Lid Wiper Epitheliopathy
Conditions
Keywords
Lid Wiper Epitheliopahty, Coefficient of Friction
Brief summary
This study examines the development of Lid Wiper Epitheliopathy (LWE) in individuals fit with contact lenses having difference coefficients of friction (CoF)
Detailed description
The primary study objectives are to determine the amount of Lid Wiper Epitheliopathy (LWE) induced in subjects after contact lens fitting that do not have LWE at study enrollment. Subjects in the trial will be fit in 2 contact lenses with different coefficients of friction (CoF). One eye will be fit in a contact lens with a low coefficient of friction (Acuvue Oasys®, Johnson & Johnson Vision, Jacksonville FL) while the contralateral eye will be fit in a contact lens with a high CoF (Air Optix® Night & Day® Aqua, Ft. Worth, TX), as reported in the scientific literature. The eye receiving each lens will be assigned randomly. The presence of LWE will be assessed at 2 different time points, approximately 2 hours after contact lens fitting and approximately after 7 days of contact lens wear.
Interventions
DEVICEAcuvue Oasys
FDA approved contact lens, fit for daily wear
DEVICEAir Optix Night & Day Aqua
FDA approved contact lens, fit for daily wear
Sponsors
University of Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Subjects will be masked to the contact lens brand fit in each eye. The subject's Lid Wiper Epitheliopathy will be graded using photographs of the eyelid, where the grader is masked to the lens type in each eye.
Intervention model description
Subjects will be fit in a different contact lens brand in each eye. Assignment of the contact lens to each eye will be randomized. One eye will be fit in a contact lens with a low coefficient of friction while the contralateral eye will be fit in a contact lens with a high coefficient of friction.
Eligibility
Sex/Gender
ALL
Age
18 Years to 46 Years
Healthy volunteers
Yes
Inclusion criteria
1. Must be able to read and understand the study informed consent 2. Must be a minimum of 18 years of age and less than 46 years of age at study enrollment 3. Must be healthy non-soft contact lens wearers (neophytes), or experienced contact lens wearers that have not worn their contact lenses for a minimum of 7 days 4. Have a spherical equivalent refractive error between -0.75 to -6.50DS at the spectacle plane 5. The subject must be able to attend study visits at the prescribed visit times and adhere to the study instructions
Exclusion criteria
1. Pregnant and/or lactating females by self-report 2. Presence of current LWE on the upper eyelid (\>0.5 in height or width) 3. Has greater than -1.00DC of refractive cylinder 4. Has greater than 1.00D of anisometropia 5. Is aphakic 6. Has clinically significant corneal or conjunctival staining that would prevent contact lens fitting, as assessed with sodium fluorescein dye 7. Has significant ocular surface disease (e.g. Sjögrens Disease, Stevens-Johnson Syndrome, etc.) or significant Dry Eye Syndrome 8. Has clinically significant corneal vascularization or central corneal scaring 9. Has active ocular surface infection (e.g. conjunctivitis) 10. Has a positive history of eyelid surgery or trauma 11. Has a positive history of refractive surgery 12. Takes medications that significantly impact contact lens comfort and/or ocular surface health 13. Has taken part in another contact lens or contact lens solution clinical trial within the last 7 days 14. Is unwilling to have eyes photographed or video recorded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lid Wiper Epitheliopathy | One week post contact lens fitting | Lid Wiper Staining of the Upper Eyelid. The lid wiper region of the eyelid is the portion of the marginal conjunctival epithelium that moves across the ocular surface or contact lens during blinking. Participants were classified according to their lid wiper epitheliopathy grade for each eye using the following scale: None = 0, Mild = 0.25 - 1.00, Moderate = 1.25 - 2.00, and Severe = 2.25 - 3.00. Grades range from 0 to 3, where higher grades indicate worsening lid wiper epitheliopathy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lid Wiper Epitheliopathy | 2 hours post contact lens fitting | Lid Wiper Staining of the Upper Eyelid. The lid wiper region of the eyelid is the portion of the marginal conjunctival epithelium that moves across the ocular surface or contact lens during blinking. Participants were classified according to their lid wiper epitheliopathy grade for each eye using the following scale: None = 0, Mild = 0.25 - 1.00, Moderate = 1.25 - 2.00, and Severe = 2.25 - 3.00. Grades range from 0 to 3, where higher grades indicate worsening lid wiper epitheliopathy. |
Countries
United States
Participant flow
Pre-assignment details
The study was a contralateral fitting study with one eye receiving the Acuvue Oasys and the contralateral eye receiving the Air Optix Night and Day. Forty eyes of twenty subjects were examined and completed the study
Participants by arm
| Arm | Count |
|---|---|
| Contact Lenses Forty (40) eyes of twenty subjects were examined. One eye of each subject was assigned either the low coefficient of friction lens and the other eye received the high coefficient of friction lens. Lens/eye assignment occurred per the study randomization schedule. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Contact Lenses |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Age, Continuous | 23.95 years STANDARD_DEVIATION 2.31 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Refractive Error: Left Eye | -1.94 Diopters STANDARD_DEVIATION 1.75 |
| Refractive Error: Right Eye | -2.19 Diopters STANDARD_DEVIATION 1.46 |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Lid Wiper Epitheliopathy
Lid Wiper Staining of the Upper Eyelid. The lid wiper region of the eyelid is the portion of the marginal conjunctival epithelium that moves across the ocular surface or contact lens during blinking. Participants were classified according to their lid wiper epitheliopathy grade for each eye using the following scale: None = 0, Mild = 0.25 - 1.00, Moderate = 1.25 - 2.00, and Severe = 2.25 - 3.00. Grades range from 0 to 3, where higher grades indicate worsening lid wiper epitheliopathy.
Time frame: One week post contact lens fitting
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Eye 1: Low Coefficient of Friction | Lid Wiper Epitheliopathy | 0.63 score on a scale |
| Eye 2: High Coefficient of Friction | Lid Wiper Epitheliopathy | 0.25 score on a scale |
Secondary
Lid Wiper Epitheliopathy
Lid Wiper Staining of the Upper Eyelid. The lid wiper region of the eyelid is the portion of the marginal conjunctival epithelium that moves across the ocular surface or contact lens during blinking. Participants were classified according to their lid wiper epitheliopathy grade for each eye using the following scale: None = 0, Mild = 0.25 - 1.00, Moderate = 1.25 - 2.00, and Severe = 2.25 - 3.00. Grades range from 0 to 3, where higher grades indicate worsening lid wiper epitheliopathy.
Time frame: 2 hours post contact lens fitting
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Eye 1: Low Coefficient of Friction | Lid Wiper Epitheliopathy | 0.75 score on a scale |
| Eye 2: High Coefficient of Friction | Lid Wiper Epitheliopathy | 0.13 score on a scale |