Symptomatic Contact Lens Wearers
Conditions
Keywords
Symptomatic, Contact lens care, Multi-purpose solution
Brief summary
The purpose of this study is to compare two contact lens care solutions in symptomatic wearers of silicone hydrogel contact lenses.
Interventions
Investigational multi-purpose disinfecting solution used by subjects as specified in use instructions provided for the care of study contact lenses, 30 days.
Commercially available multi-purpose solution used by subjects as indicated for care of study contact lenses, 30 days.
DEVICEContact lenses
Contact lenses per subject's habitual brand and power worn for 30 days on a daily wear basis.
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
* Symptomatic silicone hydrogel contact lens wearers who wear their lenses daily wear (i.e., disinfect lenses every night). * Vision correctable to 20/30 or better with contact lenses. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Sensitivity to multi-purpose solutions. * Use of any topical ocular OTC or prescribed topical ocular medications. * History (6 months) or current ocular infections or ocular inflammatory events. * Ocular surgery within the past year. * Medical condition or use of medications that cause ocular side effects. * Participation in any investigational study within the past 30 days. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Likert Statement: When I Use This Solution, I Can Comfortably Wear my Lenses. | Day 30 | As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Likert Statement: When I Use This Solution, My Lenses Are Comfortable From Morning Until Evening. | Day 30 | As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree. |
| Likert Statement: When I Use This Solution, I Forget I am Wearing my Lenses. | Day 30 | As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited and enrolled from 42 US study centers.
Pre-assignment details
The Participant Flow Chart includes all randomized patients: 591. Baseline characteristics are presented for all subjects who received test article and had at least one on-regimen study visit: 578.
Participants by arm
| Arm | Count |
|---|---|
| Alcon MPDS Multi-purpose disinfecting contact lens solution | 288 |
| Renu Fresh MPS Multi-purpose contact lens solution | 290 |
| Total | 578 |
Baseline characteristics
| Characteristic | Alcon MPDS | Renu Fresh MPS | Total |
|---|---|---|---|
| Age Continuous | 34.5 years STANDARD_DEVIATION 11.43 | 34.0 years STANDARD_DEVIATION 11.24 | 34.3 years STANDARD_DEVIATION 11.33 |
| Sex: Female, Male Female | 209 Participants | 212 Participants | 421 Participants |
| Sex: Female, Male Male | 79 Participants | 78 Participants | 157 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 292 | 0 / 297 |
| serious Total, serious adverse events | 1 / 292 | 1 / 297 |
Outcome results
Primary
Likert Statement: When I Use This Solution, I Can Comfortably Wear my Lenses.
As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree.
Time frame: Day 30
Population: All enrolled and dispensed subjects with an on-regimen follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alcon MPDS | Likert Statement: When I Use This Solution, I Can Comfortably Wear my Lenses. | 3.9 Units on a scale | Standard Deviation 0.92 |
| Renu Fresh MPS | Likert Statement: When I Use This Solution, I Can Comfortably Wear my Lenses. | 3.8 Units on a scale | Standard Deviation 1.05 |
Secondary
Likert Statement: When I Use This Solution, I Forget I am Wearing my Lenses.
As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree.
Time frame: Day 30
Population: All enrolled and dispensed subjects with an on-regimen follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alcon MPDS | Likert Statement: When I Use This Solution, I Forget I am Wearing my Lenses. | 3.2 Units on a scale | Standard Deviation 1.13 |
| Renu Fresh MPS | Likert Statement: When I Use This Solution, I Forget I am Wearing my Lenses. | 3.1 Units on a scale | Standard Deviation 1.15 |
Secondary
Likert Statement: When I Use This Solution, My Lenses Are Comfortable From Morning Until Evening.
As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree.
Time frame: Day 30
Population: All enrolled and dispensed subjects with an on-regimen follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alcon MPDS | Likert Statement: When I Use This Solution, My Lenses Are Comfortable From Morning Until Evening. | 3.3 Units on a scale | Standard Deviation 1.12 |
| Renu Fresh MPS | Likert Statement: When I Use This Solution, My Lenses Are Comfortable From Morning Until Evening. | 3.2 Units on a scale | Standard Deviation 1.21 |