An interventional study of Lehfilcon A multifocal for astigmatism contact lenses and Samfilcon A multifocal for astigmatism contact lenses in Presbyopia and Astigmatism, sponsored by Alcon Research. Completed at 11 sites in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2025-12-24.
Sponsored by Alcon Research (part of Alcon) · Not applicable, Interventional, and Treatment
The purpose of this study is to evaluate on-eye clinical performance of the investigational contact lenses following 30 days of wear in the intended population.
Subjects will wear two different contact lens study products in a cross-over fashion. Each study product type will be worn for approximately 30 days. A washout period of 2-4 days will occur prior to the first wear period and between the two wear periods. Subjects will be expected to attend 5 office visits. The total duration of study participation is approximately 66 days.
336 studies on the registry are indexed under Presbyopia; 35 are open to participants now.
This study's enrollment of 95 is above the median of 61 across 276 interventional studies indexed under Presbyopia.
Browse Presbyopia studies →Alcon Research is the lead sponsor of 624 studies on the registry; 9 are open to participants now.
Of its 112 completed or terminated interventional studies of FDA-regulated products, 102 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Lehfilcon A multifocal for astigmatism contact lenses worn in Period 1, followed by samfilcon A multifocal for astigmatism contact lenses worn in Period 2, as randomized. The study lenses will be worn bilaterally (in both eyes) during typical contact lens wearing hours for at least 8 hours per day during each wear period \[30 days (-2/+1)\]. Study lenses will be removed daily for cleaning and disinfection with CLEAR CARE.
Device: Lehfilcon A multifocal for astigmatism contact lenses · Device: Samfilcon A multifocal for astigmatism contact lenses · Device: CLEAR CARE® Cleaning & Disinfecting Solution
Samfilcon A multifocal for astigmatism contact lenses worn in Period 1, followed by lehfilcon A multifocal for astigmatism contact lenses worn in Period 2, as randomized. The study lenses will be worn bilaterally (in both eyes) during typical contact lens wearing hours for at least 8 hours per day during each wear period \[30 days (-2/+1)\]. Study lenses will be removed daily for cleaning and disinfection with CLEAR CARE.
Device: Samfilcon A multifocal for astigmatism contact lenses · Device: Lehfilcon A multifocal for astigmatism contact lenses · Device: CLEAR CARE® Cleaning & Disinfecting Solution
Investigational multifocal contact lenses for astigmatism
Commercially available multifocal contact lenses for astigmatism
Also known as: ULTRA® Multifocal for Astigmatism
Hydrogen peroxide-based contact lens cleaning and disinfection system
Also known as: CLEAR CARE
Investigational multifocal contact lenses for astigmatism
Hydrogen peroxide-based contact lens cleaning and disinfection system
Also known as: CLEAR CARE
Mean Binocular Visual Acuity at Distance (4 Meters) at Day 30 With Study Lenses
Visual Acuity (VA) was assessed at a distance of 4 meters with both eyes together (binocular) under high contrast, high illumination lighting with study lenses in place. VA was measured using letter charts and recorded in the logarithm of the minimum angle of resolution (LogMAR). A LogMAR value of 0 equates to 20/20 Snellen VA (normal distance eyesight), with negative LogMAR values representing better than 20/20 VA. The LogMAR VA scale ranges from -0.30 (20/10 Snellen) to 1.00 (20/200 Snellen).
Time frame: Day 30 (-2/+1) of each wear period. A wear period was 30 days (-2/+1) according to randomization assignment.
Subjects were enrolled at 11 investigative sites.
| Milestone | LID230451, Then ULTRA MFfA | ULTRA MFfA, Then LID230451 |
|---|---|---|
| Started | 46 | 39 |
| Completed | 45 | 38 |
| Not completed | 1 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Withdrew: Screen failure | 1 | 0 |
| Milestone | LID230451, Then ULTRA MFfA | ULTRA MFfA, Then LID230451 |
|---|---|---|
| Started | 45 | 38 |
| Completed | 45 | 37 |
| Not completed | 0 | 1 |
| Withdrew: Adverse event | 0 | 1 |
| Milestone | LID230451, Then ULTRA MFfA | ULTRA MFfA, Then LID230451 |
|---|---|---|
| Started | 45 | 37 |
| Completed | 45 | 37 |
| Not completed | 0 | 0 |
Visual Acuity (VA) was assessed at a distance of 4 meters with both eyes together (binocular) under high contrast, high illumination lighting with study lenses in place. VA was measured using letter charts and recorded in the logarithm of the minimum angle of resolution (LogMAR). A LogMAR value of 0 equates to 20/20 Snellen VA (normal distance eyesight), with negative LogMAR values representing better than 20/20 VA. The LogMAR VA scale ranges from -0.30 (20/10 Snellen) to 1.00 (20/200 Snellen).
| logMAR | LID230451 | ULTRA MFfA |
|---|---|---|
| Mean Binocular Visual Acuity at Distance (4 Meters) at Day 30 With Study Lenses | -0.50 ± 0.10 | -0.08 ± 0.09 |
Collected over Adverse Events (AEs) were collected from time of consent to study exit, approximately 66 days. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects. This analysis population includes all subjects exposed to any study lenses evaluated in this study, as treated.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pretreatment | 0/85 (0%) | 0/85 (0%) | 0/85 (0%) |
| LID230451 Ocular | — | 0/166 (0%) | 0/166 (0%) |
| LID230451 Nonocular | 0/83 (0%) | 0/83 (0%) | 0/83 (0%) |
| ULTRA MFfA Ocular | — | 0/168 (0%) | 0/168 (0%) |
| ULTRA MFfA Nonocular | 0/84 (0%) | 0/84 (0%) | 0/84 (0%) |
This analysis population includes all subjects exposed to any study lenses evaluated in this study.
| Age, Continuous(years) | LID230451, Then ULTRA MFfA | ULTRA MFfA, Then LID230451 | Total |
|---|---|---|---|
| Mean | 55.8 ± 9.4 | 55.9 ± 9.4 | 55.9 ± 9.4 |
| Sex: Female, Male(Participants) | LID230451, Then ULTRA MFfA | ULTRA MFfA, Then LID230451 | Total |
|---|---|---|---|
| Female | 29 | 27 | 56 |
| Male | 17 | 12 | 29 |
| Race/Ethnicity, Customized(Participants) | LID230451, Then ULTRA MFfA | ULTRA MFfA, Then LID230451 | Total |
|---|---|---|---|
| White | 39 | 27 | 66 |
| Black or African American | 2 | 2 | 4 |
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 5 | 10 | 15 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Other | 0 | 0 | 0 |
| Region of Enrollment(participants) | LID230451, Then ULTRA MFfA | ULTRA MFfA, Then LID230451 | Total |
|---|---|---|---|
| United States | 46 | 39 | 85 |
PDFs hosted by the registry, ClinicalTrials.gov.
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