Contact Lens Wettability
Conditions
Keywords
Contact Lenses, Contact Lens Care, Multi-Purpose Solution Wettability, Myopia
Brief summary
The purpose of this study is to evaluate lens wettability of contact lenses when used with an investigational multi-purpose disinfecting solution.
Interventions
Investigational multi-purpose disinfecting solution intended for use as a cleaning, reconditioning, rinsing, disinfecting, and storage solution for silicone hydrogel and soft contact lenses.
DEVICESoft contact lens
Soft hydrogel or silicone hydrogel contact lens matching subject's pre-study lens, including parameters, worn 16 hours on day of dispense.
DEVICEBlister pack solution
Commercially approved storage solution as found in the contact lens blister pack.
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or age or older with normal eyes, other than correction for refractive error. * At least 5 days successful daily wear (minimum 8 hours per day) of PureVision®, Acuvue® Oasys™, or Acuvue® 2 contact lenses prior to Visit 1 * Vision correctable to 20/30 (Snellen) or better in each eye at distance with lenses at Visit 1 (Day 0 - Baseline). * Grade 0 or Grade 1 wettability in both eyes after at least 15 minutes of lens wear at Visit 1 (Day 0 - Baseline). * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the test articles or affect the results of the study. * Need to wear contact lenses on an extended wear basis (i.e., overnight) during the study. * Use of products other than a multi-purpose solution or hydrogen peroxide solution, including daily and enzyme cleaners and saline rinses, for lens care at least 7 days prior to Visit 1 (Day 0 - Baseline). * Use of over-the-counter (OTC) or prescribed topical ocular medications within 7 days prior to Visit 1. Use of lens rewetting drops is acceptable. * History or current ocular infections or ocular inflammatory events. * Ocular surgery within the past year. * Participation in any investigational study within the past 30 days. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lens Wettability | 16 hours | As assessed by the investigator during slit-lamp exam and rated on a 0-4 scale, with 0 = a smooth uniformly reflecting wettable surface; 1 = a coarse hazy wettable surface which seems resolved momentarily with each blink and becomes exacerbated with staring; 2 = one stable dry (non-wetting) area of some magnitude; 3 = more than one stable dry (non-wetting) area of some magnitude; 4 = non-wettable lens surface of severe magnitude. Lenses with a Grade 0 or 1 were rated as wettable and reported as a percentage of total lenses evaluated. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| FID 114675A Contact lens soaked overnight in an investigational multi-purpose disinfecting solution randomly assigned to right eye, with contact lens removed directly from the blister pack assigned to left eye for contralateral wear. | 34 |
| Blister Pack Contact lens removed directly from the blister pack randomly assigned to right eye, with contact lens soaked overnight in an investigational multi-purpose disinfecting solution assigned to left eye for contralateral wear. | 32 |
| Total | 66 |
Baseline characteristics
| Characteristic | FID 114675A | Blister Pack | Total |
|---|---|---|---|
| Age Continuous | 36.6 years STANDARD_DEVIATION 10.76 | 37.3 years STANDARD_DEVIATION 12.34 | 36.9 years STANDARD_DEVIATION 11.47 |
| Sex: Female, Male Female | 25 Participants | 22 Participants | 47 Participants |
| Sex: Female, Male Male | 9 Participants | 10 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 66 | 0 / 66 |
| serious Total, serious adverse events | 0 / 66 | 0 / 66 |
Outcome results
Primary
Lens Wettability
As assessed by the investigator during slit-lamp exam and rated on a 0-4 scale, with 0 = a smooth uniformly reflecting wettable surface; 1 = a coarse hazy wettable surface which seems resolved momentarily with each blink and becomes exacerbated with staring; 2 = one stable dry (non-wetting) area of some magnitude; 3 = more than one stable dry (non-wetting) area of some magnitude; 4 = non-wettable lens surface of severe magnitude. Lenses with a Grade 0 or 1 were rated as wettable and reported as a percentage of total lenses evaluated.
Time frame: 16 hours
Population: Intent to treat. All subject-eyes that received contact lenses pre-soaked per treatment regimen and completed Visit 2 (Day 1 - Exit at 16 hours) were included in the ITT data set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FID 114675A | Lens Wettability | 95.5 percentage of lenses |
| Blister Pack | Lens Wettability | 97.0 percentage of lenses |