Astigmatism, Presbyopia
Conditions
Keywords
Myopia, Hyperopia, Multifocal, Toric
Brief summary
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.
Detailed description
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.
Interventions
DEVICELehfilcon A multifocal for astigmatism contact lenses
Investigational multifocal contact lenses for astigmatism
DEVICESamfilcon A multifocal for astigmatism contact lenses
Commercially available multifocal contact lenses for astigmatism
Hydrogen peroxide-based contact lens cleaning and disinfection system
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Habitual wearer of biweekly/monthly replacement soft multifocal or multifocal toric contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months; * Manifest cylinder equal to or greater than 0.75 diopter (D) in each eye at Screening; * Willing to not use readers while wearing study contact lenses for duration of the study; * Other protocol-defined inclusion criteria may apply. Key
Exclusion criteria
* Use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear; * Wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment; * Monovision contact lens wearers and wearers of contact lens in one eye only; * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Binocular Visual Acuity at Distance (4 Meters) at Day 30 With Study Lenses | Day 30 (-2/+1) of each wear period. A wear period was 30 days (-2/+1) according to randomization assignment. | 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). |
Countries
United States
Participant flow
Recruitment details
Subjects were enrolled at 11 investigative sites.
Pre-assignment details
Of the 95 enrolled, 6 subjects were discontinued as screen failures prior to randomization, and 4 subjects were discontinued post randomization and prior to exposure to the study lenses. This reporting group includes all subjects exposed to any study lenses evaluated in this study.
Participants by arm
| Arm | Count |
|---|---|
| LID230451, Then ULTRA MFfA 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 were 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 were removed daily for cleaning and disinfection with CLEAR CARE. | 46 |
| ULTRA MFfA, Then LID230451 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 were 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 were removed daily for cleaning and disinfection with CLEAR CARE. | 39 |
| Total | 85 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Wear Period (Approx 30 Days) | Screen failure | 1 | 0 |
| First Wear Period (Approx 30 Days) | Withdrawal by Subject | 0 | 1 |
| Washout Period (Approx 2-4 Days) | Adverse Event | 0 | 1 |
Baseline characteristics
| Characteristic | LID230451, Then ULTRA MFfA | ULTRA MFfA, Then LID230451 | Total |
|---|---|---|---|
| Age, Continuous | 55.8 years STANDARD_DEVIATION 9.4 | 55.9 years STANDARD_DEVIATION 9.4 | 55.9 years STANDARD_DEVIATION 9.4 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 5 Participants | 10 Participants | 15 Participants |
| Race/Ethnicity, Customized Black or African American | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 39 Participants | 27 Participants | 66 Participants |
| Region of Enrollment United States | 46 participants | 39 participants | 85 participants |
| Sex: Female, Male Female | 29 Participants | 27 Participants | 56 Participants |
| Sex: Female, Male Male | 17 Participants | 12 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 85 | 0 / 0 | 0 / 83 | 0 / 0 | 0 / 84 |
| other Total, other adverse events | 0 / 85 | 0 / 166 | 0 / 83 | 0 / 168 | 0 / 84 |
| serious Total, serious adverse events | 0 / 85 | 0 / 166 | 0 / 83 | 0 / 168 | 0 / 84 |
Outcome results
Primary
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.
Population: Full Analysis Set with data at visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LID230451 | Mean Binocular Visual Acuity at Distance (4 Meters) at Day 30 With Study Lenses | -0.50 logMAR | Standard Deviation 0.1 |
| ULTRA MFfA | Mean Binocular Visual Acuity at Distance (4 Meters) at Day 30 With Study Lenses | -0.08 logMAR | Standard Deviation 0.09 |