HydroEye® is a dietary omega 3 fatty acid supplement that contains both EPA and DHA, as well as GLA and ALA in the form of black currant seed oil. It also has vitamins A, E, C, B6, and magnesium, many of which are involved in fatty acid metabolism. In 2013, Sheppard et al. tested HydroEye® in dry eye patients who were not contact lens wearers and found that symptoms and corneal smoothness improved in response to HydroEye® supplementation. To date, HydroEye® has not been assessed in patients with contact lens discomfort; therefore, the purpose of this clinical trial is to determine the efficacy of HydroEye® as a treatment for contact lens discomfort.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
31
This is an omega-3 fatty acids supplement.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Average Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score
The CLDEQ-8 is a contact lens specific symptoms survey, range = 0-37 with 37 being most symptomatic.
Time frame: 6 months
Average of Tear LTB4 Levels in Picograms Per Milliliter
If there is an adequate number of tear samples collected, LTB4 values will be tested with a biochemical assay to estimate eye surface inflammation. Pooled tears may be needed.
Time frame: Baseline, 6 months
Average Standardized Patient Evaluation of Eye Dryness (SPEED) Questionnaire Score
The SPEED is a dry eye specific symptoms survey, we are using the Rasch validated version; range = 0-28 with 28 being most symptomatic.
Time frame: 6 months
Number of Participants With a Non-zero Neuropathic Pain Symptom Inventory (NPSI) Questionnaire Score
NPSI is a pain specific symptoms survey; range = 0-100 with 100 being most symptomatic. The survey is used to assess serious and chronic pain; therefore the number of subjects with non-zero NPSI values was expected to be minimal, and change to non-zero values was measured in treatment and placebo arms.
Time frame: 6 months
Average Tear Breakup Time in Seconds
This is a measure of tear stability with higher values being better (seconds).
Time frame: 6 months
Average Schirmer I Test in mm
This is a measure of tear volume with higher values being better (0 mm - 35 mm).
Time frame: 6 months
Average Corneal Staining Score
This is a measure of eye irritation with higher values being worse (NEI scale with range of 0 to 15) with higher scores being worse.
Time frame: 6 months
Average Conjunctival Staining Score
This is a measure of eye irritation with higher values being worse (NEI scale with range of 0 to 18).
Time frame: 6 months
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