Myopia, Presbyopia
Conditions
Brief summary
The purpose of this trial is to evaluate and compare the clinical performance of two multifocal contact lenses.
Interventions
DEVICENelfilcon A multifocal contact lens, investigational
Investigational, soft, multifocal contact lens for daily wear, daily disposable use.
DEVICENelfilcon A multifocal contact lens, commercial
Commercially marketed, soft, multifocal contact lens FDA-approved for daily wear, daily disposable use.
Sponsors
CIBA VISION
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
41 Years to 68 Years
Healthy volunteers
No
Inclusion criteria
* Age 41 to 68 (inclusive). * Spectacle add between +0.75 and +2.75D (inclusive). * Habitual spectacle prescription ≤ 1.00DC (cyl). * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Eye injury or surgery within twelve weeks of enrollment. * Pre-existing ocular irritation that would preclude contact lens fitting. * Currently enrolled in a clinical trial. * Prior refractive surgery. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| End of Day Comfort | 5 days of wear, lenses replaced daily | End of day comfort was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. End of day comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent. |
| End of Day Dryness | 5 days of wear, lenses replaced daily | End of day dryness was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. End of day dryness was measured on a 10-point scale, with 1 being very dry and 10 being not dry. |
| Handling at Removal | 5 days of wear, lenses replaced daily | Handling at removal was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. Handling at removal was measured on a 10-point scale, with 1 being poor/difficult and 10 being excellent/easy. |
| Overall Vision | 5 days of wear, lenses replaced daily | Overall vision was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. Overall vision was measured on a 10-point scale, with 1 being poor and 10 being excellent. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Fit | Day 5, lenses replaced daily | Overall lens fit was assessed by the investigator at study visit using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was assessed by eye and graded on a 5-point scale, with 2=unacceptably loose, 1= acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight |
Participant flow
Recruitment details
A total of 79 participants were recruited at 7 US sites from December 3, 2010, to January 20, 2011.
Pre-assignment details
Seven participants were enrolled in the study but not dispensed due to failed inclusion/exclusion criteria (2); unsatisfactory vision (2); unacceptable comfort (1); and subject withdrawal (2). These participants are included in the Actual Enrollment calculation, but not Participant Flow or Baseline Characteristics calculations.
Participants by arm
| Arm | Count |
|---|---|
| Overall This reporting group includes all enrolled and dispensed participants. | 72 |
| Total | 72 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age Continuous | 50.1 years STANDARD_DEVIATION 5.7 |
| Sex: Female, Male Female | 53 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 77 | 0 / 77 |
| serious Total, serious adverse events | 0 / 77 | 0 / 77 |
Outcome results
Primary
End of Day Comfort
End of day comfort was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. End of day comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Time frame: 5 days of wear, lenses replaced daily
Population: Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nelfilcon A Investigational | End of Day Comfort | 7.7 Units on a scale | Standard Deviation 2.2 |
| Nelfilcon A Commercial | End of Day Comfort | 7.2 Units on a scale | Standard Deviation 2.3 |
Primary
End of Day Dryness
End of day dryness was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. End of day dryness was measured on a 10-point scale, with 1 being very dry and 10 being not dry.
Time frame: 5 days of wear, lenses replaced daily
Population: Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nelfilcon A Investigational | End of Day Dryness | 7.2 Units on a Scale | Standard Deviation 2.5 |
| Nelfilcon A Commercial | End of Day Dryness | 6.9 Units on a Scale | Standard Deviation 2.5 |
Primary
Handling at Removal
Handling at removal was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. Handling at removal was measured on a 10-point scale, with 1 being poor/difficult and 10 being excellent/easy.
Time frame: 5 days of wear, lenses replaced daily
Population: Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nelfilcon A Investigational | Handling at Removal | 8.7 Units on a Scale | Standard Deviation 1.6 |
| Nelfilcon A Commercial | Handling at Removal | 8.2 Units on a Scale | Standard Deviation 2.1 |
Primary
Overall Vision
Overall vision was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. Overall vision was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Time frame: 5 days of wear, lenses replaced daily
Population: Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nelfilcon A Investigational | Overall Vision | 7.2 Units on a Scale | Standard Deviation 1.9 |
| Nelfilcon A Commercial | Overall Vision | 6.2 Units on a Scale | Standard Deviation 2.1 |
Secondary
Overall Fit
Overall lens fit was assessed by the investigator at study visit using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was assessed by eye and graded on a 5-point scale, with 2=unacceptably loose, 1= acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight
Time frame: Day 5, lenses replaced daily
Population: Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nelfilcon A Investigational | Overall Fit | 0.0 Units on a Scale | Standard Deviation 0.5 |
| Nelfilcon A Commercial | Overall Fit | -0.1 Units on a Scale | Standard Deviation 0.6 |