) | Slit Lamp Findings (SLF) | Edema | 0 eyes (2 per subject) |
| Solution2 (Lotrafilcon A) | Slit Lamp Findings (SLF) | Tarsal Abnormalities | 9 eyes (2 per subject) |
| Solution2 (Lotrafilcon A) | Slit Lamp Findings (SLF) | Injection | 0 eyes (2 per subject) |
| Solution2 (Galyfilcon A) | Slit Lamp Findings (SLF) | Tarsal Abnormalities | 1 eyes (2 per subject) |
| Solution2 (Galyfilcon A) | Slit Lamp Findings (SLF) | Other Findings | 0 eyes (2 per subject) |
| Solution2 (Galyfilcon A) | Slit Lamp Findings (SLF) | Corneal Staining | 8 eyes (2 per subject) |
| Solution2 (Galyfilcon A) | Slit Lamp Findings (SLF) | Edema | 0 eyes (2 per subject) |
| Solution2 (Galyfilcon A) | Slit Lamp Findings (SLF) | Corneal Neovascularization | 0 eyes (2 per subject) |
| Solution2 (Galyfilcon A) | Slit Lamp Findings (SLF) | Injection | 3 eyes (2 per subject) |