An interventional study of Lehfilcon A contact lenses and Comfilcon A contact lenses in Refractive Errors, sponsored by Alcon Research. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-13.
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.
Subjects are expected to attend 5 scheduled visits. The expected duration of subject participation in the study is approximately 60 days, with approximately 30 days (± 2 days) per product.
413 studies on the registry are indexed under Refractive Errors; 62 are open to participants now.
This study's enrollment of 36 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
Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses, as randomized. Each product will be worn in both eyes on a daily wear basis at least 8 hours a day, 5 days a week, for 30 days. Lenses will be removed nightly for cleaning and disinfection.
Device: Lehfilcon A contact lenses · Device: Comfilcon A contact lenses · Device: Multi-purpose disinfection solution
Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product will be worn in both eyes on a daily wear basis at least 8 hours a day, 5 days a week, for 30 days. Lenses will be removed nightly for cleaning and disinfection.
Device: Lehfilcon A contact lenses · Device: Comfilcon A contact lenses · Device: Multi-purpose disinfection solution
Investigational silicone hydrogel contact lenses
Also known as: LID017569
Commercially available silicone hydrogel contact lenses
Also known as: Biofinity®
Solution for cleaning, disinfecting, and reconditioning silicone hydrogel contact lenses
Also known as: OPTI-FREE® RepleniSH®
Distance VA (logMAR) With Study Lenses
Visual acuity (VA) was collected for each eye individually with study lenses in place at a distance of 4 meters using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.
Time frame: Day 30 after a minimum of 6 hours of wear, each product
Subjects were enrolled at 3 investigative sites located in the US.
| Milestone | LID017569, Then Biofinity | Biofinity, Then LID017569 |
|---|---|---|
| Started | 16 | 20 |
| Completed | 16 | 20 |
| Not completed | 0 | 0 |
| Milestone | LID017569, Then Biofinity | Biofinity, Then LID017569 |
|---|---|---|
| Started | 16 | 20 |
| Completed | 16 | 20 |
| Not completed | 0 | 0 |
Visual acuity (VA) was collected for each eye individually with study lenses in place at a distance of 4 meters using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.
| logMAR | LID017569 | Biofinity |
|---|---|---|
| Distance VA (logMAR) With Study Lenses | -0.13 ± 0.06 | -0.14 ± 0.06 |
Collected over Adverse events (AE's) were collected from time of consent to study exit, approximately 60 days.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pre-treatment | 0/36 (0%) | 0/36 (0%) | 0/36 (0%) |
| LID017569 Ocular | 0/72 (0%) | 0/72 (0%) | 0/72 (0%) |
| LID017569 Nonocular/Systemic | 0/36 (0%) | 0/36 (0%) | 0/36 (0%) |
| Biofinity Ocular | 0/72 (0%) | 0/72 (0%) | 0/72 (0%) |
| Biofinity Nonocular/Systemic | 0/36 (0%) | 0/36 (0%) | 0/36 (0%) |
This analysis population includes all subjects exposed to any study lenses evaluated in this study.
| Age, Continuous(years) | Overall |
|---|---|
| Mean | 34.1 ± 5.8 |
| Sex: Female, Male(Participants) | Overall |
|---|---|
| Female | 28 |
| Male | 8 |
| Ethnicity (NIH/OMB)(Participants) | Overall |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 35 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Overall |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 34 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Overall |
|---|---|
| United States | 36 |
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Plan to share: No
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Alcon Research