An interventional study of verofilcon A contact lenses and senofilcon A contact lenses in Refractive Error, sponsored by Alcon Research. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-22.
Sponsored by Alcon Research · Not applicable, Interventional, and Treatment
The purpose of this study is to obtain on-eye performance data to inform contact lens product development and to further evaluate product performance in the intended population.
The expected duration of subject participation in the study is approximately 20 days with 3 scheduled visits. Each subject will evaluate the test contact lenses compared to 1 of 3 commercially available contact lenses.
Exclusion Criteria:
Verofilcon A contact lenses and senofilcon A contact lenses worn in both eyes, each product, for 1 week on a daily wear basis, as randomized
Device: verofilcon A contact lenses · Device: senofilcon A contact lenses
Verofilcon A contact lenses and stenfilcon A contact lenses worn in both eyes, each product, for 1 week on a daily disposable basis, as randomized
Device: verofilcon A contact lenses · Device: stenfilcon A contact lenses
Verofilcon A contact lenses and etafilcon A contact lenses worn in both eyes, each product, for 1 week on a daily disposable basis, as randomized
Device: verofilcon A contact lenses · Device: etafilcon A contact lenses
Investigational spherical silicone hydrogel contact lenses for daily disposable wear
Also known as: DDT2
Commercially available spherical silicone hydrogel contact lenses for daily disposable wear
Also known as: ACUVUE OASYS® 1-Day with HydraLuxe™ Technology, Oasys 1-Day
Commercially available spherical silicone hydrogel contact lenses for daily disposable wear
Also known as: MyDay®, MyDay
Commercially available spherical silicone hydrogel contact lenses for daily disposable wear
Also known as: 1-Day ACUVUE® MOIST, Moist
Overall Quality of Vision
Overall quality of vision was collected binocularly and rated on a 10-point scale with 1 = poor to 10 = excellent. Subjects were asked "Thinking back over the last week, please rate our study lenses. Rate eyes together." No formal hypotheses was conducted; hence no inferential testing was performed.
Time frame: Day 8, each product
Subjects were recruited from 3 investigational sites located in the United States.
| Milestone | DD T2/Oasys 1-Day (Sequence 1) | Oasys 1-Day/DD T2 (Sequence 2) | DD T2/MyDay (Sequence 3) | MyDay/DD T2 (Sequence 4) | DD T2/Moist (Sequence 5) | Moist/DD T2 (Sequence 6) |
|---|---|---|---|---|---|---|
| Started | 11 | 11 | 11 | 11 | 11 | 11 |
| Completed | 11 | 11 | 11 | 11 | 11 | 11 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | DD T2/Oasys 1-Day (Sequence 1) | Oasys 1-Day/DD T2 (Sequence 2) | DD T2/MyDay (Sequence 3) | MyDay/DD T2 (Sequence 4) | DD T2/Moist (Sequence 5) | Moist/DD T2 (Sequence 6) |
|---|---|---|---|---|---|---|
| Started | 11 | 11 | 11 | 11 | 11 | 11 |
| Completed | 11 | 11 | 11 | 11 | 11 | 11 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
Overall quality of vision was collected binocularly and rated on a 10-point scale with 1 = poor to 10 = excellent. Subjects were asked "Thinking back over the last week, please rate our study lenses. Rate eyes together." No formal hypotheses was conducted; hence no inferential testing was performed.
| units on a scale | DD T2 (Sequence 1 and 2) | Oasys 1-Day (Sequence 1 and 2) | DD T2 (Sequence 3 and 4) | MyDay (Sequence 3 and 4) | DD T2 (Sequence 5 and 6) | Moist (Sequence 5 and 6) |
|---|---|---|---|---|---|---|
| Overall Quality of Vision | 8.5 ± 1.4 | 9.2 ± 1.3 | 8.8 ± 1.8 | 9.4 ± 0.8 | 9.2 ± 1.1 | 8.8 ± 1.7 |
Collected over Dispense through study completion, an average of 2 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DD T2 (Sequence 1 and 2) | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) |
| Oasys 1- Day (Sequence 1 and 2) | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) |
| DD T2 (Sequence 3 and 4) | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) |
| MyDay (Sequence 3 and 4) | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) |
| DD T2 (Sequence 5 and 6) | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) |
| Moist (Sequence 5 and 6) | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) |
This analysis population includes all subjects/eyes exposed to any study lenses evaluated in this study (Safety Analysis Set).
| Age, Continuous(years) | Overall |
|---|---|
| Mean | 32.9 ± 9.1 |
| Sex: Female, Male(Participants) | Overall |
|---|---|
| Female | 46 |
| Male | 20 |
| Race/Ethnicity, Customized(Participants) | Overall |
|---|---|
| White | 56 |
| Black or African American | 6 |
| American Indian or Alaska Native | 0 |
| Asian | 4 |
| Native Hawaiian or Other Pacific Islander | 0 |
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 2019. 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