Presbyopia, Refractive Errors
Conditions
Keywords
contact lenses, presbyopia, multifocal
Brief summary
The purpose of this study is to compare an alternative fitting guide to a current fitting guide for optimizing contact lens parameters and determining contact lens prescription.
Interventions
Contact lenses for near, intermediate, and distance correction worn on a daily wear basis and cared for with participant's habitual lens care solution
Contact lenses for near, intermediate, and distance correction worn on a daily disposable basis (removed every night and discarded) with a new pair of study lenses every morning
Contact lenses for near, intermediate, and distance correction worn on a daily disposable basis (removed every night and discarded) with a new pair of study lenses every morning
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
Subjects are unmasked to the study lenses that are dispensed, but will be masked to the fitting guides used to fit each eye.
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Sign informed consent; * Normal eyes; * Current full-time soft contact lens wearer needing presbyopia correction; * Willing to wear lenses for a minimum of five days per week, six hours per day, and attend all study visits; * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the Investigator; * Eye conditions (past or present) as specified in the protocol; * Currently wearing Alcon multifocal (MF) contact lenses; * Only one eye with functional vision; * Contact lens wear in one eye only; * Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and not willing to discontinue during the study; * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Number of Trial Lenses Needed to Fit Each Eye | VIsit 1/Day 1 | The Investigator used a multi-focal contact lens fitting guide to determine which study lens to fit |
Countries
Canada, United Kingdom, United States
Participant flow
Recruitment details
Subjects were recruited from 20 investigational sites located in the United States (14), United Kingdom (3), and Canada (3).
Pre-assignment details
Of the 188 enrolled subjects, 6 were exited prior to trial fit. This reporting group includes all subjects randomized and trial fit, as randomized (182). Safety Analysis Set is reported as exposed.
Participants by arm
| Arm | Count |
|---|---|
| AOA MF Lotrafilcon B multifocal contact lenses worn bilaterally for 10 ± 3 days | 63 |
| DACP MF Nelfilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days | 55 |
| DT1 MF Delefilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days | 59 |
| Total | 177 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Discontinued prior to exposure | 0 | 1 | 1 | 1 | 2 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | AOA MF | DACP MF | DT1 MF | Total |
|---|---|---|---|---|
| Age, Continuous | 50.6 years STANDARD_DEVIATION 6.9 | 50.1 years STANDARD_DEVIATION 6.7 | 50.1 years STANDARD_DEVIATION 6.7 | 50.3 years STANDARD_DEVIATION 6.7 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 5 Participants | 2 Participants | 6 Participants | 13 Participants |
| Race/Ethnicity, Customized Black or African American | 2 Participants | 4 Participants | 0 Participants | 6 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 1 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized White | 55 Participants | 48 Participants | 51 Participants | 154 Participants |
| Sex: Female, Male Female | 51 Participants | 46 Participants | 52 Participants | 149 Participants |
| Sex: Female, Male Male | 12 Participants | 9 Participants | 7 Participants | 28 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 | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 126 | 0 / 63 | 0 / 110 | 0 / 55 | 0 / 118 | 0 / 59 |
| other Total, other adverse events | 0 / 126 | 0 / 63 | 0 / 110 | 0 / 55 | 0 / 118 | 0 / 59 |
| serious Total, serious adverse events | 0 / 126 | 0 / 63 | 0 / 110 | 0 / 55 | 0 / 118 | 0 / 59 |
Outcome results
Primary
Mean Number of Trial Lenses Needed to Fit Each Eye
The Investigator used a multi-focal contact lens fitting guide to determine which study lens to fit
Time frame: VIsit 1/Day 1
Population: This analysis population includes all subjects randomized or assigned to study lenses as applicable, and exposed to study lenses including trial fit at Visit 1 (Full Analysis Set).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alternative | Mean Number of Trial Lenses Needed to Fit Each Eye | 1.2 lenses | Standard Deviation 0.5 |
| Current | Mean Number of Trial Lenses Needed to Fit Each Eye | 1.4 lenses | Standard Deviation 0.5 |