Refractive Ametropia
Conditions
Keywords
Presbyopia
Brief summary
The purpose of this clinical trial was to evaluate the clinical performance of a manufacturing process on a frequent replacement multifocal contact lens.
Detailed description
Subjects will be expected to attend 3 scheduled visits. Eligible subjects will wear each study lens type in a cross-over fashion for approximately 2 days.
Interventions
Investigational silicone hydrogel multifocal contact lenses
Commercially available silicone hydrogel multifocal contact lenses
Commercially available cleaning and disinfection system for silicone hydrogel contact lenses
Sponsors
Alcon Research
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Able to understand and sign an consent form (ICF) that has been approved by an Institutional Review Board (IRB); * Willing to stop wearing habitual contact lenses for the duration of study participation; * Currently wearing multifocal soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months; * Other protocol-defined inclusion criteria may apply. Key
Exclusion criteria
* Any eye infection, inflammation, or 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 plan to have refractive surgery during the study; * Current or history of dry eye in either eye that would preclude contact lens wear, in the opinion of the investigator; * Monovision contact lens wear; * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Binocular Visual Acuity (VA) With Study Lenses at 4 Meters (logMAR) | Day 2, each study lens type worn during the corresponding crossover period | VA was assessed binocularly (both eyes together) using a letter chart and measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. No hypothesis testing was prespecified for this endpoint. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from 1 investigative site located in 1 country (US).
Pre-assignment details
Of the 18 enrolled, 1 participant was exited prior to study start as a screen failure. This reporting group includes all participants exposed to any study lenses evaluated in this study (17).
Participants by arm
| Arm | Count |
|---|---|
| LID#224381, Then AOHG MF Lehfilcon A multifocal contact lenses worn first, with lotrafilcon B multifocal contact lenses worn second in pre-determined order. Each study lens type was worn bilaterally (in both eyes) for approximately 2 days in a daily wear modality. CLEAR CARE was used for nightly cleaning and disinfection. | 8 |
| AOHG MF, Then LID#224381 Lotrafilcon B multifocal contact lenses worn first, with lehfilcon A multifocal contact lenses worn second in pre-determined order. Each study lens type was worn bilaterally (in both eyes) for approximately 2 days in a daily wear modality. CLEAR CARE was used for nightly cleaning and disinfection. | 9 |
| Total | 17 |
Baseline characteristics
| Characteristic | AOHG MF, Then LID#224381 | Total | LID#224381, Then AOHG MF |
|---|---|---|---|
| Age, Continuous | 62.4 years STANDARD_DEVIATION 5.2 | 63.2 years STANDARD_DEVIATION 4.7 | 64.1 years STANDARD_DEVIATION 4.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 17 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 2 Participants | 3 Participants | 1 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 | 7 Participants | 14 Participants | 7 Participants |
| Sex: Female, Male Female | 1 Participants | 4 Participants | 3 Participants |
| Sex: Female, Male Male | 8 Participants | 13 Participants | 5 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 / 17 | 0 / 34 | 0 / 17 | 0 / 34 | 0 / 17 |
| other Total, other adverse events | 0 / 17 | 0 / 34 | 0 / 17 | 0 / 34 | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 | 0 / 34 | 0 / 17 | 0 / 34 | 0 / 17 |
Outcome results
Primary
Binocular Visual Acuity (VA) With Study Lenses at 4 Meters (logMAR)
VA was assessed binocularly (both eyes together) using a letter chart and measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. No hypothesis testing was prespecified for this endpoint.
Time frame: Day 2, each study lens type worn during the corresponding crossover period
Population: This analysis population includes all subjects/eyes exposed to any study lenses evaluated in this study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LID#224381 | Binocular Visual Acuity (VA) With Study Lenses at 4 Meters (logMAR) | -0.08 logMAR | Standard Deviation 0.06 |
| AOHG MF | Binocular Visual Acuity (VA) With Study Lenses at 4 Meters (logMAR) | -0.06 logMAR | Standard Deviation 0.06 |