An interventional study of OPTI-FREE RepleniSH multipurpose solution and ReNu Biotrue multipurpose solution in Myopia, Astigmatism and 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 2012-11-12.
Sponsored by Alcon Research · Not applicable, Interventional, and Supportive care
The purpose of this study was to assess the comfort of OPTI-FREE RepleniSH in soft contact lens wearers.
413 studies on the registry are indexed under Astigmatism; 55 are open to participants now.
This study's enrollment of 104 is above the median of 55 across 321 interventional studies indexed under Astigmatism.
Browse Astigmatism 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.
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Exclusion Criteria:
OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days
Device: OPTI-FREE RepleniSH multipurpose solution · Device: Silicone hydrogel contact lenses
ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days
Device: ReNu Biotrue multipurpose solution · Device: Silicone hydrogel contact lenses
FDA-approved, multipurpose solution used as indicated for cleaning, rinsing, conditioning, disinfecting, and storing study contact lenses on a daily wear basis for 14 days
Also known as: OPTI-FREE® RepleniSH®
FDA-approved, multipurpose solution used as indicated for cleaning, disinfecting, daily protein removing, and storing study contact lenses on a daily wear basis for 14 days
Also known as: ReNu Biotrue™
Silicone hydrogel contact lenses per subject's habitual brand and prescription worn on a daily wear basis for 14 days, with either OPTI-FREE RepleniSH or ReNu Biotrue used for contact lens care
Change From Baseline (Day 0) in Ocular Comfort Rating at Day 14
Ocular comfort was rated by the participant on a continuous visual analog scale from 0-100, where 0=extremely uncomfortable, 50=neither comfortable nor uncomfortable, and 100=extremely comfortable. The participant marked a horizontal line across the scale at the point that best described, "how your eyes feel right now." A positive number indicates increased ocular comfort; a negative number indicates decreased ocular comfort.
Time frame: Baseline (Day 0), Day 14
| Milestone | OPTI-FREE RepleniSH | ReNu Biotrue |
|---|---|---|
| Started | 52 | 52 |
| Completed | 52 | 51 |
| Not completed | 0 | 1 |
| Withdrew: Adverse event | 0 | 1 |
Ocular comfort was rated by the participant on a continuous visual analog scale from 0-100, where 0=extremely uncomfortable, 50=neither comfortable nor uncomfortable, and 100=extremely comfortable. The participant marked a horizontal line across the scale at the point that best described, "how your eyes feel right now." A positive number indicates increased ocular comfort; a negative number indicates decreased ocular comfort.
| Units on a scale | OPTI-FREE RepleniSH | ReNu Biotrue |
|---|---|---|
| Baseline (Day 0) | 87.40 (83.82 to 90.99) | 88.79 (85.21 to 92.37) |
| Day 14 | 81.75 (78.17 to 85.33) | 83.18 (79.56 to 86.79) |
| Change from Baseline (Day 0) at Day 14 | -5.65 (-10.72 to -0.59) | -5.61 (-10.70 to -0.52) |
Collected over Adverse events were collected for the duration of the study.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| OPTI-FREE RepleniSH | — | 0/52 (0%) | 0/52 (0%) |
| ReNu Biotrue | — | 0/52 (0%) | 0/52 (0%) |
| Age Continuous(years) | OPTI-FREE RepleniSH | ReNu Biotrue | Total |
|---|---|---|---|
| Mean | 33.3 ± 10.4 | 35.4 ± 10.96 | 34.3 ± 10.71 |
| Sex: Female, Male(Participants) | OPTI-FREE RepleniSH | ReNu Biotrue | Total |
|---|---|---|---|
| Female | 14 | 10 | 24 |
| Male | 38 | 42 | 80 |
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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Alcon Research