Contact Lens Care
Conditions
Keywords
Contact lenses, Disinfecting solutions
Brief summary
The purpose of this study is to clinically evaluate an investigational multi-purpose disinfecting solution (MPDS) compared to a commercial MPDS with respect to wettability of silicone hydrogel contact lenses.
Interventions
Investigational solution intended for use as a cleaning, rinsing, conditioning, disinfecting, and storage solution for silicone hydrogel (SiH) contact lenses.
DEVICERepleniSH Multi-Purpose Disinfecting Solution (MPDS) (OPTI-FREE® RepleniSH®)
Commercially marketed solution intended for use as a cleaning, conditioning, rinsing, disinfecting, and storage solution for all silicone hydrogel and soft (hydrophilic) contact lenses.
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
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older. * Must be successfully wearing assigned study lens brand (either ACUVUE® OASYS™ or PureVision® contact lenses) for at least 7-10 days, minimum 8 hours a day, prior to Visit 1 (screening). * Vision correctable to 20/30 (Snellen) or better in each eye at distance with study lenses at Visit 1 (screening). * Must have discontinued contact lens wear for at least two consecutive days before Visit 2 (baseline). * Other protocol-defined 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 screening or 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 |
|---|---|---|
| Mean Ex-Vivo Wetting Angle | Day 7, Hour 14 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Lens Comfort | Day 7, Hour 14 | 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, My lenses feel comfortable right now, with 1 = strongly disagree, 2 = disagree, 3 = undecided, 4 = agree, and 5 = strongly agree. |
| Percentage of Participants With Solution-Related Corneal Staining | Day 7, Hour 14 | 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 and is reported as a percentage of total participants. |
Participant flow
Recruitment details
Participants were recruited from one US study center.
Pre-assignment details
40 participants with normal eyes (other than vision correction) were enrolled in the trial. After the screening visit, participants discontinued contact lens wear and wore their glasses for at least 2 days as a washout prior to Period 1. A similar washout occurred prior to Period 2. Cross-over study design.
Participants by arm
| Arm | Count |
|---|---|
| FID 114675A / RepleniSH FID 114675A in Period 1; RepleniSH in Period 2. Each solution was used for 7 days, per protocol-specified instructions. Contact lenses worn bilaterally on a daily wear basis, with a new pair dispensed at the beginning of each period. | 20 |
| RepleniSH / FID 114675A RepleniSH in Period 1; FID 114675A in Period 2. Each solution was used for 7 days, per protocol-specified instructions. Contact lenses worn bilaterally on a daily wear basis, with a new pair dispensed at the beginning of each period. | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | FID 114675A / RepleniSH | RepleniSH / FID 114675A | Total |
|---|---|---|---|
| Age Continuous | 42.9 years STANDARD_DEVIATION 10.1 | 42.4 years STANDARD_DEVIATION 10 | 42.6 years STANDARD_DEVIATION 10 |
| Sex: Female, Male Female | 12 Participants | 11 Participants | 23 Participants |
| Sex: Female, Male Male | 8 Participants | 9 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
Primary
Mean Ex-Vivo Wetting 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 7, Hour 14
Population: Intent to treat: All participants who received regimen and had at least one on-therapy visit. Cross-over study design.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FID 114675A | Mean Ex-Vivo Wetting Angle | 52.1 Degrees | Standard Deviation 32.7 |
| RepleniSH | Mean Ex-Vivo Wetting Angle | 59.6 Degrees | Standard Deviation 38.1 |
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, My lenses feel comfortable right now, with 1 = strongly disagree, 2 = disagree, 3 = undecided, 4 = agree, and 5 = strongly agree.
Time frame: Day 7, Hour 14
Population: Intent to treat: All participants who received regimen and had at least one on-therapy visit. Cross-over study design.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FID 114675A | Mean Lens Comfort | 4.1 Units on a scale | Standard Deviation 0.9 |
| RepleniSH | Mean Lens Comfort | 3.8 Units on a scale | Standard Deviation 0.9 |
Secondary
Percentage of Participants With 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 and is reported as a percentage of total participants.
Time frame: Day 7, Hour 14
Population: Intent to treat: All participants who received regimen and had at least one on-therapy visit. Cross-over study design.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FID 114675A | Percentage of Participants With Solution-Related Corneal Staining | 0 Percentage of participants |
| RepleniSH | Percentage of Participants With Solution-Related Corneal Staining | 0 Percentage of participants |