An interventional study of Delefilcon A contact lenses and Kalifilcon A contact lenses in Refractive Errors, Ametropia and Myopia, sponsored by Alcon Research. Completed at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-08.
Sponsored by Alcon Research · Not applicable, Interventional, and Treatment
The purpose of this study is to compare the clinical performance of DAILIES TOTAL1 ( DT1) contact lenses with Infuse contact lenses.
Subjects will wear two products and be expected to attend 3 office visits. The individual duration of participation will be approximately 3 weeks, which includes 16 to 22 days of lens wear.
413 studies on the registry are indexed under Refractive Errors; 62 are open to participants now.
This study's enrollment of 112 is above 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.
Key Inclusion Criteria:
Key Exclusion Criteria:
Delefilcon A contact lenses worn first, with kalifilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 (-0/+3) days on a daily wear, daily disposable basis.
Device: Delefilcon A contact lenses · Device: Kalifilcon A contact lenses
Kalifilcon A contact lenses worn first, with delefilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 (-0/+3) days on a daily wear, daily disposable basis.
Device: Delefilcon A contact lenses · Device: Kalifilcon A contact lenses
Commercially available silicone hydrogel contact lenses used as indicated
Also known as: DAILIES TOTAL1®, DT1
Commercially available silicone hydrogel contact lenses used as indicated
Also known as: Bausch + Lomb INFUSE™, Infuse
Least Squares Mean Distance VA (logMAR) With Study Lenses
Distance visual acuity (VA) was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity.
Time frame: Day 8 (-0/+3), each study lens type
This study was conducted at 8 investigative sites in the United States.
| Milestone | DT1, Then Infuse | Infuse, Then DT1 |
|---|---|---|
| Started | 55 | 56 |
| Completed | 55 | 56 |
| Not completed | 0 | 0 |
| Milestone | DT1, Then Infuse | Infuse, Then DT1 |
|---|---|---|
| Started | 55 | 56 |
| Completed | 55 | 56 |
| Not completed | 0 | 0 |
Distance visual acuity (VA) was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity.
| logMAR | DT1 (Delefilcon A) | Infuse (Kalifilcon A) |
|---|---|---|
| Least Squares Mean Distance VA (logMAR) With Study Lenses | -0.10 ± 0.006 | -0.10 ± 0.006 |
Collected over Adverse events (AE's) were collected from time of consent to study exit, 16-22 days.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pretreatment | 0/111 (0%) | 0/111 (0%) | 0/111 (0%) |
| DT1 Ocular | 0/222 (0%) | 0/222 (0%) | 0/222 (0%) |
| DT1 Nonocular | 0/111 (0%) | 0/111 (0%) | 0/111 (0%) |
| Infuse Ocular | 0/222 (0%) | 0/222 (0%) | 0/222 (0%) |
| Infuse Nonocular | 0/111 (0%) | 0/111 (0%) | 0/111 (0%) |
Full Analysis Set (FAS): All randomized subjects exposed to any study lenses evaluated in this study
| Age, Continuous(years) | DT1, Then Infuse | Infuse, Then DT1 | Total |
|---|---|---|---|
| Mean | 33.7 ± 8.2 | 32.4 ± 7.4 | 33.0 ± 7.8 |
| Sex: Female, Male(Participants) | DT1, Then Infuse | Infuse, Then DT1 | Total |
|---|---|---|---|
| Female | 41 | 36 | 77 |
| Male | 14 | 20 | 34 |
| Ethnicity (NIH/OMB)(Participants) | DT1, Then Infuse | Infuse, Then DT1 | Total |
|---|---|---|---|
| Hispanic or Latino | 6 | 3 | 9 |
| Not Hispanic or Latino | 49 | 53 | 102 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | DT1, Then Infuse | Infuse, Then DT1 | Total |
|---|---|---|---|
| White | 50 | 52 | 102 |
| Black or African American | 4 | 3 | 7 |
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Other | 0 | 1 | 1 |
| Multi-racial | 1 | 0 | 1 |
| Region of Enrollment(participants) | DT1, Then Infuse | Infuse, Then DT1 | Total |
|---|---|---|---|
| United States | 55 | 56 | 111 |
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