An interventional study of Delefilcon A contact lenses in Refractive Error, sponsored by Alcon Research. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-05-14.
Sponsored by Alcon Research · Not applicable and Interventional
The primary objective of the study is to demonstrate that the lubricity of DAILIES TOTAL1® (DT1) lenses after 16 hours of wear is equivalent to the lubricity of unworn DT1 lenses.
In this study, participants wore study lenses for 2 specified time periods (16 hours and 15 minutes, treatment sequence randomized) following which lenses were collected for ex vivo lubricity analysis. The ex vivo lubricity analysis was evaluated under a separate non-clinical protocol.
413 studies on the registry are indexed under Refractive Errors; 62 are open to participants now.
This study's enrollment of 15 is below the median of 82 across 296 interventional studies indexed under Refractive Errors.
Browse Refractive Errors studies →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.
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Exclusion Criteria:
Delefilcon A contact lenses worn bilaterally (in both eyes) for 16 waking hours (1 day) in Period 1, followed by 15 minutes in Period 2. A fresh pair of lenses was dispensed for Period 2.
Device: Delefilcon A contact lenses
Delefilcon A contact lenses worn bilaterally for 15 minutes in Period 1, followed by 16 waking hours (1 day) in Period 2. A fresh pair of lenses was dispensed for Period 2.
Device: Delefilcon A contact lenses
Silicone hydrogel contact lenses
Also known as: DAILIES TOTAL1®
Average Coefficient of Friction (CF) at 16 Hours Compared to Unworn
Worn contact lenses were removed from the participant's eye. The CF was calculated and compared to the CF for unworn contact lenses. A lower CF may indicate higher contact lens lubricity. The ex-vivo lubricity was carried out on one lens (one eye) only.
Time frame: Day 1 (for each period), 16 hours
Average Coefficient of Friction at 15 Minutes
Worn contact lenses were removed from the participant's eye and the CF was calculated. A lower CF may indicate higher contact lens lubricity. The ex-vivo lubricity was carried out on one lens (one eye) only.
Time frame: Day 1 (for each period), 15 minutes
Participants were recruited from 1 study center located in the US.
| Milestone | 16hr/15min | 15min/16hr |
|---|---|---|
| Started | 7 | 8 |
| Completed | 7 | 8 |
| Not completed | 0 | 0 |
| Milestone | 16hr/15min | 15min/16hr |
|---|---|---|
| Started | 7 | 8 |
| Completed | 7 | 7 |
| Not completed | 0 | 1 |
| Withdrew: Adverse event | 0 | 1 |
Worn contact lenses were removed from the participant's eye. The CF was calculated and compared to the CF for unworn contact lenses. A lower CF may indicate higher contact lens lubricity. The ex-vivo lubricity was carried out on one lens (one eye) only.
| unitless | 16 Hours | Unworn |
|---|---|---|
| Average Coefficient of Friction (CF) at 16 Hours Compared to Unworn | 0.0394 ± 0.0015 | 0.0396 ± 0.0027 |
Worn contact lenses were removed from the participant's eye and the CF was calculated. A lower CF may indicate higher contact lens lubricity. The ex-vivo lubricity was carried out on one lens (one eye) only.
| unitless | 15 Minutes |
|---|---|
| Average Coefficient of Friction at 15 Minutes | 0.0392 ± 0.0017 |
Collected over Adverse events (AEs) were collected for the duration of the study (March 2014 - April 2014). This analysis population includes all participants exposed to the investigational product, based on treatment-specific exposure.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DAILIES TOTAL1 | — | 0/15 (0%) | 2/15 (13.3%) |
| Event | DAILIES TOTAL1 |
|---|---|
| Corneal infiltratesEye disorders | 1/15 |
| Ocular discomfortEye disorders | 1/15 |
This analysis population includes all randomized participants.
| Age, Continuous(years) | Overall |
|---|---|
| Mean | 44.9 ± 10.91 |
| Sex: Female, Male(Participants) | Overall |
|---|---|
| Female | 9 |
| Male | 6 |
No study locations are listed for this record.
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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