Refractive Error
Conditions
Brief summary
The purpose of this study is to evaluate the tear film evaporation of symptomatic soft contact lens wearers in the absence of contact lens wear and after at least 8 hours of contact lens wear.
Detailed description
This study consists of 5 visits (1 screening, 4 assessment) with a maximum of 6 days between assessment visits and at least 24 hours of no lens wear the day prior to the visit. Each subject will be randomized to a crossover sequence of 4 periods. Different study lenses will be worn during 3 of the periods, for at least 8 hours each, and the remaining period will have no lens wear.
Interventions
Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions
Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions
Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Sign an informed consent document; * Adapted, current soft contact lens wearer; * Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility) Questionnaire; * Can be successfully fitted with study lenses; * Willing to wear lenses for a minimum of 8 hours prior to each study visit; * Willing to discontinue artificial tears and rewetting drops usage on the days of study visits; * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear; * Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator; * Monocular (only 1 eye with functional vision) or fit with only one lens; * History of herpetic keratitis, ocular surgery, or irregular cornea; * Known pregnancy and lactation; * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tear Film Evaporation Rate | Day 1, Hour 8, each product | Tear film evaporation rate (amount of tears (grams or g) that evaporates over a surface area (m2) per hour (h)) assessment was performed using the VapoMeter as a non-invasive measurement of tear film evaporation over 10 seconds. Measurements were taken on both the right and left eyes after 8 hours of lens wear or no lens wear, as applicable. A higher evaporation rate can be a contributing factor to eye irritation and lens intolerance. |
Participant flow
Recruitment details
Subjects were recruited from 1 study center located in Australia.
Pre-assignment details
Of the 37 enrolled, 7 subjects were exited as screen failures prior to randomization and 1 subject discontinued after randomization prior to exposure to the investigational product. This reporting group includes all randomized and exposed subjects (29).
Participants by arm
| Arm | Count |
|---|---|
| Overall Delefilcon A, narafilcon A, and somofilcon A contact lenses worn bilaterally (in both eyes) and a period of no lens wear in a randomized crossover fashion | 29 |
| Total | 29 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 23.7 years STANDARD_DEVIATION 5.36 |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 37 | 0 / 29 | 0 / 28 | 0 / 29 | 0 / 29 |
| other Total, other adverse events | 0 / 37 | 0 / 29 | 0 / 28 | 0 / 29 | 0 / 29 |
| serious Total, serious adverse events | 0 / 37 | 0 / 29 | 0 / 28 | 0 / 29 | 0 / 29 |
Outcome results
Primary
Tear Film Evaporation Rate
Tear film evaporation rate (amount of tears (grams or g) that evaporates over a surface area (m2) per hour (h)) assessment was performed using the VapoMeter as a non-invasive measurement of tear film evaporation over 10 seconds. Measurements were taken on both the right and left eyes after 8 hours of lens wear or no lens wear, as applicable. A higher evaporation rate can be a contributing factor to eye irritation and lens intolerance.
Time frame: Day 1, Hour 8, each product
Population: This analysis population includes all randomized subjects (Intent-to-Treat). To address the primary objective of comparing Lens vs. No Lens, results from all 3 study lenses are combined. Therefore, subjects (eyes) are counted multiple times in Lens group due to crossover design and number of eyes with non-missing response is reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lens | Tear Film Evaporation Rate | 120.88 gm^-2 h | Standard Deviation 45.563 |
| No Lens | Tear Film Evaporation Rate | 105.63 gm^-2 h | Standard Deviation 53.361 |