Myopia
Conditions
Keywords
myopia, contact lenses, dry eyes, comfort, replacement
Brief summary
The purpose of this study was to evaluate the performance of a novel silicone hydrogel contact lens, DAILIES TOTAL1® (DT1) compared to the standard hydrogel material in 1-DAY ACUVUE® MOIST® (1DAVM) contact lens in contact lens wearers identified as having contact lens-related dryness symptoms.
Detailed description
Three study visits occurred over the course of 28 ± 3 days.
Interventions
Silicone hydrogel contact lenses for daily wear, daily disposable use
Hydrogel contact lenses for daily wear, daily disposable use
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 43 Years
Healthy volunteers
No
Inclusion criteria
* Be of legal age of consent and sign written Informed Consent Document and HIPAA form. * Currently wearing soft contact lenses and identified as having contact lens-related dryness symptoms based upon responses to the Contact Lens Dry Eye Questionnaire. * Wearing either daily disposable contact lenses or bi-weekly/monthly replacement contact lenses, daily wear use only (no extended wear use). * Able to achieve distance visual acuity of at least 20/25 in each eye with study lenses in the available parameters, -0.50D to -6.00D. * Willing to wear study lenses for at least 8 hours/day and at least 5 days/week. * Willing and able to follow instructions and maintain the appointment schedule. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Neophyte or current wearer of DAILIES TOTAL1® or 1-DAY ACUVUE® MOIST™ contact lenses. * Requires monovision or presbyopic correction. * Any systemic or ocular disease or disorder complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study. * Recent (within 7 days of enrollment) or current ocular infection, active ocular inflammation, glaucoma or preauricular lymphadenopathy. * Clinically significant lash or lid abnormality. * Systemic disease that, in the investigator's best judgment, would prohibit or confound safe contact lens wear. * History of ocular surgery/trauma within the last 6 months. * Topical or systemic antibiotics use within 7 days of enrollment. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Subjective Contact Lens-related Dryness Symptoms at Week 4 as Assessed by the CLDEQ | Day 0, Week 4 | Contact lens symptoms were evaluated using the Contact Lens and Dry Eye Questionnaire (CLDEQ). The participant indicated the frequency with which 9 common contact lens-related ocular surface dryness symptoms were experienced over the previous week. Each symptom was rated on a 5-point scale (1=never, 5=constantly). Both eyes contributed to the mean. A more negative change number indicates a greater perceived improvement, namely, lessening of the symptom. |
Participant flow
Recruitment details
Participants were recruited from 1 US study center.
Pre-assignment details
This reporting group includes all enrolled and randomized participants.
Participants by arm
| Arm | Count |
|---|---|
| DAILIES TOTAL1 Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks | 30 |
| 1DAVM Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Corneal Staining | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | DAILIES TOTAL1 | 1DAVM | Total |
|---|---|---|---|
| Age, Continuous | 23.26 years STANDARD_DEVIATION 4.28 | 24.53 years STANDARD_DEVIATION 4.83 | 23.89 years STANDARD_DEVIATION 4.56 |
| Sex: Female, Male Female | 23 Participants | 24 Participants | 47 Participants |
| Sex: Female, Male Male | 7 Participants | 6 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 30 | 8 / 32 |
| serious Total, serious adverse events | 0 / 30 | 0 / 32 |
Outcome results
Primary
Mean Change From Baseline in Subjective Contact Lens-related Dryness Symptoms at Week 4 as Assessed by the CLDEQ
Contact lens symptoms were evaluated using the Contact Lens and Dry Eye Questionnaire (CLDEQ). The participant indicated the frequency with which 9 common contact lens-related ocular surface dryness symptoms were experienced over the previous week. Each symptom was rated on a 5-point scale (1=never, 5=constantly). Both eyes contributed to the mean. A more negative change number indicates a greater perceived improvement, namely, lessening of the symptom.
Time frame: Day 0, Week 4
Population: All enrolled and randomized participants who completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DAILIES TOTAL1 | Mean Change From Baseline in Subjective Contact Lens-related Dryness Symptoms at Week 4 as Assessed by the CLDEQ | Eyes feel dry | -1.07 Units on a scale | Standard Deviation 0.68 |
| DAILIES TOTAL1 | Mean Change From Baseline in Subjective Contact Lens-related Dryness Symptoms at Week 4 as Assessed by the CLDEQ | Feel something in the eye | -0.47 Units on a scale | Standard Deviation 0.58 |
| DAILIES TOTAL1 | Mean Change From Baseline in Subjective Contact Lens-related Dryness Symptoms at Week 4 as Assessed by the CLDEQ | Eyes feel irritated | -0.42 Units on a scale | Standard Deviation 0.32 |
| DAILIES TOTAL1 | Mean Change From Baseline in Subjective Contact Lens-related Dryness Symptoms at Week 4 as Assessed by the CLDEQ | Eyes burning and stinging | -0.25 Units on a scale | Standard Deviation 0.34 |
| DAILIES TOTAL1 | Mean Change From Baseline in Subjective Contact Lens-related Dryness Symptoms at Week 4 as Assessed by the CLDEQ | Vision change between clear and blurry | -0.04 Units on a scale | Standard Deviation 0.04 |
| DAILIES TOTAL1 | Mean Change From Baseline in Subjective Contact Lens-related Dryness Symptoms at Week 4 as Assessed by the CLDEQ | Eyes feel unusually sensitive to bright light | -0.23 Units on a scale | Standard Deviation 0.35 |
| DAILIES TOTAL1 | Mean Change From Baseline in Subjective Contact Lens-related Dryness Symptoms at Week 4 as Assessed by the CLDEQ | Eyes feel gritty and scratchy | -0.10 Units on a scale | Standard Deviation 0.1 |
| DAILIES TOTAL1 | Mean Change From Baseline in Subjective Contact Lens-related Dryness Symptoms at Week 4 as Assessed by the CLDEQ | Eyes itch | -0.43 Units on a scale | Standard Deviation 0.41 |
| DAILIES TOTAL1 | Mean Change From Baseline in Subjective Contact Lens-related Dryness Symptoms at Week 4 as Assessed by the CLDEQ | Eyes feel uncomfortable | -0.21 Units on a scale | Standard Deviation 0.13 |
| 1DAVM | Mean Change From Baseline in Subjective Contact Lens-related Dryness Symptoms at Week 4 as Assessed by the CLDEQ | Eyes itch | -0.38 Units on a scale | Standard Deviation 0.46 |
| 1DAVM | Mean Change From Baseline in Subjective Contact Lens-related Dryness Symptoms at Week 4 as Assessed by the CLDEQ | Eyes feel uncomfortable | -0.17 Units on a scale | Standard Deviation 0.16 |
| 1DAVM | Mean Change From Baseline in Subjective Contact Lens-related Dryness Symptoms at Week 4 as Assessed by the CLDEQ | Eyes feel dry | -0.92 Units on a scale | Standard Deviation 0.9 |
| 1DAVM | Mean Change From Baseline in Subjective Contact Lens-related Dryness Symptoms at Week 4 as Assessed by the CLDEQ | Vision change between clear and blurry | -0.04 Units on a scale | Standard Deviation 0.04 |
| 1DAVM | Mean Change From Baseline in Subjective Contact Lens-related Dryness Symptoms at Week 4 as Assessed by the CLDEQ | Eyes feel irritated | -0.31 Units on a scale | Standard Deviation 0.28 |
| 1DAVM | Mean Change From Baseline in Subjective Contact Lens-related Dryness Symptoms at Week 4 as Assessed by the CLDEQ | Eyes feel gritty and scratchy | -0.07 Units on a scale | Standard Deviation 0.07 |
| 1DAVM | Mean Change From Baseline in Subjective Contact Lens-related Dryness Symptoms at Week 4 as Assessed by the CLDEQ | Feel something in the eye | -0.38 Units on a scale | Standard Deviation 0.54 |
| 1DAVM | Mean Change From Baseline in Subjective Contact Lens-related Dryness Symptoms at Week 4 as Assessed by the CLDEQ | Eyes burning and stinging | -0.28 Units on a scale | Standard Deviation 0.36 |
| 1DAVM | Mean Change From Baseline in Subjective Contact Lens-related Dryness Symptoms at Week 4 as Assessed by the CLDEQ | Eyes feel unusually sensitive to bright light | -0.19 Units on a scale | Standard Deviation 0.32 |