Lid Wiper Epitheliopathy
Conditions
Keywords
Ocular discomfort, Contact lenses, Myopia
Brief summary
The purpose of this study is to evaluate the effect of contact lens lubricity on lid wiper epitheliopathy (LWE) in symptomatic contact lens wearers. LWE is defined as an alteration of that portion of the marginal conjunctival epithelium of the upper eyelid that wipes the ocular surface during blinking.
Detailed description
This study will be conducted in two stages. In Stage 1, participants will wear either spectacles or contact lenses for two weeks to determine the impact of interruption of contact lens wear on LWE. In Stage 2, a second cohort of participants will wear one of two contact lens brands for two weeks, and LWE and ocular discomfort will be compared.
Interventions
DEVICESpectacles
Per participant's habitual prescription
Silicone hydrogel single vision contact lenses
Hydrogel single vision contact lenses
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Sign Informed Consent document. * Severe lid wiper epitheliopathy (upper lid) in either eye. * Currently wearing spherical daily disposable soft contact lenses or daily wear soft contact lenses in both eyes with at least 3 months of contact lens wearing experience. * Symptomatic as determined by the SPEED questionnaire. * Willing to follow visit schedule. * Habitual contact lens power with the range of -1.00 to -6.00 diopters (D) with best corrected distance visual acuity greater than or equal to 20/25 in each eye. * Astigmatism less than or equal to 0.75D. * Possess spectacles which provide visual acuity of at least 20/25 in each eye. * Willing and able to complete daily diaries. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Eye injury within 12 weeks immediately prior to enrollment. * Any ocular condition that would contraindicate contact lens wear. * Any use of systemic or ocular medications that would contraindicate contact lens wear, as determined by the investigator. * Currently wearing toric or multifocal soft contact lenses. * Participation in a clinical study (including contact lens or contact lens care product) within the previous 30 days. * Routinely sleeps in lenses for at least 1 night per week. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stage 1: Percent of Eyes Experiencing at Least 1 Grade Reduction in LWE at 2 Weeks | Baseline, Week 2 | LWE was measured by slit lamp evaluation of fluorescein and lissamine green staining of the upper eyelid. LWE was graded on a scale from 0 to 3, where 0=none and 3=severe. The percent of eyes experiencing at least a 1 grade reduction in LWE (from baseline) at the 2-week visit was compared between groups. One eye (study eye) contributed to the analysis. |
| Stage 2: Percent of Eyes Experiencing at Least 1 Grade Reduction in LWE at 2 Weeks | Baseline, Week 2 | This outcome measure was not evaluated since primary efficacy was not demonstrated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stage 2: Change From Baseline in Ocular Discomfort Score (as Measured by SPEED) at 2 Weeks | Baseline, Week 2 | This outcome measure was not evaluated since primary efficacy was not demonstrated. |
Participant flow
Recruitment details
Participants were recruited from 23 study centers located in the US.
Pre-assignment details
Of the 187 enrolled, 135 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants. Results from Stage 1 were planned to be used to appropriately power Stage 2 of the study. Since primary efficacy cannot be demonstrated in Stage 1, Stage 2 of this study was not conducted.
Participants by arm
| Arm | Count |
|---|---|
| Spectacles, Stage 1 Spectacles per participant's habitual perscription worn for 2 weeks | 25 |
| 1-DAY ACUVUE, Stage 1 Contact lenses worn bilaterally (in both eyes) at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode | 27 |
| Total | 52 |
Baseline characteristics
| Characteristic | Spectacles, Stage 1 | 1-DAY ACUVUE, Stage 1 | Total |
|---|---|---|---|
| Age, Continuous | 34.1 years STANDARD_DEVIATION 10.9 | 34.1 years STANDARD_DEVIATION 9.4 | 34.1 years STANDARD_DEVIATION 10.1 |
| Sex: Female, Male Female | 20 Participants | 22 Participants | 42 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 27 |
| serious Total, serious adverse events | 0 / 25 | 0 / 27 |
Outcome results
Primary
Stage 1: Percent of Eyes Experiencing at Least 1 Grade Reduction in LWE at 2 Weeks
LWE was measured by slit lamp evaluation of fluorescein and lissamine green staining of the upper eyelid. LWE was graded on a scale from 0 to 3, where 0=none and 3=severe. The percent of eyes experiencing at least a 1 grade reduction in LWE (from baseline) at the 2-week visit was compared between groups. One eye (study eye) contributed to the analysis.
Time frame: Baseline, Week 2
Population: This analysis population includes all randomized subjects who did not meet the critical deviation criteria as specified in the Deviations and Evaluability Plan. Denominator for percentages is the number of subjects with data available at both time points.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Spectacles, Stage 1 | Stage 1: Percent of Eyes Experiencing at Least 1 Grade Reduction in LWE at 2 Weeks | 100 percentage of subjects |
| 1-DAY ACUVUE, Stage 1 | Stage 1: Percent of Eyes Experiencing at Least 1 Grade Reduction in LWE at 2 Weeks | 81 percentage of subjects |
Primary
Stage 2: Percent of Eyes Experiencing at Least 1 Grade Reduction in LWE at 2 Weeks
This outcome measure was not evaluated since primary efficacy was not demonstrated.
Time frame: Baseline, Week 2
Secondary
Stage 2: Change From Baseline in Ocular Discomfort Score (as Measured by SPEED) at 2 Weeks
This outcome measure was not evaluated since primary efficacy was not demonstrated.
Time frame: Baseline, Week 2