Contact Lens Wear
Conditions
Keywords
Soft Contact lens, Multi-Purpose Solution, Hydrogen Peroxide
Brief summary
The purpose of this study was to assess comfort in soft contact lens wearers.
Interventions
DEVICEOPTI-FREE RepleniSH multipurpose disinfecting solution
FDA-approved, multipurpose disinfecting solution used according to provided instructions for cleaning, rinsing, storing, and disinfecting study contact lenses on a daily basis, 2 weeks.
DEVICEClear Care contact lens care system
FDA-approved, hydrogen peroxide-based, lens care system used according to provided instructions for cleaning, disinfecting, daily protein removing, and storage of study contact lenses on a daily basis, 2 weeks.
DEVICEContact lenses
Contact lenses per subject's habitual brand and prescription worn every day for the duration of the study, 14 days, on a daily wear basis without scheduled replacement.
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
* Wear silicone hydrogel contact lenses on a daily wear basis; * Currently using OPTI-FREE RepleniSH contact lens solution; * Report comfort above 75 on a Visual Analog Scale at the Baseline Visit; * Read, sign, and date IRB-approved informed consent and the privacy document; * Be generally healthy and have normal ocular health; * Be be willing to follow the study procedures and visit schedule; * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Use of additional lens cleaners; * Known sensitivity to any ingredient in either of the test articles; * Systemic or ocular disease or disorder (except refractive error) that would negatively affect the conduct or outcome of the study; * Prior (within 7 days of enrollment) or current ocular infections; * Clinically significant lash or lid abnormality; * History of ocular surgery/trauma within the last 6 months; * Use of any topical ocular or systemic antibiotics or corticosteroids within 7 days of enrollment; * Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollment; * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Ocular Comfort Rating at 2 Weeks | Baseline (Day 0), 2 weeks | 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. |
| Likert Questionnaire Scores at 2 Weeks | 2 weeks | The Likert Questionnaire included 8 questions on selected comfort measures. All responses were recorded on a 5-point scale, where 1=Strongly Disagree, 2=Disagree, 3=Undecided, 4=Agree, and 5=Strongly Agree. |
Participant flow
Recruitment details
Participants were recruited from two US study centers.
Participants by arm
| Arm | Count |
|---|---|
| OPTI-FREE RepleniSH OPTI-FREE RepleniSH multipurpose disinfecting solution used with study contact lenses on a daily basis for 2 weeks. | 39 |
| Clear Care Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks. | 39 |
| Total | 78 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 |
Baseline characteristics
| Characteristic | OPTI-FREE RepleniSH | Clear Care | Total |
|---|---|---|---|
| Age Continuous | 37.1 years STANDARD_DEVIATION 12.27 | 41.5 years STANDARD_DEVIATION 9.59 | 39.3 years STANDARD_DEVIATION 11.16 |
| Region of Enrollment United States | 39 participants | 39 participants | 78 participants |
| Sex: Female, Male Female | 29 Participants | 26 Participants | 55 Participants |
| Sex: Female, Male Male | 10 Participants | 13 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 39 | 0 / 39 |
| serious Total, serious adverse events | 0 / 39 | 0 / 39 |
Outcome results
Primary
Change From Baseline in Ocular Comfort Rating at 2 Weeks
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.
Time frame: Baseline (Day 0), 2 weeks
Population: All participants who received regimen, satisfied the inclusion/exclusion criteria, and completed the 14-day treatment period, including completion of the Visit 2 evaluations.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| OPTI-FREE RepleniSH | Change From Baseline in Ocular Comfort Rating at 2 Weeks | -8.20 Units on a scale |
| Clear Care | Change From Baseline in Ocular Comfort Rating at 2 Weeks | -7.14 Units on a scale |
Primary
Likert Questionnaire Scores at 2 Weeks
The Likert Questionnaire included 8 questions on selected comfort measures. All responses were recorded on a 5-point scale, where 1=Strongly Disagree, 2=Disagree, 3=Undecided, 4=Agree, and 5=Strongly Agree.
Time frame: 2 weeks
Population: All participants who received regimen, satisfied the inclusion/exclusion criteria, and completed the 14-day treatment period, including completion of the Visit 2 evaluations.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| OPTI-FREE RepleniSH | Likert Questionnaire Scores at 2 Weeks | I can comfortably wear my lenses | 4.20 Units on a scale |
| OPTI-FREE RepleniSH | Likert Questionnaire Scores at 2 Weeks | My lenses stay moist from morning to evening | 3.60 Units on a scale |
| OPTI-FREE RepleniSH | Likert Questionnaire Scores at 2 Weeks | The solution I use feels gentle on my eyes | 4.00 Units on a scale |
| OPTI-FREE RepleniSH | Likert Questionnaire Scores at 2 Weeks | At the end of the day, my vision is clear | 3.54 Units on a scale |
| OPTI-FREE RepleniSH | Likert Questionnaire Scores at 2 Weeks | When I put my lenses in, they feel comfortable | 4.05 Units on a scale |
| OPTI-FREE RepleniSH | Likert Questionnaire Scores at 2 Weeks | I like the way this product feels during handling | 4.09 Units on a scale |
| OPTI-FREE RepleniSH | Likert Questionnaire Scores at 2 Weeks | My lenses feel moist | 3.84 Units on a scale |
| OPTI-FREE RepleniSH | Likert Questionnaire Scores at 2 Weeks | My lenses feel fresh | 3.79 Units on a scale |
| Clear Care | Likert Questionnaire Scores at 2 Weeks | At the end of the day, my vision is clear | 3.86 Units on a scale |
| Clear Care | Likert Questionnaire Scores at 2 Weeks | I can comfortably wear my lenses | 4.24 Units on a scale |
| Clear Care | Likert Questionnaire Scores at 2 Weeks | I like the way this product feels during handling | 3.66 Units on a scale |
| Clear Care | Likert Questionnaire Scores at 2 Weeks | My lenses stay moist from morning to evening | 3.69 Units on a scale |
| Clear Care | Likert Questionnaire Scores at 2 Weeks | When I put my lenses in, they feel comfortable | 4.03 Units on a scale |
| Clear Care | Likert Questionnaire Scores at 2 Weeks | The solution I use feels gentle on my eyes | 3.66 Units on a scale |
| Clear Care | Likert Questionnaire Scores at 2 Weeks | My lenses feel fresh | 4.03 Units on a scale |
| Clear Care | Likert Questionnaire Scores at 2 Weeks | My lenses feel moist | 3.64 Units on a scale |