Myopia, Astigmatism, Refractive Error
Conditions
Keywords
Soft contact lenses, Multi-purpose Solution
Brief summary
The purpose of this study was to assess the comfort of OPTI-FREE RepleniSH in soft contact lens wearers.
Interventions
DEVICEOPTI-FREE RepleniSH multipurpose solution
FDA-approved, multipurpose solution used as indicated for cleaning, rinsing, conditioning, disinfecting, and storing study contact lenses on a daily wear basis for 14 days
DEVICEReNu Biotrue multipurpose solution
FDA-approved, multipurpose solution used as indicated for cleaning, disinfecting, daily protein removing, and storing study contact lenses on a daily wear basis for 14 days
Silicone hydrogel contact lenses per subject's habitual brand and prescription worn on a daily wear basis for 14 days, with either OPTI-FREE RepleniSH or ReNu Biotrue used for contact lens care
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Currently wearing silicone hydrogel contact lenses on a daily wear basis; * Currently using OPTI-FREE RepleniSH contact lens solution; * Generally healthy; * Normal ocular health; * Willing to follow study procedures and visit schedule; * Sign Informed Consent and privacy document; * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Use of additional lens cleaners; * Known sensitivities to any ingredient in either test article; * Systemic or ocular disease or disorder that would negatively affect the conduct or outcome of the study; * History of ocular surgery/trauma within the last 6 months; * Any topical ocular or systemic antibiotics within 7 days of enrollment continuing throughout the study; * Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollent; * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline (Day 0) in Ocular Comfort Rating at Day 14 | Baseline (Day 0), Day 14 | Ocular comfort was rated by the participant on a continuous visual analog scale from 0-100, where 0=extremely uncomfortable, 50=neither comfortable nor uncomfortable, and 100=extremely comfortable. The participant marked a horizontal line across the scale at the point that best described, how your eyes feel right now. A positive number indicates increased ocular comfort; a negative number indicates decreased ocular comfort. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OPTI-FREE RepleniSH OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days | 52 |
| ReNu Biotrue ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days | 52 |
| Total | 104 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
Baseline characteristics
| Characteristic | OPTI-FREE RepleniSH | ReNu Biotrue | Total |
|---|---|---|---|
| Age Continuous | 33.3 years STANDARD_DEVIATION 10.4 | 35.4 years STANDARD_DEVIATION 10.96 | 34.3 years STANDARD_DEVIATION 10.71 |
| Sex: Female, Male Female | 14 Participants | 10 Participants | 24 Participants |
| Sex: Female, Male Male | 38 Participants | 42 Participants | 80 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 52 | 0 / 52 |
| serious Total, serious adverse events | 0 / 52 | 0 / 52 |
Outcome results
Primary
Change From Baseline (Day 0) in Ocular Comfort Rating at Day 14
Ocular comfort was rated by the participant on a continuous visual analog scale from 0-100, where 0=extremely uncomfortable, 50=neither comfortable nor uncomfortable, and 100=extremely comfortable. The participant marked a horizontal line across the scale at the point that best described, how your eyes feel right now. A positive number indicates increased ocular comfort; a negative number indicates decreased ocular comfort.
Time frame: Baseline (Day 0), Day 14
Population: All participants who received regimen, satisfied inclusion/exclusion criteria, and completed the 14-day treatment period (per protocol)
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| OPTI-FREE RepleniSH | Change From Baseline (Day 0) in Ocular Comfort Rating at Day 14 | Baseline (Day 0) | 87.40 Units on a scale |
| OPTI-FREE RepleniSH | Change From Baseline (Day 0) in Ocular Comfort Rating at Day 14 | Change from Baseline (Day 0) at Day 14 | -5.65 Units on a scale |
| OPTI-FREE RepleniSH | Change From Baseline (Day 0) in Ocular Comfort Rating at Day 14 | Day 14 | 81.75 Units on a scale |
| ReNu Biotrue | Change From Baseline (Day 0) in Ocular Comfort Rating at Day 14 | Baseline (Day 0) | 88.79 Units on a scale |
| ReNu Biotrue | Change From Baseline (Day 0) in Ocular Comfort Rating at Day 14 | Day 14 | 83.18 Units on a scale |
| ReNu Biotrue | Change From Baseline (Day 0) in Ocular Comfort Rating at Day 14 | Change from Baseline (Day 0) at Day 14 | -5.61 Units on a scale |