Presbyopia
Conditions
Keywords
Multifocal, Myopia, Hyperopia
Brief summary
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.
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 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.
Interventions
DEVICESerafilcon A multifocal contact lenses
Investigational multifocal soft contact lenses
DEVICESenofilcon A multifocal contact lenses
Commercially available multifocal soft contact lenses
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: * Current wearer of biweekly/monthly replacement multifocal soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 6 months. * Manifest cylinder equal to or less than 0.75 diopter (D) in each eye. * Able to wear contact lenses within the available power range with a near ADD of +0.75 D to +2.50 D in each eye. * Other protocol-defined inclusion criteria may apply. Key
Exclusion criteria
* Currently pregnant or lactating. * History of amblyopia, strabismus, or binocular vision abnormalities. * Habitual Oasys MF contact lens wearers or daily disposable contact lens wearers. * 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 Week 1 | Week 1 (Day 7 -0/+1 days) of each wear period. A wear period was 14 days (-0/+2 days) 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). No hypothesis testing was pre-specified for this endpoint. |
Countries
United States
Participant flow
Recruitment details
Subjects were enrolled at 8 investigative sites.
Pre-assignment details
Of the 106 subjects enrolled, 2 subjects were discontinued prior to exposure to the study product. This reporting group population includes all subjects exposed to any study lenses evaluated in this study.
Participants by arm
| Arm | Count |
|---|---|
| LID233309, Then Oasys MF 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 were worn in a daily wear mode in both eyes (bilaterally) during waking hours for at least 10 hours per day. Each wear period was 14 days (-0/+2). CLEAR CARE was used for daily cleaning and disinfection. | 53 |
| Oasys MF, Then LID233309 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 were worn in a daily wear mode in both eyes (bilaterally) during waking hours for at least 10 hours per day. Each wear period was 14 days (-0/+2). CLEAR CARE was used for daily cleaning and disinfection. | 51 |
| Total | 104 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Wear Period (Approx 14 Days) | As Per Sponsor Guidance | 1 | 1 |
| First Wear Period (Approx 14 Days) | Protocol Violation | 4 | 3 |
Baseline characteristics
| Characteristic | LID233309, Then Oasys MF | Oasys MF, Then LID233309 | Total |
|---|---|---|---|
| Age, Continuous | 52.1 years STANDARD_DEVIATION 7 | 53.5 years STANDARD_DEVIATION 6.7 | 52.8 years STANDARD_DEVIATION 6.9 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Asian | 14 participants | 11 participants | 25 participants |
| Race/Ethnicity, Customized Black or African American | 2 participants | 1 participants | 3 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 3 participants | 2 participants | 5 participants |
| Race/Ethnicity, Customized Multi-Racial | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 50 participants | 49 participants | 99 participants |
| Race/Ethnicity, Customized Other | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized White | 37 participants | 37 participants | 74 participants |
| Region of Enrollment United States | 53 participants | 51 participants | 104 participants |
| Sex: Female, Male Female | 35 Participants | 37 Participants | 72 Participants |
| Sex: Female, Male Male | 18 Participants | 14 Participants | 32 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 / 104 | 0 / 0 | 0 / 100 | 0 / 0 | 0 / 99 |
| other Total, other adverse events | 0 / 104 | 0 / 200 | 0 / 100 | 0 / 198 | 0 / 99 |
| serious Total, serious adverse events | 0 / 104 | 0 / 200 | 0 / 100 | 0 / 198 | 0 / 99 |
Outcome results
Primary
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.
Population: Full Analysis Set with data at visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LID233309 | Mean Binocular Visual Acuity at Distance (4 Meters) at Week 1 | -0.08 logMAR | Standard Deviation 0.09 |
| Oasys MF | Mean Binocular Visual Acuity at Distance (4 Meters) at Week 1 | -0.08 logMAR | Standard Deviation 0.09 |