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 I
Multi-purpose contact lens care solution.
Multi-purpose 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 | 3 months | Each subjects' eye was examined using a bio-microscope. Slit lamp findings were graded with a 5-point scale (i.e. Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The number of eyes with Grade 3 or higher for each lens was reported for each assessment. |
| Distance Visual Acuity (LogMAR) | Up to 3 Months | Distance visual acuity was collected at the 1-, 2-, 3-week and 1- and 3- month follow-up evaluations. The average LogMAR across all visits for each lens type was reported. |
Countries
United States
Participant flow
Pre-assignment details
A total of 312 subjects were enrolled in this study. Of the enrolled subjects 12 did not meet the eligibility criteria and 300 were randomized to treatment using an allocation of 2:1 for test and control, respectively. Of the 300 randomized subjects 13 were discontinued from the study and 287 subjects completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Experimental Mutli-purpose Solution Experimental multi-purpose solution (Test treatment) . | 200 |
| ReNu Multi-purpose Solution Marketed multi-purpose solution (Control Treatment). | 100 |
| Total | 300 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Discomfort | 2 | 1 |
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | No Longer Meets Eligibility Criteria | 3 | 0 |
| Overall Study | Protocol Violation | 1 | 1 |
| Overall Study | Subject Disinterest | 1 | 1 |
| Overall Study | Unacceptable lens fit | 1 | 0 |
Baseline characteristics
| Characteristic | Experimental Mutli-purpose Solution | ReNu Multi-purpose Solution | Total |
|---|---|---|---|
| Age, Continuous | 32.40 years STANDARD_DEVIATION 9.231 | 31.05 years STANDARD_DEVIATION 8.624 | 31.73 years STANDARD_DEVIATION 8.928 |
| Race/Ethnicity, Customized American Indian or Native Alaskian | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Asian | 3 participants | 2 participants | 5 participants |
| Race/Ethnicity, Customized Black or African American | 5 participants | 6 participants | 11 participants |
| Race/Ethnicity, Customized Native Hawaiian or other Island Pacificer | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Other | 6 participants | 3 participants | 9 participants |
| Race/Ethnicity, Customized White | 185 participants | 88 participants | 273 participants |
| Region of Enrollment United States | 200 participants | 100 participants | 300 participants |
| Sex: Female, Male Female | 145 Participants | 71 Participants | 216 Participants |
| Sex: Female, Male Male | 55 Participants | 29 Participants | 84 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 200 | 0 / 100 |
| serious Total, serious adverse events | 1 / 200 | 0 / 100 |
Outcome results
Primary
Distance Visual Acuity (LogMAR)
Distance visual acuity was collected at the 1-, 2-, 3-week and 1- and 3- month follow-up evaluations. The average LogMAR across all visits for each lens type was reported.
Time frame: Up to 3 Months
Population: The analysis population consists of subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Multi-purpose Solution | Distance Visual Acuity (LogMAR) | -0.030 LogMAR | Standard Deviation 0.0639 |
| ReNu MultiPlus Multi-Purpose Solution | Distance Visual Acuity (LogMAR) | -0.031 LogMAR | Standard Deviation 0.0634 |
Primary
Slit Lamp Findings
Each subjects' eye was examined using a bio-microscope. Slit lamp findings were graded with a 5-point scale (i.e. Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The number of eyes with Grade 3 or higher for each lens was reported for each assessment.
Time frame: 3 months
Population: The analysis population consists of all subjects that were dispensed a solution during the course of the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Experimental Multi-purpose Solution | Slit Lamp Findings | Corneal Staining | 11 Subjects Eyes |
| Experimental Multi-purpose Solution | Slit Lamp Findings | Conjunctival Staining | 0 Subjects Eyes |
| Experimental Multi-purpose Solution | Slit Lamp Findings | Tarsal Abnormalities | 14 Subjects Eyes |
| ReNu MultiPlus Multi-Purpose Solution | Slit Lamp Findings | Corneal Staining | 16 Subjects Eyes |
| ReNu MultiPlus Multi-Purpose Solution | Slit Lamp Findings | Conjunctival Staining | 0 Subjects Eyes |
| ReNu MultiPlus Multi-Purpose Solution | Slit Lamp Findings | Tarsal Abnormalities | 12 Subjects Eyes |