Dry Eye Syndrome, Myopia
Conditions
Keywords
contact lens, dry eye syndrome, symptomatic, daily disposable, myopia
Brief summary
The purpose of this study was to evaluate the reduction of contact lens-related dryness symptoms when symptomatic weekly/monthly contact lens wearers were switched to DAILIES® AquaComfort Plus® lenses for a two-week period using composite scores on the Contact Lens Dry Eye Questionnaire (CLDEQ).
Interventions
Commercially marketed hydrogel contact lenses for daily wear, daily disposable use
Sponsors
Alcon Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Currently wearing weekly/monthly, silicone hydrogel or traditional hydrogel soft contact lenses at least 8 hours per day and 5 days a week during the past 6 months. * Identified as symptomatic using a baseline screening questionnaire. * Requires vision correction in both eyes with a contact lens prescription as follows: sphere powers between -0.50 and -10.00 diopter (D) and cylinder powers \</= 0.75D and no ADD correction. * Able to achieve visual acuity (VA) of at least 6/7.5 in each eye with study lenses in the available parameters. * Willing to wear study lenses for at least 8 hours/day and at least 5 days/week and discard the lenses at the end of the day and replace lenses every day with a new fresh pair. * Willing and able to follow instructions and maintain the appointment schedule. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Neophytes and current wearers of daily disposable contact lenses. * Requires monovision correction. * Any systemic or ocular disease or disorder (refractive disorder allowed) complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study. * A history of ocular surgery/trauma within the last 6 months. * Unwilling to discontinue mechanical eyelid therapy or eyelid scrubs within 14 days of enrollment and continuing during the study. * Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollment. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Contact Lens-Related Dryness Symptoms at Week 1 and Week 2 | Baseline, Week 1, Week 2 | Contact lens symptoms were evaluated using the Contact Lens Dry Eye Questionnaire (CLDEQ). Subjects rated 8 common contact lens-related ocular surface dryness symptoms at Baseline, Week 1, and Week 2 using a 5-point scale (1=never or not at all intense, 5=constantly or very intense). A scoring algorithm was used to calculate a composite score for each visit for all symptoms (-6.5 to 10). A higher composite score would indicate more contact lens related dry eye and a lower score, less contact lens related dry eye. |
Participant flow
Recruitment details
Participants were recruited from 8 study centers located in the United States.
Pre-assignment details
Of the 91 participants enrolled, 3 were exited as screen failures prior to dispensing of the study product. This reporting group includes all enrolled and dispensed participants.
Participants by arm
| Arm | Count |
|---|---|
| DAILIES® AquaComfort Plus® Nelfilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 2 weeks | 88 |
| Total | 88 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Discomfort | 1 |
| Overall Study | Protocol deviation | 1 |
| Overall Study | Unable to remove lens at the end of day | 1 |
| Overall Study | Unacceptable fit | 1 |
Baseline characteristics
| Characteristic | DAILIES® AquaComfort Plus® |
|---|---|
| Age Continuous | 32.2 years STANDARD_DEVIATION 9 |
| Region of Enrollment United States | 88 participants |
| Sex: Female, Male Female | 66 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 88 |
| serious Total, serious adverse events | 0 / 88 |
Outcome results
Primary
Mean Change From Baseline in Contact Lens-Related Dryness Symptoms at Week 1 and Week 2
Contact lens symptoms were evaluated using the Contact Lens Dry Eye Questionnaire (CLDEQ). Subjects rated 8 common contact lens-related ocular surface dryness symptoms at Baseline, Week 1, and Week 2 using a 5-point scale (1=never or not at all intense, 5=constantly or very intense). A scoring algorithm was used to calculate a composite score for each visit for all symptoms (-6.5 to 10). A higher composite score would indicate more contact lens related dry eye and a lower score, less contact lens related dry eye.
Time frame: Baseline, Week 1, Week 2
Population: Per Protocol: All enrolled and dispensed participants, minus any major protocol deviators as determined by masked review.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DAILIES® AquaComfort Plus® | Mean Change From Baseline in Contact Lens-Related Dryness Symptoms at Week 1 and Week 2 | Change from Baseline at Week 1 | -0.09 Units on a scale | Standard Deviation 1.24 |
| DAILIES® AquaComfort Plus® | Mean Change From Baseline in Contact Lens-Related Dryness Symptoms at Week 1 and Week 2 | Change from Baseline at Week 2 | -0.29 Units on a scale | Standard Deviation 1.06 |