An interventional study of Modified delefilcon A contact lenses and Delefilcon A contact lenses in Refractive Errors, Myopia and Hyperopia, sponsored by Alcon Research. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-13.
Sponsored by Alcon Research · Not applicable, Interventional, and Treatment
The purpose of this study is to compare visual acuity between two daily disposable contact lenses.
The expected duration of subject participation in the study is approximately 2 weeks, with 3 scheduled visits.
413 studies on the registry are indexed under Refractive Errors; 62 are open to participants now.
This study's enrollment of 62 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.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Modified delefilcon A contact lenses (MDACL) worn first, followed by delefilcon A contact lenses (DACL), as randomized. Each product worn bilaterally (in both eyes) for approximately 1 week in a daily disposable modality.
Device: Modified delefilcon A contact lenses · Device: Delefilcon A contact lenses
DACL worn first, followed by MDACL, as randomized. Each product worn bilaterally for approximately 1 week in a daily disposable modality.
Device: Modified delefilcon A contact lenses · Device: Delefilcon A contact lenses
Spherical soft daily disposable contact lens
Also known as: MDACL
Spherical soft daily disposable contact lens
Also known as: DACL
High Contrast Distance Visual Acuity (logMAR)
Distance visual acuity (VA) testing was performed using letter charts. Each row of the chart contained 5 letters, with the letters on each row progressively smaller than the row above. The subject read the letters from larger to smaller. The test terminated when the subject either misidentified a majority of letters on 1 row or progressed to the smallest row of letters. Visual acuity scoring sheets were used to record the number of letters correctly read. LogMAR VA was calculated based on the total number of letters read incorrectly as follows: LogMAR Acuity = base reading + (0.02 x number of letters missed). A lower logMAR value indicates better VA.
Time frame: Day 1 Dispense, Day 7 Follow-Up
This study was conducted at 5 investigative sites located in the United States.
| Milestone | MDACL, Then DACL | DACL, Then MDACL |
|---|---|---|
| Started | 30 | 30 |
| Completed | 30 | 29 |
| Not completed | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Milestone | MDACL, Then DACL | DACL, Then MDACL |
|---|---|---|
| Started | 30 | 29 |
| Completed | 30 | 29 |
| Not completed | 0 | 0 |
Distance visual acuity (VA) testing was performed using letter charts. Each row of the chart contained 5 letters, with the letters on each row progressively smaller than the row above. The subject read the letters from larger to smaller. The test terminated when the subject either misidentified a majority of letters on 1 row or progressed to the smallest row of letters. Visual acuity scoring sheets were used to record the number of letters correctly read. LogMAR VA was calculated based on the total number of letters read incorrectly as follows: LogMAR Acuity = base reading + (0.02 x number of letters missed). A lower logMAR value indicates better VA.
| logMar | MDACL | DACL |
|---|---|---|
| Day 1 Dispense | -0.04 ± 0.07 | -0.04 ± 0.07 |
| Day 7 Follow-Up | -0.05 ± 0.07 | -0.05 ± 0.07 |
Collected over Adverse events were collected (observed or reported) for the duration of the individual's participation in the study, approximately 2 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MDACL | 0/59 (0%) | 0/59 (0%) | 0/59 (0%) |
| DACL | 0/60 (0%) | 0/60 (0%) | 0/60 (0%) |
All subjects/eyes exposed to any study lens evaluated in this study (Safety Analysis Set).
| Age, Continuous(years) | MDACL, Then DACL | DACL, Then MDACL | Total |
|---|---|---|---|
| Mean | 32.7 ± 9.3 | 30.7 ± 8.6 | 31.7 ± 9.0 |
| Sex: Female, Male(Participants) | MDACL, Then DACL | DACL, Then MDACL | Total |
|---|---|---|---|
| Female | 23 | 24 | 47 |
| Male | 7 | 6 | 13 |
| Ethnicity (NIH/OMB)(Participants) | MDACL, Then DACL | DACL, Then MDACL | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 4 | 6 |
| Not Hispanic or Latino | 28 | 26 | 54 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | MDACL, Then DACL | DACL, Then MDACL | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 2 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 2 | 3 |
| White | 29 | 26 | 55 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | MDACL, Then DACL | DACL, Then MDACL | Total |
|---|---|---|---|
| United States | 30 | 30 | 60 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Jan 2020. 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.
Alcon Research