Myopia
Conditions
Keywords
contact lens solution, OPTI-FREE RepleniSH, contact lenses
Brief summary
The purpose of this study was to demonstrate that current successful fulltime daily wear soft contact lens wearers using competitive multi-purpose solutions will note improved comfort when using OPTI-FREE RepleniSH®.
Interventions
DEVICEMulti-Purpose Disinfecting Solution (OPTI-FREE RepleniSH)
OPTI-FREE RepleniSH® used according to product labeled instructions for cleaning and disinfecting study contact lenses, 30 days.
DEVICEContact Lenses
Contact lenses per participant's habitual prescription removed nightly for cleaning and disinfecting.
Sponsors
Alcon Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Participants must be between 18 and 65 years of age. 2. Must wear daily wear soft contact lenses a minimum of 8 hours per day,7 days a week. 3. Must be wearing a planned replacement soft lens in a 2 week or monthly replacement modality. 4. Must be using either COMPLETE Multi-Purpose Solution (MPS) Easy Rub or ReNu MultiPlus brand solution for at least 30 continuous days prior to enrollment. 5. Must be free of any contact lens-related symptoms with regard to comfort and vision throughout their wearing hours prior to enrollment, with the exception of end-of-day dryness not limiting all day wear. 6. Must have best corrected distance visual acuity, with contact lenses, of 20/30 or better in each eye. 7. Must be willing to maintain pre-enrollment systemic medication regimens during the study. 8. Must be willing to not use any topical medications or rewetting drops during the 30 day clinical trial duration. 9. Other protocol-defined inclusion criteria may apply.
Exclusion criteria
1. Has used any topical medication or rewetting drops for 7 days prior to enrollment. 2. Achieves best visual correction by monovision. 3. Has modified their systemic medications within 30 days prior to enrollment. 4. Has switched brands of cosmetics during the 30 days prior to the study. 5. Has a history of allergy to any study product ingredients. 6. Is unwilling or unable to meet the study visit timeline. 7. Has any active corneal, eyelid or other anterior segment inflammation or infection, which, in the opinion of the Investigator, would adversely affect successful contact lens wear. 8. Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comfort Ratings at Baseline | Baseline (Day 0) | Prior to any ocular assessments at the visit, comfort ratings were collected on a questionnaire using 5-point Likert scale, with 1=Strongly Agree, 1=Agree, 3=Neutral, 4=Disagree, 5=Strongly Disagree. The percentage of participants responding with Strongly Agree or Agree for each question is presented. |
| Comfort Ratings at 30 Days | 30 days | Prior to any ocular assessments at the visit, comfort ratings were collected on a questionnaire using 5-point Likert scale, with 1=Strongly Agree, 1=Agree, 3=Neutral, 4=Disagree, 5=Strongly Disagree. The percentage of participants responding with Strongly Agree or Agree for each question is presented. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from 6 US study sites.
Participants by arm
| Arm | Count |
|---|---|
| Opti-Free Replenish Multi-purpose contact lens solution for cleaning and disinfecting study contact lenses used on a daily basis for 30 days. | 114 |
| Total | 114 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawn | 3 |
Baseline characteristics
| Characteristic | Opti-Free Replenish |
|---|---|
| Age Continuous | 36 years |
| Region of Enrollment United States | 114 participants |
| Sex: Female, Male Female | 81 Participants |
| Sex: Female, Male Male | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 114 |
| serious Total, serious adverse events | 0 / 114 |
Outcome results
Primary
Comfort Ratings at 30 Days
Prior to any ocular assessments at the visit, comfort ratings were collected on a questionnaire using 5-point Likert scale, with 1=Strongly Agree, 1=Agree, 3=Neutral, 4=Disagree, 5=Strongly Disagree. The percentage of participants responding with Strongly Agree or Agree for each question is presented.
Time frame: 30 days
Population: 5 participants were excluded from analysis due to discontinuation of contact lens wear (1), treatment during study that might interfere with study outcome (1), and withdrawal (3).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Opti-Free Replenish | Comfort Ratings at 30 Days | My lens is comfortable upon instillation | 92 Percentage of Participants |
| Opti-Free Replenish | Comfort Ratings at 30 Days | My lenses feel comfortable at the end of the day | 88 Percentage of Participants |
| Opti-Free Replenish | Comfort Ratings at 30 Days | My vision is clear at the end of the day | 91 Percentage of Participants |
| Opti-Free Replenish | Comfort Ratings at 30 Days | I am satisfied with my overall lens experience | 91 Percentage of Participants |
| Opti-Free Replenish | Comfort Ratings at 30 Days | Study product enhances wearing experience more | 71 Percentage of Participants |
| Opti-Free Replenish | Comfort Ratings at 30 Days | I will continue to use the study solution after | 81 Percentage of Participants |
Primary
Comfort Ratings at Baseline
Prior to any ocular assessments at the visit, comfort ratings were collected on a questionnaire using 5-point Likert scale, with 1=Strongly Agree, 1=Agree, 3=Neutral, 4=Disagree, 5=Strongly Disagree. The percentage of participants responding with Strongly Agree or Agree for each question is presented.
Time frame: Baseline (Day 0)
Population: 6 participants were excluded from analysis due to discontinuation of contact lens wear (1), treatment during study that might interfere with study outcome (1), withdrawal (3), and missing responses (1).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Opti-Free Replenish | Comfort Ratings at Baseline | My lens is comfortable upon instillation | 86 Percentage of Participants |
| Opti-Free Replenish | Comfort Ratings at Baseline | My lenses feel comfortable at the end of the day | 59 Percentage of Participants |
| Opti-Free Replenish | Comfort Ratings at Baseline | My vision is clear at the end of the day | 57 Percentage of Participants |
| Opti-Free Replenish | Comfort Ratings at Baseline | I am satisfied with my overall lens experience | 81 Percentage of Participants |