An interventional study of OPTI-FREE PureMoist in Refractive Error, sponsored by Alcon Research. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-10-10.
Sponsored by Alcon Research · Not applicable, Interventional, and Supportive care
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).
413 studies on the registry are indexed under Refractive Errors; 62 are open to participants now.
This study's enrollment of 175 is above the median of 82 across 296 interventional studies indexed under Refractive Errors.
Browse Refractive Errors studies →Alcon Research is the lead sponsor of 608 studies on the registry; 9 are open to participants now.
Of its 109 completed or terminated interventional studies of FDA-regulated products, 99 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
OPTI-FREE PureMoist multi-purpose contact lens solution used for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses, per protocol-specified regimen
Device: OPTI-FREE PureMoist
Commercially marketed multi-purpose contact lens solution for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses
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
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
Participants were recruited from 3 study centers in the Netherlands, 3 study centers in Sweden, and 1 study center in Australia.
| Milestone | OPTI-FREE |
|---|---|
| Started | 175 |
| Completed | 171 |
| Not completed | 4 |
| Withdrew: Adverse event | 2 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Noncompliance | 1 |
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.
| Percentage of corneal staining | OPTI-FREE |
|---|---|
| Mean Change From Baseline (Day 0) in Average Corneal Staining Area at Day 30 | -5.04 ± 16.119 |
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.
| Units on a scale | OPTI-FREE |
|---|---|
| Mean Change From Baseline (Day 0) in Total Corneal Staining Type at Day 30 | -0.82 ± 1.777 |
Collected over Adverse events were collected for the duration of the study: 3 months, 2 weeks, 2 days.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| OPTI-FREE | — | 0/175 (0%) | 0/175 (0%) |
| Age Continuous(years) | OPTI-FREE |
|---|---|
| Mean | 37.6 ± 11.66 |
| Sex: Female, Male(Participants) | OPTI-FREE |
|---|---|
| Female | 111 |
| Male | 64 |
| Region of Enrollment(participants) | OPTI-FREE |
|---|---|
| Netherlands | 72 |
| Sweden | 75 |
| Australia | 28 |
This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.
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