Contact Lens Care
Conditions
Keywords
Contact lenses, Disinfecting solutions
Brief summary
The purpose of this study is to clinically evaluate solution-related corneal staining with an investigational multi-purpose disinfecting solution (MPDS) in hydrogel and silicone hydrogel contact lens wearers.
Interventions
Investigational solution intended for use as a cleaning, rinsing, conditioning, disinfecting, and storage solution for silicone hydrogel (SiH) contact lenses
DEVICEEtafilcon A contact lens (ACUVUE® 2™)
Commercially marketed hydrogel contact lens for daily wear use
Commercially marketed silicone hydrogel contact lens for daily wear use
DEVICELotrafilcon B contact lens (O2 OPTIX®)
Commercially marketed silicone hydrogel contact lens for daily wear use
Commercially marketed silicone hydrogel contact lens for daily wear use
Sponsors
Alcon Research
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older. * Wear contact lenses a minimum of 8 hours per day for at least 7-10 days prior to Visit 1 (screening visit). * Vision correctable to 20/30 (Snellen) or better in each eye at distance with contact lenses at Visit 1. * Must discontinue contact lens wear for at least two consecutive days before Visit 2 (baseline visit). * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Any medical condition (systemic or ophthalmic) that may, in the opinion of the investigator, preclude safe administration of test article or safe participation in the study. * Known sensitivity or intolerance to any protocol-specified contact lens solutions, eye drops, or products containing similar ingredients (e.g., generic products). * Monocular vision (only one eye with functional vision) or fit with only one contact lens. * Use of topical ocular over-the-counter or prescribed topical ocular medication, with the exception of rewetting drops, within 7 days prior to screening visit. * Current or history of ocular infection, inflammation, disease, structural abnormality or conditions within the last 6 months that could affect study participation or may preclude safe administration of the investigational lens care solution, in the opinion of the investigator. * Any corneal surgery, cataract surgery, intraocular lens implants or glaucoma filtering surgery within the last 12 months. * Any slit-lamp finding score of 1 (or rated 3 or 4 for limbal and bulbar conjunctival injection) at screening or baseline visits. * Corneal staining area assessment ≥ 20% in any corneal region in either eye at baseline visit. * Corneal staining graded as 2 (macropunctate) or greater in any corneal region in either eye at baseline visit. * Participation in any investigational clinical study within 30 days of baseline visit. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Solution-Related Corneal Staining | Day 7 | Corneal staining was assessed by the investigator using fluorescein dye, a yellow filter, and a slit lamp. Corneal staining was graded on a continuous scale of 0% (no staining in the region) to 100% (staining covers entire region) in 1% increments for 5 corneal regions (central, nasal, temporal, inferior, and superior). Solution-related corneal staining was defined as ≥20% corneal staining area in at least 3 corneal regions of both eyes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Lens Comfort | Day 7 | Lens comfort was assessed by the participant on a 5-point Likert scale prior to any examination. The participant was instructed to select a single response to the statement, Over the previous 2-3 hours, my lenses felt comfortable, with 1 = strongly disagree, 2 = disagree, 3 = undecided, 4 = agree, and 5 = strongly agree. |
Participant flow
Recruitment details
Participants were recruited from 6 US study centers.
Pre-assignment details
110 participants with normal eyes (other than vision correction) were enrolled in the study. After the screening visit, particpants discontinued contact lens wear and wore their glasses for at least 2 days as a washout prior to the baseline/dispensing visit.
Participants by arm
| Arm | Count |
|---|---|
| FID 114675A FID 114675A used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel or hydrogel contact lenses, per protocol-specified instructions. | 110 |
| Total | 110 |
Baseline characteristics
| Characteristic | FID 114675A |
|---|---|
| Age Continuous | 33.1 years STANDARD_DEVIATION 11.1 |
| Sex: Female, Male Female | 81 Participants |
| Sex: Female, Male Male | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 110 |
| serious Total, serious adverse events | 0 / 110 |
Outcome results
Primary
Solution-Related Corneal Staining
Corneal staining was assessed by the investigator using fluorescein dye, a yellow filter, and a slit lamp. Corneal staining was graded on a continuous scale of 0% (no staining in the region) to 100% (staining covers entire region) in 1% increments for 5 corneal regions (central, nasal, temporal, inferior, and superior). Solution-related corneal staining was defined as ≥20% corneal staining area in at least 3 corneal regions of both eyes.
Time frame: Day 7
Population: Intent to treat: All participants who received regimen and had at least one on-therapy visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FID 114675A | Solution-Related Corneal Staining | 0 Percentage of participants |
Secondary
Mean Lens Comfort
Lens comfort was assessed by the participant on a 5-point Likert scale prior to any examination. The participant was instructed to select a single response to the statement, Over the previous 2-3 hours, my lenses felt comfortable, with 1 = strongly disagree, 2 = disagree, 3 = undecided, 4 = agree, and 5 = strongly agree.
Time frame: Day 7
Population: Intent to treat: All participant who received regimen and had at least one on-therapy study visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FID 114675A | Mean Lens Comfort | 4.4 Units on a scale | Standard Deviation 0.8 |