Contact Lens Moisture
Conditions
Keywords
Contact Lenses, Contact Lens Care, Multi-Purpose Solution
Brief summary
The purpose of the study is to evaluate the effect of an investigational multi-purpose disinfecting solution (MPDS) compared to a marketed multi-purpose solution on the moisture of silicone hydrogel contact lenses.
Interventions
Investigational solution intended for use as a cleaning, rinsing, reconditioning, disinfecting, and storage solution for silicone hydrogel and soft contact lenses
DEVICEReNu Fresh Lens Comfort Multi-Purpose Solution (MPS)
Commercially marketed prodouct indicated for cleaning, removing protein deposits, rinsing, disinfecting, and storing soft contact lenses
Commercially marketed silicone hydrogel contact lenses per habitual prescription for daily wear use, at least 8 hours/day. New pair dispensed at Day 0 (Baseline Visit) and at the conclusion of Day 1 (Visit 2).
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older. * Wears silicone hydrogel contact lenses on a daily wear basis i.e. disinfects lenses every night). * Has successfully worn contact lenses for 5 days, 8 hours per day, prior to baseline visit. * Vision is correctable to 20/30 or better in each eye at distance with study lenses at baseline visit. * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Known sensitivity or intolerance to contact lens multi-purpose solutions. * Use of any topical ocular OTC or prescribed topical ocular medications. * History or current ocular infections or ocular inflammatory events. * Ocular surgery within the past year. * Medical condition or use of medication 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 |
|---|---|---|
| Mean Ex-Vivo Advancing Contact Angle | Day 1, 8 hours | Study lens was removed from the eye according to protocol-specified procedures. The OCA15 (Optical Contact Angle) Instrument was used to observe, record, and calculate contact angle measurements. The wetting angle measurement was recorded in degrees (0-180), and a lower wetting angle measurement indicates a more wettable lens. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from 1 US study center.
Participants by arm
| Arm | Count |
|---|---|
| FID 114675A Multi-purpose disinfecting solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses | 35 |
| ReNu MultiPlus Multi-purpose solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses | 33 |
| Total | 68 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Torn Study Lens | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | FID 114675A | ReNu MultiPlus | Total |
|---|---|---|---|
| Age Continuous | 43.9 years STANDARD_DEVIATION 9.2 | 42.8 years STANDARD_DEVIATION 11.2 | 43.4 years STANDARD_DEVIATION 10.2 |
| Region of Enrollment United States | 35 participants | 33 participants | 68 participants |
| Sex: Female, Male Female | 23 Participants | 22 Participants | 45 Participants |
| Sex: Female, Male Male | 12 Participants | 11 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 / 35 | 0 / 33 |
| serious Total, serious adverse events | 0 / 35 | 0 / 33 |
Outcome results
Primary
Mean Ex-Vivo Advancing Contact Angle
Study lens was removed from the eye according to protocol-specified procedures. The OCA15 (Optical Contact Angle) Instrument was used to observe, record, and calculate contact angle measurements. The wetting angle measurement was recorded in degrees (0-180), and a lower wetting angle measurement indicates a more wettable lens.
Time frame: Day 1, 8 hours
Population: Intent to Treat.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FID 114675A | Mean Ex-Vivo Advancing Contact Angle | 56.7 Degrees | Standard Deviation 21.2 |
| ReNu MultiPlus | Mean Ex-Vivo Advancing Contact Angle | 59.2 Degrees | Standard Deviation 23.7 |
Primary
Mean Ex-Vivo Advancing Contact Angle
Study lens was removed from the eye according to protocol-specified procedures. The OCA15 (Optical Contact Angle) Instrument was used to observe, record, and calculate contact angle measurements. The wetting angle measurement was recorded in degrees (0-180), and a lower wetting angle measurement indicates a more wettable lens.
Time frame: Day 8, 16 hours
Population: Intent to treat.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FID 114675A | Mean Ex-Vivo Advancing Contact Angle | 59.5 Degrees | Standard Deviation 21.2 |
| ReNu MultiPlus | Mean Ex-Vivo Advancing Contact Angle | 63.4 Degrees | Standard Deviation 17.5 |