Myopia, Astigmatism
Conditions
Brief summary
The purpose of this trial was to compare the performance of two contact lenses commercially available for people with astigmatism.
Detailed description
This trial compared the performance of two commercialized daily disposable contact lenses in Germany.
Interventions
DEVICEnelfilcon A contact lens
Commercially marketed, nelfilcon A, toric, soft contact lens for daily disposable wear.
DEVICEetafilcon A contact lens
Commercially marketed, etafilcon A, toric, soft contact lens for daily disposable wear.
Sponsors
CIBA VISION
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Sign written informed consent. * Germany: Be of legal age. * Current monthly or weekly toric soft lens wearer able to be fit in both eyes with soft toric lenses in the study parameters. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Eye injury or surgery within twelve weeks. * Pre-existing ocular irritation that would preclude contact lens fitting. * Currently enrolled in an ophthalmic clinical trial. * Wears contact lenses overnight while sleeping. * Habitual daily disposable contact lens wearer. * Monovision correction during the study. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Vision | 1 week, replacing lenses daily | As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision was rated on a 10-point scale, with 1 being poor and 10 being excellent. |
| Overall Comfort | 1 week, replacing lenses daily | As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall comfort was rated on a 10-point scale, with 1 being poor and 10 being excellent. |
| Overall Handling | 1 week, replacing lenses daily | As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall handling was rated on a 10-point scale, with 1 being difficult and 10 being easy. |
| Overall Satisfaction | 1 week, replacing lenses daily | As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision was rated on a 10-point scale, with 1 being poor and 10 being excellent. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ease of Selecting Final Lens Power | Day 0 | As interpreted by the investigator at time of lens fitting and recorded on a questionnaire. Ease of selecting final lens power was rated on a 10-point scale, with 1 being difficult and 10 being easy. |
Participant flow
Recruitment details
Participants were recruited and enrolled from 19 German study sites.
Pre-assignment details
Two participants were enrolled, but not dispensed, due to unacceptable objective vision (1) and biomicroscopy findings (1). Baseline characteristics are presented on all enrolled and dispensed participants: 238.
Participants by arm
| Arm | Count |
|---|---|
| Overall All enrolled and dispensed participants. | 238 |
| Total | 238 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age Continuous | 31.4 years STANDARD_DEVIATION 9.7 |
| Region of Enrollment Germany | 238 participants |
| Sex: Female, Male Female | 159 Participants |
| Sex: Female, Male Male | 79 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 234 | 0 / 235 |
| serious Total, serious adverse events | 2 / 234 | 0 / 235 |
Outcome results
Primary
Overall Comfort
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall comfort was rated on a 10-point scale, with 1 being poor and 10 being excellent.
Time frame: 1 week, replacing lenses daily
Population: The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nelfilcon A | Overall Comfort | 7.8 Units on a scale | Standard Deviation 1.8 |
| Etafilcon A | Overall Comfort | 7.2 Units on a scale | Standard Deviation 2 |
Primary
Overall Handling
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall handling was rated on a 10-point scale, with 1 being difficult and 10 being easy.
Time frame: 1 week, replacing lenses daily
Population: The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nelfilcon A | Overall Handling | 8.2 Units on a scale | Standard Deviation 1.8 |
| Etafilcon A | Overall Handling | 6.8 Units on a scale | Standard Deviation 2.2 |
Primary
Overall Satisfaction
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision was rated on a 10-point scale, with 1 being poor and 10 being excellent.
Time frame: 1 week, replacing lenses daily
Population: The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nelfilcon A | Overall Satisfaction | 7.7 Units on a scale | Standard Deviation 1.9 |
| Etafilcon A | Overall Satisfaction | 6.9 Units on a scale | Standard Deviation 2 |
Primary
Overall Vision
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision was rated on a 10-point scale, with 1 being poor and 10 being excellent.
Time frame: 1 week, replacing lenses daily
Population: The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nelfilcon A | Overall Vision | 8.2 Units on a scale | Standard Deviation 1.7 |
| Etafilcon A | Overall Vision | 7.5 Units on a scale | Standard Deviation 2.1 |
Secondary
Ease of Selecting Final Lens Power
As interpreted by the investigator at time of lens fitting and recorded on a questionnaire. Ease of selecting final lens power was rated on a 10-point scale, with 1 being difficult and 10 being easy.
Time frame: Day 0
Population: The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nelfilcon A | Ease of Selecting Final Lens Power | 8.4 Units on a scale | Standard Deviation 1.5 |
| Etafilcon A | Ease of Selecting Final Lens Power | 8.8 Units on a scale | Standard Deviation 1.2 |