An interventional study of Serafilcon A multifocal contact lenses and Senofilcon A multifocal contact lenses in Presbyopia, sponsored by Alcon Research. Completed at 8 sites in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2025-10-09.
Sponsored by Alcon Research (part of Alcon) · Not applicable, Interventional, and Treatment
The purpose of this study is to evaluate the on-eye multifocal clinical performance of investigational LID233309 contact lenses and Oasys multifocal (MF) contact lenses in a daily wear dispensing trial.
Subjects will wear two different contact lens study products in a cross-over fashion. Each study product type will be worn for approximately 14 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 7 office visits. The total duration of study participation is approximately 40 days with approximately 28 days of lens wear.
336 studies on the registry are indexed under Presbyopia; 35 are open to participants now.
This study's enrollment of 106 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:
Serafilcon A multifocal contact lenses worn in Period 1, followed by senofilcon A multifocal contact lenses worn in Period 2, as randomized. The study lenses will be worn in a daily wear mode in both eyes (bilaterally) during waking hours for at least 10 hours per day. Each wear period is 14 days (-0/+2). CLEAR CARE will be used for daily cleaning and disinfection.
Device: Serafilcon A multifocal contact lenses · Device: Senofilcon A multifocal contact lenses · Device: CLEAR CARE® Cleaning & Disinfecting Solution
Senofilcon A multifocal contact lenses worn in Period 1, followed by serafilcon A multifocal contact lenses worn in Period 2, as randomized. The study lenses will be worn in a daily wear mode in both eyes (bilaterally) during waking hours for at least 10 hours per day. Each wear period is 14 days (-0/+2). CLEAR CARE will be used for daily cleaning and disinfection.
Device: Serafilcon A multifocal contact lenses · Device: Senofilcon A multifocal contact lenses · Device: CLEAR CARE® Cleaning & Disinfecting Solution
Investigational multifocal soft contact lenses
Also known as: LID233309
Commercially available multifocal soft contact lenses
Also known as: ACUVUE® OASYS MULTIFOCAL with PUPIL OPTIMIZED DESIGN, Oasys MF
Hydrogen peroxide-based contact lens cleaning and disinfection system
Also known as: CLEAR CARE
Mean Binocular Visual Acuity at Distance (4 Meters) at Week 1
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). No hypothesis testing was pre-specified for this endpoint.
Time frame: Week 1 (Day 7 -0/+1 days) of each wear period. A wear period was 14 days (-0/+2 days) according to randomization assignment.
Subjects were enrolled at 8 investigative sites.
| Milestone | LID233309, Then Oasys MF | Oasys MF, Then LID233309 |
|---|---|---|
| Started | 53 | 51 |
| Completed | 48 | 47 |
| Not completed | 5 | 4 |
| Withdrew: Protocol violation | 4 | 3 |
| Withdrew: As per sponsor guidance | 1 | 1 |
| Milestone | LID233309, Then Oasys MF | Oasys MF, Then LID233309 |
|---|---|---|
| Started | 48 | 47 |
| Completed | 48 | 47 |
| 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). No hypothesis testing was pre-specified for this endpoint.
| logMAR | LID233309 | Oasys MF |
|---|---|---|
| Mean Binocular Visual Acuity at Distance (4 Meters) at Week 1 | -0.08 ± 0.09 | -0.08 ± 0.09 |
Collected over Adverse Events (AEs) were collected from time of consent to study exit, approximately 40 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 | 0/104 (0%) | 0/104 (0%) | 0/104 (0%) |
| LID233309 Ocular | — | 0/200 (0%) | 0/200 (0%) |
| LID233309 Nonocular | 0/100 (0%) | 0/100 (0%) | 0/100 (0%) |
| Oasys MF Ocular | — | 0/198 (0%) | 0/198 (0%) |
| Oasys MF Nonocular | 0/99 (0%) | 0/99 (0%) | 0/99 (0%) |
This analysis population includes all subjects exposed to any study lenses evaluated in this study.
| Age, Continuous(years) | LID233309, Then Oasys MF | Oasys MF, Then LID233309 | Total |
|---|---|---|---|
| Mean | 52.1 ± 7.0 | 53.5 ± 6.7 | 52.8 ± 6.9 |
| Sex: Female, Male(Participants) | LID233309, Then Oasys MF | Oasys MF, Then LID233309 | Total |
|---|---|---|---|
| Female | 35 | 37 | 72 |
| Male | 18 | 14 | 32 |
| Race/Ethnicity, Customized(participants) | LID233309, Then Oasys MF | Oasys MF, Then LID233309 | Total |
|---|---|---|---|
| White | 37 | 37 | 74 |
| Black or African American | 2 | 1 | 3 |
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 14 | 11 | 25 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Other | 0 | 1 | 1 |
| Multi-Racial | 0 | 1 | 1 |
| Race/Ethnicity, Customized(participants) | LID233309, Then Oasys MF | Oasys MF, Then LID233309 | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 2 | 5 |
| Not Hispanic or Latino | 50 | 49 | 99 |
| Region of Enrollment(participants) | LID233309, Then Oasys MF | Oasys MF, Then LID233309 | Total |
|---|---|---|---|
| United States | 53 | 51 | 104 |
PDFs hosted by the registry, ClinicalTrials.gov.
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