An interventional study of Delefilcon A contact lens and Narafilcon A contact lens in Refractive Error and Myopia, sponsored by Alcon Research. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-06-08.
Sponsored by Alcon Research · Not applicable, Interventional, and Treatment
The purpose of this study is to compare the change from baseline in central corneal curvature at one week, between 2 silicone hydrogel lenses, in higher myopic subjects.
Participants were expected to attend 4 office visits. Visit 1 was the Screening/Enrollment visit. At Visit 2 (Baseline Visit), participants were randomized and the study lenses were trial fit. At Visit 3 (Dispense Visit), participants received study lenses for approximately 1 week of wear. Visit 4 was the Exit visit. Expected duration of participation in the study was 3 weeks.
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This study's enrollment of 19 is below the median of 80 across 783 interventional studies indexed under Myopia.
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Exclusion Criteria:
Delefilcon A contact lens randomly assigned to one eye, with narafilcon A contact lens in the fellow eye for contralateral wear. Both products worn in a daily wear, daily disposable mode approximately 8 hours a day for approximately 1 week, with spectacles worn over contact lenses if needed to provide acceptable vision.
Device: Delefilcon A contact lens · Device: Narafilcon A contact lens · Device: Spectacles
Narafilcon A contact lens randomly assigned to one eye, with delefilcon A contact lens in the fellow eye for contralateral wear. Both products worn in a daily wear, daily disposable mode approximately 8 hours a day for approximately 1 week, with spectacles worn over contact lenses if needed to provide acceptable vision.
Device: Delefilcon A contact lens · Device: Narafilcon A contact lens · Device: Spectacles
Commercially available silicone hydrogel contact lens
Also known as: DAILIES® TOTAL1®
Commercially available silicone hydrogel contact lens
Also known as: 1-DAY ACUVUE TRUEYE™
Incremental prescription worn over contact lenses if needed to provide acceptable vision
Change in Average Central Corneal Curvature From Dispense at Week 1
Corneal curvature (horizontal and vertical keratometry values on the same eye) was measured using a calibrated keratometer prior to study lens dispense (Day 1) and approximately 15 minutes after study lens removal following 8 hours of wear (Week 1). Minus values in change-from-baseline indicate corneal flattening.
Time frame: Dispense (Day 1 of lens wear), Week 1 (Day 8 of lens wear)
Number of Eyes With Change of >1.00 Diopter (D) in Spherical Equivalent of Subjective Refraction From Baseline at Week 1
Subjective manifest refraction was assessed using a phoropter or trial frame set with the subject's current prescription at Baseline (Visit 2) after a 2-day washout period and approximately 15 minutes after study lens removal following 8 hours of wear (Week 1). Spectacle over-refraction, if required, was performed. Higher myopia is indicated by larger negative values in manifest refraction.
Time frame: Baseline, Week 1 (Day 8 of lens wear)
Participants were recruited from 2 study centers located in the US and 2 study centers located in Germany.
| Milestone | DAILIES TOTAL1/TRUEYE |
|---|---|
| Started | 15 |
| Completed | 14 |
| Not completed | 1 |
| Withdrew: Adverse event | 1 |
Corneal curvature (horizontal and vertical keratometry values on the same eye) was measured using a calibrated keratometer prior to study lens dispense (Day 1) and approximately 15 minutes after study lens removal following 8 hours of wear (Week 1). Minus values in change-from-baseline indicate corneal flattening.
| diopters | DAILIES TOTAL1 | TRUEYE |
|---|---|---|
| Change in Average Central Corneal Curvature From Dispense at Week 1 | -0.44 ± 0.46 | -0.11 ± 0.26 |
Subjective manifest refraction was assessed using a phoropter or trial frame set with the subject's current prescription at Baseline (Visit 2) after a 2-day washout period and approximately 15 minutes after study lens removal following 8 hours of wear (Week 1). Spectacle over-refraction, if required, was performed. Higher myopia is indicated by larger negative values in manifest refraction.
| Eyes | DAILIES TOTAL1 | TRUEYE |
|---|---|---|
| Number of Eyes With Change of >1.00 Diopter (D) in Spherical Equivalent of Subjective Refraction From Baseline at Week 1 | 3 | 1 |
Collected over Adverse events (AEs) were collected for the duration of the study (March, 2014 - May, 2014). This analysis group includes all participants/eyes exposed to the study products. Trial-fit lenses were not considered study products.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DAILIES TOTAL1 | — | 0/15 (0%) | 4/15 (26.7%) |
| TRUEYE | — | 0/15 (0%) | 1/15 (6.7%) |
| Event | DAILIES TOTAL1 | TRUEYE |
|---|---|---|
| Foreign body sensation in eyesEye disorders | 1/15 | 0/15 |
| MetamorphopsiaEye disorders | 1/15 | 1/15 |
| MyokymiaMusculoskeletal and connective tissue disorders | 1/15 | 1/15 |
| Ocular discomfortEye disorders | 1/15 | 0/15 |
| Punctate keratitisEye disorders | 1/15 | 0/15 |
| Topography corneal abnormalInvestigations | 1/15 | 0/15 |
This analysis group includes all randomized participants.
| Age, Continuous(years) | DAILIES TOTAL1/TRUEYE |
|---|---|
| Mean | 34.2 ± 8.7 |
| Sex: Female, Male(Participants) | DAILIES TOTAL1/TRUEYE |
|---|---|
| Female | 10 |
| Male | 5 |
No study locations are listed for this record.
This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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