Refractive Error
Conditions
Keywords
Soft contact lenses, Multi-purpose solution, Corneal staining
Brief summary
The purpose of this study was to describe mean differences in corneal staining (type and area) for OPTI-FREE PureMoist Multi-Purpose Disinfecting Solution (MPDS) at Day 30 compared to Baseline (Day 0).
Interventions
DEVICEOPTI-FREE PureMoist
Commercially marketed multi-purpose contact lens solution for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses
Sponsors
Alcon Research
Study design
Allocation
NA
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 or older * Soft contact lens wear on a daily wear basis * Able to wear contact lenses for at least 8 hours * Generally healthy and have normal ocular health * Other protocol-defined inclusion criteria may apply
Exclusion criteria
* No use of additional lens cleaners * No known sensitivities to any ingredient in the test article * No history of ocular surgery/trauma within the last six months * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline (Day 0) in Average Corneal Staining Area at Day 30 | Baseline (Day 0), Day 30 | Percentage corneal staining was assessed by the investigator for each of five regions of the cornea; i.e., four quadrants plus central. The investigator instilled flourescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and yellow filter. Percentage corneal staining was recorded in increments of ten, and the percentages of the five regions were averaged together. |
| Mean Change From Baseline (Day 0) in Total Corneal Staining Type at Day 30 | Baseline (Day 0), Day 30 | Corneal staining type was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled flourescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and yellow filter. Corneal staining type was recorded on a 5-point scale for each region: 0=none; 1=micropunctate; 2=macropunctate; 3=coalesced macropunctate; 4=patch (\>/= 1 mm). The five regions were summed, for a summed total range of 0-20. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from 3 study centers in the Netherlands, 3 study centers in Sweden, and 1 study center in Australia.
Participants by arm
| Arm | Count |
|---|---|
| OPTI-FREE Multi-purpose contact lens solution used for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses, per protocol-specified regimen. | 175 |
| Total | 175 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Noncompliance | 1 |
Baseline characteristics
| Characteristic | OPTI-FREE |
|---|---|
| Age Continuous | 37.6 years STANDARD_DEVIATION 11.66 |
| Region of Enrollment Australia | 28 participants |
| Region of Enrollment Netherlands | 72 participants |
| Region of Enrollment Sweden | 75 participants |
| Sex: Female, Male Female | 111 Participants |
| Sex: Female, Male Male | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 175 |
| serious Total, serious adverse events | 0 / 175 |
Outcome results
Primary
Mean Change From Baseline (Day 0) in Average Corneal Staining Area at Day 30
Percentage corneal staining was assessed by the investigator for each of five regions of the cornea; i.e., four quadrants plus central. The investigator instilled flourescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and yellow filter. Percentage corneal staining was recorded in increments of ten, and the percentages of the five regions were averaged together.
Time frame: Baseline (Day 0), Day 30
Population: Intent to treat. All subjects who were enrolled in the study and completed at least one on-regimen study visit were evaluable for intent-to-treat analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OPTI-FREE | Mean Change From Baseline (Day 0) in Average Corneal Staining Area at Day 30 | -5.04 Percentage of corneal staining | Standard Deviation 16.119 |
Primary
Mean Change From Baseline (Day 0) in Total Corneal Staining Type at Day 30
Corneal staining type was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled flourescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and yellow filter. Corneal staining type was recorded on a 5-point scale for each region: 0=none; 1=micropunctate; 2=macropunctate; 3=coalesced macropunctate; 4=patch (\>/= 1 mm). The five regions were summed, for a summed total range of 0-20.
Time frame: Baseline (Day 0), Day 30
Population: Intent to treat. All subjects who were enrolled in the study and completed at least one on-regimen study visit were evaluable for intent-to-treat analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OPTI-FREE | Mean Change From Baseline (Day 0) in Total Corneal Staining Type at Day 30 | -0.82 Units on a scale | Standard Deviation 1.777 |