An interventional study of Delefilcon A contact lens and Etafilcon A contact lens in Myopia, sponsored by CIBA VISION. Completed. Per ClinicalTrials.gov, last updated 2012-08-03.
Sponsored by CIBA VISION · Not applicable, Interventional, and Treatment
The purpose of this trial was to compare the performance of an investigational daily disposable contact lens to a commercially available daily disposable contact lens.
984 studies on the registry are indexed under Myopia; 210 are open to participants now.
This study's enrollment of 40 is below 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:
Delefilcon A contact lenses worn first, with etafilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
Device: Delefilcon A contact lens · Device: Etafilcon A contact lens
Etafilcon A contact lenses worn first, with delefilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
Device: Delefilcon A contact lens · Device: Etafilcon A contact lens
Investigational, silicone hydrogel, single vision, soft contact lens for daily disposable wear
Also known as: DAILIES® Total1®
Commercially marketed, HEMA-based, single vision, soft contact lens for daily disposable wear
Also known as: 1-DAY ACUVUE® MOIST™
Corrected Distance Monocular Visual Measurement Reported as Visual Acuity (VA)
As tested for each eye individually while wearing study lenses. VA was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal distance eyesight. Positive logMAR values indicated poorer vision, and negative values denoted better visual acuity.
Time frame: 1 week of wear, replacing lenses daily
Overall Comfort
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.
Time frame: 1 week of wear, replacing lenses daily
Overall Vision Quality
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision quality was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.
Time frame: 1 week of wear, replacing lenses daily
Overall Handling
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall handling was evaluated binocularly and rated on a 10-point scale, with 1 being difficult and 10 being easy.
Time frame: 1 week of wear, replacing lenses daily
Overall Lens Fit
As assessed for each eye individually by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit is reported on a 5-point scale, with 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight.
Time frame: 1 week of wear, replacing lenses daily
Participants were recruited from 4 US private practices.
| Milestone | Delefilcon A / Etafilcon A | Etafilcon A / Delefilcon A |
|---|---|---|
| Started | 20 | 20 |
| Completed | 20 | 20 |
| Not completed | 0 | 0 |
| Milestone | Delefilcon A / Etafilcon A | Etafilcon A / Delefilcon A |
|---|---|---|
| Started | 20 | 20 |
| Completed | 20 | 20 |
| Not completed | 0 | 0 |
As tested for each eye individually while wearing study lenses. VA was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal distance eyesight. Positive logMAR values indicated poorer vision, and negative values denoted better visual acuity.
| logMAR | Delefilcon A | Etafilcon A |
|---|---|---|
| Corrected Distance Monocular Visual Measurement Reported as Visual Acuity (VA) | -0.02 ± 0.06 | -0.02 ± 0.05 |
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.
| Units on a scale | Delefilcon A | Etafilcon A |
|---|---|---|
| Overall Comfort | 9.0 ± 1.5 | 8.1 ± 1.6 |
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision quality was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.
| Units on a scale | Delefilcon A | Etafilcon A |
|---|---|---|
| Overall Vision Quality | 9.4 ± 1.0 | 8.9 ± 1.2 |
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall handling was evaluated binocularly and rated on a 10-point scale, with 1 being difficult and 10 being easy.
| Units on a scale | Delefilcon A | Etafilcon A |
|---|---|---|
| Overall Handling | 8.5 ± 1.9 | 8.6 ± 1.4 |
As assessed for each eye individually by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit is reported on a 5-point scale, with 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight.
| Units on a scale | Delefilcon A | Etafilcon A |
|---|---|---|
| Overall Lens Fit | -0.1 ± 0.5 | 0.1 ± 0.3 |
Collected over Adverse events were collected for the duration of the trial: 1 month.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Delefilcon A | — | 0/40 (0%) | 0/40 (0%) |
| Etafilcon A | — | 0/40 (0%) | 0/40 (0%) |
| Age Continuous(years) | Overall |
|---|---|
| Mean | 32.7 ± 9.5 |
| Sex: Female, Male(Participants) | Overall |
|---|---|
| Female | 29 |
| Male | 11 |
| Region of Enrollment(participants) | Overall |
|---|---|
| United States | 40 |
No study locations are listed for this record.
This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.
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CIBA VISION