Healthy Contact Lens Wearers
Conditions
Keywords
Contact Lenses, Contact Lens Care, Multi-Purpose Solution
Brief summary
The purpose of this study is to determine if Alcon MPDS is safe and effective for silicone hydrogel and soft hydrogel contact lens wearers.
Detailed description
The purpose of this study is to determine if Alcon Multi-Purpose Disinfecting Solution (MPDS) is safe and effective for silicone hydrogel and soft hydrogel contact lens wearers.
Interventions
DEVICEReNu Fresh MPS
ReNu Fresh MPS is a marketed product indicated for cleaning, removing protein deposits, rinsing, disinfecting and storage of soft contact lenses.
DEVICEAlcon MPDS
Multi-Purpose Solution intended for use with silicone hydrogel and soft contact lenses
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Silicone hydrogel or soft contact lens wearers who wear their lenses daily wear (i.e. disinfect lenses every night). * Patient must be able to read. * Vision correctable to 20/30 or better with contact lenses.
Exclusion criteria
* Sensitivity to multi-purpose solutions. * Using any topical ocular OTC or prescribed topical ocular medications. * History or current ocular infections or ocular inflammatory events. * Ocular surgery within the past year. * With a medical condition or using medications that cause ocular side effects. * Participation in any investigational study within the past 30 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Acceptance | Day 90 | Lens Moisture Subject Rated Likert Item (1-Strongly Agree to 5-Strongly Disagree) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Alcon MPDS Alcon Multi-Purpose Disinfecting Solution (MPDS) | 288 |
| ReNu Fresh Multi-Purpose Solution ReNu Fresh Multi-Purpose Solution (MPS) | 285 |
| Total | 573 |
Baseline characteristics
| Characteristic | Total | Alcon MPDS | ReNu Fresh Multi-Purpose Solution |
|---|---|---|---|
| Age, Categorical <=18 years | 31 Participants | 8 Participants | 23 Participants |
| Age, Categorical >=65 years | 6 Participants | 1 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 536 Participants | 279 Participants | 257 Participants |
| Age, Continuous | 33.9 years STANDARD_DEVIATION 11 | 34 years STANDARD_DEVIATION 10.7 | 33.9 years STANDARD_DEVIATION 11.4 |
| Region of Enrollment United States | 573 participants | 288 participants | 285 participants |
| Sex: Female, Male Female | 411 Participants | 214 Participants | 197 Participants |
| Sex: Female, Male Male | 162 Participants | 74 Participants | 88 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 288 | 0 / 285 |
| serious Total, serious adverse events | 0 / 288 | 1 / 285 |
Outcome results
Primary
Subjective Acceptance
Lens Moisture Subject Rated Likert Item (1-Strongly Agree to 5-Strongly Disagree)
Time frame: Day 90
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alcon MPDS | Subjective Acceptance | 1.9 units on a scale | Standard Deviation 0.8 |
| ReNu Fresh Multi-Purpose Solution | Subjective Acceptance | 2.1 units on a scale | Standard Deviation 1 |