An interventional study of FID 114675A Multi-Purpose Disinfecting Solution (MPDS) and Etafilcon A contact lens (ACUVUE® 2™) in Contact Lens Care, sponsored by Alcon Research. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-03-27.
Sponsored by Alcon Research · Not applicable, Interventional, and Supportive care
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.
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:
FID 114675A used for 7 days, per protocol-specified instructions. Silicone hydrogel or hydrogel contact lenses worn bilaterally on a daily wear basis, one brand only.
Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS) · Device: Etafilcon A contact lens (ACUVUE® 2™) · Device: Senofilcon A contact lens (ACUVUE® OASYS™) · Device: Lotrafilcon B contact lens (O2 OPTIX®) · Device: Balafilcon A contact lens (PureVision®)
Investigational solution intended for use as a cleaning, rinsing, conditioning, disinfecting, and storage solution for silicone hydrogel (SiH) contact lenses
Commercially marketed hydrogel contact lens for daily wear use
Also known as: ACUVUE® 2™
Commercially marketed silicone hydrogel contact lens for daily wear use
Also known as: ACUVUE® OASYS™
Commercially marketed silicone hydrogel contact lens for daily wear use
Also known as: O2 OPTIX®
Commercially marketed silicone hydrogel contact lens for daily wear use
Also known as: PureVision®
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
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
Participants were recruited from 6 US study centers.
| Milestone | FID 114675A |
|---|---|
| Started | 110 |
| Completed | 110 |
| Not completed | 0 |
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.
| Percentage of participants | FID 114675A |
|---|---|
| Solution-Related Corneal Staining | 0 |
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.
| Units on a scale | FID 114675A |
|---|---|
| Mean Lens Comfort | 4.4 ± 0.8 |
Collected over Adverse events were collected for the duration of the study: 24 March 2009 to 19 June 2009.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| FID 114675A | — | 0/110 (0%) | 0/110 (0%) |
| Age Continuous(years) | FID 114675A |
|---|---|
| Mean | 33.1 ± 11.1 |
| Sex: Female, Male(Participants) | FID 114675A |
|---|---|
| Female | 81 |
| Male | 29 |
No study locations are listed for this record.
This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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