Presbyopia
Conditions
Brief summary
The purpose of this trial is to evaluate the use of multifocal contact lenses in people who use reading glasses only.
Interventions
Commercially marketed, silicone hydrogel, multifocal, soft contact lenses FDA-approved for up to 4 weeks recommended replacement schedule and up to 6 nights of extended (overnight) wear.
Sponsors
CIBA VISION
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 48 Years
Healthy volunteers
No
Inclusion criteria
* Is between 40 and 48 years of age (inclusive). * Has read and signed the Informed Consent. * Is willing and able to follow instructions and maintain the appointment schedule. * Wears reading spectacles for close work. * Other protocol-defined inclusion/
Exclusion criteria
may apply.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Convenience With Contact Lenses | 3 weeks of wear | Overall convenience with contact lenses, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of 3 weeks of wear time. Overall convenience is measured on a 4-point scale: 1=very satisfied; 2=satisfied; 3=dissatisfied; 4=very dissatisfied. Results were reported as a percentage of participants who responded, very satisfied or satisfied. |
Participant flow
Recruitment details
A total of 103 participants were recruited at 25 US sites from December 8, 2010, to January 31, 2011.
Pre-assignment details
Seven participants were enrolled in the study but not dispensed due to failing inclusion/exclusion criteria (1); withdrawing consent/disinterest (4); discomfort (1); and unacceptable subjective vision (1). These participants are included in the Actual Enrollment calculation, but not Participant Flow or Baseline Characteristics calculations.
Participants by arm
| Arm | Count |
|---|---|
| Lotrafilcon B Multifocal Lotrafilcon B multifocal contact lenses worn bilaterally for 3 weeks on a daily wear basis | 96 |
| Total | 96 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Handling Difficulties | 2 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Unacceptable Subjective Vision | 3 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Lotrafilcon B Multifocal |
|---|---|
| Age Continuous | 44.9 years STANDARD_DEVIATION 2.7 |
| Region of Enrollment United States | 96 participants |
| Sex: Female, Male Female | 72 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 101 |
| serious Total, serious adverse events | 0 / 101 |
Outcome results
Primary
Overall Convenience With Contact Lenses
Overall convenience with contact lenses, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of 3 weeks of wear time. Overall convenience is measured on a 4-point scale: 1=very satisfied; 2=satisfied; 3=dissatisfied; 4=very dissatisfied. Results were reported as a percentage of participants who responded, very satisfied or satisfied.
Time frame: 3 weeks of wear
Population: Per Protocol. Two participants were excluded from analysis due to major protocol deviations as determined by masked review.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lotrafilcon B Multifocal | Overall Convenience With Contact Lenses | 82.4 Percentage of participants |