Refractive Errors, Presbyopia, Astigmatism
Conditions
Keywords
Contact Lenses
Brief summary
The purpose of this clinical trial is to assess on-eye performance and overall fit of an investigational multifocal toric contact lens to aid in confirmation of the study lens design.
Detailed description
Subjects will attend 3 study visits with a planned individual duration of participation of up to 10 days.
Interventions
DEVICELehfilcon A multifocal toric contact lenses
Investigational silicone hydrogel contact lenses
DEVICESamfilcon A multifocal toric contact lenses
Commercially available silicone hydrogel contact lenses
DEVICECLEAR CARE
Hydrogen peroxide based contact lens cleaning and disinfecting solution
Sponsors
Alcon Research
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Subjects will wear the products (test and comparator) in a predetermined order.
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Requires ADD (additional power for near vision); * Currently wears multifocal soft contact lenses in both eyes during the past 3 months; * Manifest cylinder power between -0.75 diopter (D) and -1.00 D; * Best Corrected Visual Acuity (BCVA) of logMAR 0.10 (Snellen 20/25) or better in each eye. * Other protocol-specified inclusion criteria may apply. Key
Exclusion criteria
* Any anterior segment 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; * Current or history of pathologically dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear; * Monovision contact lens wear. * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Distance Visual Acuity (VA) With Study Lenses | Day 2, each wear period. A wear period was approximately 2 days. | Visual Acuity (VA) was assessed binocularly (both eyes together) with study lenses in place at a distance of 4 meters using letter charts. VA was recorded in logarithm minimum angle of resolution (logMAR), where 0.0 logMAR equates to 20/20 Snellen (normal distance eyesight). A lower number indicates better visual acuity. No hypothesis testing is pre-specified for this endpoint. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from 1 investigative site located in the United States.
Pre-assignment details
Of the 18 enrolled, 9 were exited prior to study lens assignment as screen failures. This reporting group includes all participants exposed to any study lenses evaluated in this study (9).
Participants by arm
| Arm | Count |
|---|---|
| LID223188, Then Ultra MFT Lehfilcon A multifocal toric contact lenses worn first, with samfilcon A multifocal toric contact lenses worn second. Each product was worn bilaterally (in both eyes) during waking hours for approximately 2 days. CLEAR CARE was used for daily contact lens cleaning and disinfection. | 5 |
| Ultra MFT, Then LID223188 Samfilcon A multifocal toric contact lenses worn first, with lehfilcon A multifocal toric contact lenses worn second. Each product was worn bilaterally (in both eyes) during waking hours for approximately 2 days. CLEAR CARE was used for daily contact lens cleaning and disinfection. | 4 |
| Total | 9 |
Baseline characteristics
| Characteristic | LID223188, Then Ultra MFT | Ultra MFT, Then LID223188 | Total |
|---|---|---|---|
| Age, Continuous | 58.6 years STANDARD_DEVIATION 10 | 65.0 years STANDARD_DEVIATION 3.2 | 61.4 years STANDARD_DEVIATION 8 |
| 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 | 3 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 1 Participants | 0 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 | 4 Participants | 4 Participants | 8 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 1 Participants | 4 Participants | 5 Participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 6 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 / 9 | 0 / 18 | 0 / 9 | 0 / 18 | 0 / 9 |
| other Total, other adverse events | 0 / 9 | 0 / 18 | 0 / 9 | 0 / 18 | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 | 0 / 18 | 0 / 9 | 0 / 18 | 0 / 9 |
Outcome results
Primary
Mean Distance Visual Acuity (VA) With Study Lenses
Visual Acuity (VA) was assessed binocularly (both eyes together) with study lenses in place at a distance of 4 meters using letter charts. VA was recorded in logarithm minimum angle of resolution (logMAR), where 0.0 logMAR equates to 20/20 Snellen (normal distance eyesight). A lower number indicates better visual acuity. No hypothesis testing is pre-specified for this endpoint.
Time frame: Day 2, each wear period. A wear period was approximately 2 days.
Population: This analysis population includes all subjects/eyes exposed to any study lenses evaluated in this study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LID223188 | Mean Distance Visual Acuity (VA) With Study Lenses | -0.04 logMAR | Standard Deviation 0.09 |
| Ultra MFT | Mean Distance Visual Acuity (VA) With Study Lenses | -0.09 logMAR | Standard Deviation 0.07 |