Astigmatism, Myopia
Conditions
Brief summary
The purpose of this trial is to compare the performance of two contact lenses for contact lens wearers with astigmatism.
Interventions
DEVICENelfilcon A investigational contact lens
Investigational, soft contact lens for astigmatism worn on a daily disposable basis.
DEVICENelfilcon A commercial contact lens
Commercially marketed, soft contact lens for astigmatism worn on a daily disposable basis.
Sponsors
CIBA VISION
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Currently wearing soft contact lenses with astigmatism correction * Other protocol inclusion criteria may apply
Exclusion criteria
* Eye injury or surgery within twelve weeks prior to enrollment * Currently enrolled in an ophthalmic clinical trial * Strabismus * Any use of medications for which contact lens wear could be contraindicated as determined by the investigator * Other protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Vision (Crisp and Clear) | 1 week of wear | Quality of vision (crisp and clear), as interpreted and reported by the participant by eye on a questionnaire as a single, retrospective evaluation of one week's wear time. Quality of vision was assessed on a 10-point scale, with 1 being poor and 10 being excellent. |
Participant flow
Pre-assignment details
This reporting group includes all enrolled and dispensed participants. One participant was enrolled but not dispensed due to unacceptable fit. This participant is 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 subjects. | 94 |
| Total | 94 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age Continuous | 35.8 years STANDARD_DEVIATION 12.2 |
| Sex: Female, Male Female | 56 Participants |
| Sex: Female, Male Male | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 95 | 0 / 93 |
| serious Total, serious adverse events | 0 / 95 | 0 / 93 |
Outcome results
Primary
Quality of Vision (Crisp and Clear)
Quality of vision (crisp and clear), as interpreted and reported by the participant by eye on a questionnaire as a single, retrospective evaluation of one week's wear time. Quality of vision was assessed on a 10-point scale, with 1 being poor and 10 being excellent.
Time frame: 1 week of wear
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 | Quality of Vision (Crisp and Clear) | 8.8 units on a scale | Standard Deviation 1.3 |
| Nelfilcon A Commercial | Quality of Vision (Crisp and Clear) | 8.6 units on a scale | Standard Deviation 1.5 |