An interventional study of Nelfilcon A contact lens and Narafilcon A contact lens in Myopia, sponsored by CIBA VISION. Completed. Per ClinicalTrials.gov, last updated 2012-07-10.
Sponsored by CIBA VISION · Not applicable, Interventional, and Treatment
The purpose of this trial is to evaluate the extent to which symptoms improve in symptomatic contact lens wearers when fit with one of 5 different daily disposable contact lenses.
984 studies on the registry are indexed under Myopia; 210 are open to participants now.
This study's enrollment of 128 is above the median of 80 across 783 interventional studies indexed under Myopia.
Browse Myopia 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 lens
Device: Nelfilcon A contact lens
Narafilcon A contact lens
Device: Narafilcon A contact lens
Etafilcon A contact lens
Device: Etafilcon A contact lens
Omafilcon A contact lens
Device: Omafilcon A contact lens
Hilafilcon B contact lens
Device: Hilafilcon B contact lens
Daily disposable contact lens worn in a daily wear, daily disposable mode
Daily disposable contact lens worn in a daily wear, daily disposable mode
Daily disposable contact lens worn in a daily wear, daily disposable mode
Daily disposable contact lens worn in a daily wear, daily disposable mode
Daily disposable contact lens worn in a daily wear, daily disposable mode
Lens Awareness
Lens awareness, as interpreted by the subject, was reported by the subject as a single, retrospective evaluation of 4 week's wear time. Frequency of lens awareness was measured on a 4-point scale, with 1 being never and 4 being all the time. Four-week ratings were compared to baseline ratings, and a negative difference (4-week minus baseline) represented an improvement.
Time frame: 4 weeks of wear
| Milestone | Nelfilcon A | Narafilcon A | Etafilcon A | Omafilcon A | Hilafilcon B |
|---|---|---|---|---|---|
| Started | 26 | 25 | 26 | 25 | 24 |
| Completed | 25 | 24 | 25 | 23 | 23 |
| Not completed | 1 | 1 | 1 | 2 | 1 |
| Withdrew: Failed inclusion criteria | 1 | 1 | 1 | 1 | 1 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 1 | 0 |
Lens awareness, as interpreted by the subject, was reported by the subject as a single, retrospective evaluation of 4 week's wear time. Frequency of lens awareness was measured on a 4-point scale, with 1 being never and 4 being all the time. Four-week ratings were compared to baseline ratings, and a negative difference (4-week minus baseline) represented an improvement.
| Participants | Nelfilcon A | Narafilcon A | Etafilcon A | Omafilcon A | Hilafilcon B |
|---|---|---|---|---|---|
| Lens Awareness | 16 ± 2.3 | 12 ± 2.8 | 11 ± 3.1 | 9 ± 2.5 | 13 ± 3.1 |
Collected over 8-1/2 weeks, duration of the study. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nelfilcon A | — | 0/26 (0%) | 0/26 (0%) |
| Narafilcon A | — | 0/25 (0%) | 0/25 (0%) |
| Etafilcon A | — | 0/26 (0%) | 0/26 (0%) |
| Omafilcon A | — | 0/25 (0%) | 0/25 (0%) |
| Hilafilcon B | — | 0/24 (0%) | 0/24 (0%) |
| Age Continuous(years) | Nelfilcon A | Narafilcon A | Etafilcon A | Omafilcon A | Hilafilcon B | Total |
|---|---|---|---|---|---|---|
| Mean | 29.5 ± 7.0 | 31.5 ± 11.9 | 29.9 ± 10.1 | 28.3 ± 7.7 | 30.5 ± 9.6 | 29.9 ± 9.3 |
| Sex: Female, Male(Participants) | Nelfilcon A | Narafilcon A | Etafilcon A | Omafilcon A | Hilafilcon B | Total |
|---|---|---|---|---|---|---|
| Female | 18 | 15 | 20 | 19 | 17 | 89 |
| Male | 8 | 10 | 6 | 6 | 7 | 37 |
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.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
CIBA VISION