An interventional study of Lehfilcon A toric contact lenses and Comfilcon A toric contact lenses in Refractive Errors and Astigmatism, sponsored by Alcon Research. Completed at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-27.
Sponsored by Alcon Research · Not applicable, Interventional, and Treatment
The purpose of this clinical study is to assess the clinical performance of an investigational toric soft contact lens compared to a commercially available toric contact lens in a crossover dispense trial when worn in a daily wear modality for 30 days, each study lens type.
Subjects will be randomized to 1 of 2 crossover wear sequences. Subjects will be expected to attend 5 office visits, for a total individual duration of participation in the study of approximately 60 days.
413 studies on the registry are indexed under Astigmatism; 55 are open to participants now.
This study's enrollment of 76 is above the median of 55 across 321 interventional studies indexed under Astigmatism.
Browse Astigmatism 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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Key Inclusion Criteria:
Key Exclusion Criteria:
Lehfilcon A toric contact lenses worn first, with comfilcon A toric contact lenses worn second, as randomized. Each product will be worn bilaterally (in both eyes) during waking hours for at least 5 days per week, with up to 10-12 hours wear time per day over a 30-day period. CLEAR CARE will be used for nightly contact lens cleaning and disinfection.
Device: Lehfilcon A toric contact lenses · Device: Comfilcon A toric contact lenses · Device: CLEAR CARE
Comfilcon A toric contact lenses worn first, with lehfilcon A toric contact lenses worn second, as randomized. Each product will be worn bilaterally (in both eyes) during waking hours for at least 5 days per week, with up to 10-12 hours wear time per day over a 30-day period. CLEAR CARE will be used for nightly contact lens cleaning and disinfection.
Device: Lehfilcon A toric contact lenses · Device: Comfilcon A toric contact lenses · Device: CLEAR CARE
FDA-cleared silicone hydrogel toric contact lenses used as indicated
Also known as: LID205255 Toric
Commercially available silicone hydrogel toric contact lenses used as indicated
Also known as: Biofinity Toric, CooperVision® Biofinity® Toric
Hydrogen peroxide-based contact lens cleaning and disinfecting solution
Distance Visual Acuity (VA) With Study Lenses
Visual acuity (VA) was collected for each eye individually with study lenses in place 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 inferences were pre-specified for the primary effectiveness endpoint; therefore, no hypothesis testing was performed.
Time frame: Day 1 and Day 30, each wear period (approximately 30 days)
Participants were recruited from 7 investigative sites located in the United States.
| Milestone | LID205255 Toric, Then Biofinity Toric | Biofinity Toric, Then LID205255 Toric |
|---|---|---|
| Started | 36 | 38 |
| Exposed to study lenses | 35 | 38 |
| Completed | 35 | 36 |
| Not completed | 1 | 2 |
| Withdrew: Adverse event | 0 | 1 |
| Withdrew: Withdrawal by subject prior to exposure to the study lenses | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Milestone | LID205255 Toric, Then Biofinity Toric | Biofinity Toric, Then LID205255 Toric |
|---|---|---|
| Started | 35 | 36 |
| Completed | 34 | 36 |
| Not completed | 1 | 0 |
| Withdrew: Adverse event | 1 | 0 |
Visual acuity (VA) was collected for each eye individually with study lenses in place 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 inferences were pre-specified for the primary effectiveness endpoint; therefore, no hypothesis testing was performed.
| logMAR | LID205255 Toric | Biofinity Toric |
|---|---|---|
| Day 1 | -0.06 ± 0.09 | -0.07 ± 0.09 |
| Day 30 | -0.08 ± 0.09 | -0.06 ± 0.08 |
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 |
|---|---|---|---|
| Pretreatment | 0/73 (0%) | 0/73 (0%) | 0/73 (0%) |
| LID205255 Toric Ocular | 0/142 (0%) | 0/142 (0%) | 0/142 (0%) |
| LID205255 Toric Nonocular | 0/71 (0%) | 0/71 (0%) | 0/71 (0%) |
| Biofinity Toric Ocular | 0/146 (0%) | 0/146 (0%) | 0/146 (0%) |
| Biofinity Toric Nonocular | 0/73 (0%) | 0/73 (0%) | 0/73 (0%) |
This analysis population includes all randomized subjects.
| Age, Continuous(year) | LID205255 Toric, Then Biofinity Toric | Biofinity Toric, Then LID205255 Toric | Total |
|---|---|---|---|
| Mean | 32.9 ± 8.3 | 35.8 ± 10.2 | 34.4 ± 9.4 |
| Sex: Female, Male(Participants) | LID205255 Toric, Then Biofinity Toric | Biofinity Toric, Then LID205255 Toric | Total |
|---|---|---|---|
| Female | 26 | 25 | 51 |
| Male | 10 | 13 | 23 |
| Ethnicity (NIH/OMB)(Participants) | LID205255 Toric, Then Biofinity Toric | Biofinity Toric, Then LID205255 Toric | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 6 | 9 |
| Not Hispanic or Latino | 33 | 32 | 65 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | LID205255 Toric, Then Biofinity Toric | Biofinity Toric, Then LID205255 Toric | Total |
|---|---|---|---|
| White | 31 | 32 | 63 |
| Black or African American | 2 | 3 | 5 |
| Asian | 3 | 2 | 5 |
| Missing | 0 | 1 | 1 |
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