Presbyopia
Conditions
Keywords
Contact lenses, Multifocal
Brief summary
The primary objective of this study is to demonstrate noninferiority in visual acuity at distance when wearing the test contact lenses (LID210464) compared to the control contact lenses (AOHG MF) after 30 days of wear.
Detailed description
Subjects will be expected to attend 4 office visits and will be dispensed study contact lenses (test lenses and control lenses) for a 30-day duration of bilateral wear for each study lens type (total of approximately 60 days of contact lens wear).
Interventions
Investigational frequent replacement soft contact lens indicated for the optical correction of presbyopia
Commercially available frequent replacement soft contact lens indicated for the optical correction of presbyopia
DEVICECLEAR CARE®
Hydrogen peroxide-based contact lens cleaning and disinfecting solution
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: * Able to understand and sign an informed consent form that has been approved by an Institutional Review Board. * Willing and able to attend all study visits as required by the protocol. * Willing to stop wearing habitual contact lenses for the duration of the study. * Currently wearing daily disposable and biweekly/monthly replacement multifocal soft contact lenses in both eyes at least 5 days per week and at least 8 hours per day for at least 3 months. AOHG MF wearers may be included. * Other protocol-specified inclusion criteria may apply. Key
Exclusion criteria
* Any eye infection, inflammation, abnormality, or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator. * Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator. * History of refractive surgery or planning to have refractive surgery during the study. * Current or history of pathologically dry eye. * Currently pregnant or lactating. * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Least Squares Mean Binocular High Contrast/High Illumination Visual Acuity at Distance With Study Lenses | Day 30, each wear period. A wear period was approximately 30 days. | Visual acuity (VA) was assessed with study lenses in place under high contrast, high illumination. VA was collected for both eyes together using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from 8 investigative sites located in the United States.
Pre-assignment details
This reporting group includes all enrolled participants, as treated (101). Note, one subject that was randomized to AOHG MF, then LID210464 was exposed to LID210464, then AOHG MF instead.
Participants by arm
| Arm | Count |
|---|---|
| LID210464, Then AOHG MF Lehfilcon A multifocal contact lenses (LID210464) worn in Period 1, with lotrafilcon B multifocal contact lenses (AOHG MF) worn in Period 2, as randomized. Each study lens type was worn bilaterally (in both eyes) for 30 days. CLEAR CARE® was used for daily contact lens cleaning and disinfecting. | 51 |
| AOHG MF, Then LID210464 Lotrafilcon B multifocal contact lenses (AOHG MF) worn in Period 1, with lehfilcon A multifocal contact lenses (LID210464) worn in Period 2, as randomized. Each study lens type was worn bilaterally (in both eyes) for 30 days. CLEAR CARE® was used for nightly contact lens cleaning and disinfecting. | 50 |
| Total | 101 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1, Approximately 30 Days | Adverse Event | 1 | 0 |
Baseline characteristics
| Characteristic | LID210464, Then AOHG MF | Total | AOHG MF, Then LID210464 |
|---|---|---|---|
| Age, Continuous | 51.5 years STANDARD_DEVIATION 6.9 | 50.8 years STANDARD_DEVIATION 6.5 | 50.0 years STANDARD_DEVIATION 6.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 3 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 50 Participants | 98 Participants | 48 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 50 Participants | 98 Participants | 48 Participants |
| Region of Enrollment United States | 51 participants | 101 participants | 50 participants |
| Sex: Female, Male Female | 42 Participants | 80 Participants | 38 Participants |
| Sex: Female, Male Male | 9 Participants | 21 Participants | 12 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 / 101 | 0 / 202 | 0 / 101 | 0 / 200 | 0 / 100 |
| other Total, other adverse events | 0 / 101 | 0 / 202 | 0 / 101 | 0 / 200 | 0 / 100 |
| serious Total, serious adverse events | 0 / 101 | 0 / 202 | 0 / 101 | 0 / 200 | 1 / 100 |
Outcome results
Primary
Least Squares Mean Binocular High Contrast/High Illumination Visual Acuity at Distance With Study Lenses
Visual acuity (VA) was assessed with study lenses in place under high contrast, high illumination. VA was collected for both eyes together using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity.
Time frame: Day 30, each wear period. A wear period was approximately 30 days.
Population: Full Analysis Set: All randomized subjects/eyes exposed to any study lenses evaluated in this study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| LID210464 | Least Squares Mean Binocular High Contrast/High Illumination Visual Acuity at Distance With Study Lenses | -0.10 logMAR | Standard Error 0.01 |
| AOHG MF | Least Squares Mean Binocular High Contrast/High Illumination Visual Acuity at Distance With Study Lenses | -0.09 logMAR | Standard Error 0.01 |