An interventional study of nelfilcon A contact lens and ocufilcon D contact lens in Myopia and Astigmatism, sponsored by CIBA VISION. Completed. Per ClinicalTrials.gov, last updated 2013-12-13.
Sponsored by CIBA VISION · Not applicable, Interventional, and Treatment
The purpose of this study is to investigate the subjective and objective performance of two daily disposable lenses for wearers with astigmatism.
413 studies on the registry are indexed under Astigmatism; 55 are open to participants now.
This study's enrollment of 220 is above the median of 55 across 321 interventional studies indexed under Astigmatism.
Browse Astigmatism studies →CIBA VISION is the lead sponsor of 51 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Nelfilcon A contact lenses worn first, with ocufilcon D contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
Device: nelfilcon A contact lens · Device: ocufilcon D contact lens
Ocufilcon D contact lenses worn first, with nelfilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
Device: nelfilcon A contact lens · Device: ocufilcon D contact lens
Commercially marketed, toric, soft contact lens for daily disposable wear
Commercially marketed, toric, soft contact lens for daily disposable wear
Overall Comfort
Overall Comfort, as interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 1-week's wear time. Overall comfort is measured on a 10-point scale, with 1 being poor and 10 being excellent.
Time frame: 1 week of wear
| Milestone | Nelfilcon A / Ocufilcon D | Ocufilcon D / Nelfilcon A |
|---|---|---|
| Started | 109 | 107 |
| Completed | 109 | 107 |
| Not completed | 0 | 0 |
| Milestone | Nelfilcon A / Ocufilcon D | Ocufilcon D / Nelfilcon A |
|---|---|---|
| Started | 109 | 107 |
| Completed | 108 | 106 |
| Not completed | 1 | 1 |
| Withdrew: Handling | 0 | 1 |
| Withdrew: Unacceptable vision | 1 | 0 |
Overall Comfort, as interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 1-week's wear time. Overall comfort is measured on a 10-point scale, with 1 being poor and 10 being excellent.
| Units on a Scale | Nelfilcon A | Ocufilcon D |
|---|---|---|
| Overall Comfort | 7.6 ± 1.9 | 7.6 ± 1.9 |
Collected over Adverse event data were collected for the duration of the trial = 87 days. Individual exposure = 2 weeks (1 week per product). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nelfilcon A | — | 0/217 (0%) | 16/217 (7.4%) |
| Ocufilcon D | — | 0/216 (0%) | 27/216 (12.5%) |
| Event | Nelfilcon A | Ocufilcon D |
|---|---|---|
| 3-grade change in symptoms (frequency and/or severity) from baselineEye disorders | 16/217 | 27/216 |
| Age, Continuous(years) | Overall Study |
|---|---|
| Mean | 33.2 ± 9.4 |
| Sex: Female, Male(Participants) | Overall Study |
|---|---|
| Female | 151 |
| Male | 66 |
No study locations are listed for this record.
This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.
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CIBA VISION