Myopia, Hyperopia
Conditions
Brief summary
The purpose of this study is to explore the effect of masking on subjective ratings for two daily disposable contact lenses.
Interventions
DEVICENelfilcon A contact lens
Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Blister pack label and lens packaging visible to participant. Lenses inserted and removed by participant.
DEVICENelfilcon A contact lens with comfort additive (DACP), unmasked
Commercially marketed, soft, hydrogel contact lens with comfort additive for daily wear, daily disposable use. Blister pack label and lens packaging visible to participant. Lenses and removed inserted by participant.
DEVICENelfilcon A contact lens with comfort additive (DACP), masked
Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Blister pack label and packaging not visible to participant. Lenses inserted and removed by the investigator.
DEVICENelfilcon A contact lens with comfort additive (DACP), partially masked
Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Lens name and manufacturer on blister pack label concealed from participant. Lenses inserted and removed by the participant.
DEVICEEtafilcon A contact lens
Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Blister pack label and lens packaging visible to participant. Lenses inserted and removed by participant.
DEVICEEtafilcon A contact lens with comfort additive (1DAVM), unmasked
Commercially marketed, soft, hydrogel contact lens with comfort additive for daily wear, daily disposable use. Blister pack label and lens packaging visible to participant. Lenses inserted and removed by participant.
DEVICEEtafilcon A contact lens with comfort additive (1DAVM), masked
Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Blister pack label and packaging not visible to participant. Lenses inserted and removed by the investigator.
DEVICEEtafilcon A contact lens with comfort additive (1DAVM), partially masked
Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Lens name and manufacturer on blister pack label concealed from participant. Lenses inserted and removed by the participant.
Sponsors
CIBA VISION
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 17 years of age or older. * Ocular exam within 2 years. * Currently wearing soft contact lenses on a daily wear basis. * Contact lens prescription between +6.00D and -10.00D. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Any ocular disease. * Use of systemic or ocular medications that may affect ocular health. * Unable to achieve an acceptable fit with the study lenses. * Anisometropia \>1.00D or astigmatism \>0.75D. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Subjective Comfort | Insertion, 4 hours, 8 hours each: Day 1, Day 2, and Day 3 | Participants were asked, How would you rate your comfort with your study lenses? and indicated their response by marking a continuum line ranging from 0=very poor comfort to 100=excellent comfort. Subjective comfort was collected at three time points (insertion, 4 hours, 8 hours) for 3 days, and the comfort ratings were averaged together. |
Countries
Canada
Participant flow
Recruitment details
134 participants were recruited and enrolled at 1 study center located in Canada. A 24-hour washout period of no lens wear preceded the 30-day adaptation phase.
Pre-assignment details
18 participants were enrolled but not dispensed--i.e., discontinued prior to the 30-day adaptation phase. 116 participants started the adaptation phase, and baseline characteristics are presented for this group. 2 discontinued during the adaptation phase and 15 discontinued between adaptation and Period 1 dispense. 99 were dispensed into Period 1.
Participants by arm
| Arm | Count |
|---|---|
| Overall This reporting group includes all enrolled and dispensed participants. | 116 |
| Total | 116 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Period 1, 3 Days (Masked) | Inconvenience | 1 | 0 | 2 | 0 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age Continuous | 25 years STANDARD_DEVIATION 9 |
| Sex: Female, Male Female | 79 Participants |
| Sex: Female, Male Male | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 127 | 0 / 125 | 0 / 100 | 0 / 100 |
| serious Total, serious adverse events | 0 / 127 | 0 / 125 | 0 / 100 | 0 / 100 |
Outcome results
Primary
Average Subjective Comfort
Participants were asked, How would you rate your comfort with your study lenses? and indicated their response by marking a continuum line ranging from 0=very poor comfort to 100=excellent comfort. Subjective comfort was collected at three time points (insertion, 4 hours, 8 hours) for 3 days, and the comfort ratings were averaged together.
Time frame: Insertion, 4 hours, 8 hours each: Day 1, Day 2, and Day 3
Population: Per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nelfilcon A, Pd 1 Masked (1DAVM), Pd 2 Unmasked | Average Subjective Comfort | 94.1 Units on a scale | Standard Deviation 5.9 |
| Nelfilcon A, Pd 1 Masked (DACP), Pd 2 Unmasked | Average Subjective Comfort | 92.8 Units on a scale | Standard Deviation 6.5 |
| Etafilcon A, Pd 1 Masked (1DAVM), Pd 2 Unmasked | Average Subjective Comfort | 94.1 Units on a scale | Standard Deviation 5.6 |
| Etafilcon A, Pd 1 Masked (DACP), Pd 2 Unmasked | Average Subjective Comfort | 91.8 Units on a scale | Standard Deviation 6.4 |
| Nelfilcon A, Pd 1 Masked, Pd 2 Unmasked (1DAVM) | Average Subjective Comfort | 93.7 Units on a scale | Standard Deviation 6 |
| Nelfilcon A, Pd 1 Masked, Pd 2 Unmasked (DACP) | Average Subjective Comfort | 93.3 Units on a scale | Standard Deviation 5.7 |
| Etafilcon A, Pd 1 Masked, Pd 2 Unmasked (1DAVM) | Average Subjective Comfort | 95.2 Units on a scale | Standard Deviation 5.8 |
| Etafilcon A, Pd 1 Masked, Pd 2 Unmasked (DACP) | Average Subjective Comfort | 93.7 Units on a scale | Standard Deviation 6.6 |
| Nelfilcon A, Pd 1 Masked (1DAVM), Pd 2 Partial | Average Subjective Comfort | 93.4 Units on a scale | Standard Deviation 6.9 |
| Nelfilcon A, Pd 1 Masked (DACP), Pd 2 Partial | Average Subjective Comfort | 93.4 Units on a scale | Standard Deviation 7.1 |
| Etafilcon A, Pd 1 Masked (1DAVM), Pd 2 Partial | Average Subjective Comfort | 93.6 Units on a scale | Standard Deviation 5.1 |
| Etafilcon A, Pd 1 Masked (DACP), Pd 2 Partial | Average Subjective Comfort | 92.2 Units on a scale | Standard Deviation 5.6 |
| Nelfilcon A, Pd 1 Masked, Pd 2 Partial (1DAVM) | Average Subjective Comfort | 92.3 Units on a scale | Standard Deviation 7 |
| Nelfilcon A, Pd 1 Masked, Pd 2 Partial (DACP) | Average Subjective Comfort | 93.1 Units on a scale | Standard Deviation 7 |
| Etafilcon A, Pd 1 Masked, Pd 2 Partial (1DAVM) | Average Subjective Comfort | 93.5 Units on a scale | Standard Deviation 6.7 |
| Etafilcon A, Pd 1 Masked, Pd 2 Partial (DACP) | Average Subjective Comfort | 92.6 Units on a scale | Standard Deviation 5.8 |
Comparison: Unmasked minus masked95% CI: [-2.2, 1.4]
Comparison: Unmasked minus masked95% CI: [-1.5, 2.5]
Comparison: Unmasked minus masked95% CI: [-0.1, 2.2]
Comparison: Unmasked minus masked95% CI: [0.2, 3.5]
Comparison: Partial masked minus masked95% CI: [-3.3, 1.2]
Comparison: Partial masked minus masked95% CI: [-1.9, 1.1]
Comparison: Partial masked minus masked95% CI: [-2.9, 2.7]
Comparison: Partial masked minus masked95% CI: [-1.1, 1.9]