Effects of Supplementation With PUFAs and Antioxidants for Contact Lens Discomfort

Study Overview
=================
Brief Summary
-----------------
HydroEye® is a dietary 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.

Official Title
-----------------
Effects of Supplementation With PUFAs and Antioxidants for Contact Lens Discomfort

Conditions
-----------------
Dry Eye, Contact Lens Complication

Intervention / Treatment
-----------------
* Drug: HydroEye®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years Provide informed consent and authorization to disclose protected health information Willing to follow study protocol Habitual, contact lens-corrected visual acuity of at least 20/30 in each eye Wear soft contact lenses as daily wear for at least 6 hours per day and at least 5 days per week for the past 30 days Have at least a 2-hour difference between overall wear time and comfortable wear time of contact lenses Have symptoms consistent with Contact Lens Dry Eye based on CLDEQ-8 (score ≥ 12) Increased severity of dry eye symptoms with contact lens wear by at least 25% as determined by patient self-report Clinical assessment that contact lens material, fit, prescription, and care system are not reasons for contact lens discomfort Demonstrate at least 80% compliance in completion of daily electronic diary (submitted through Qualtrics Research Suite) between V1 and V2 Willing to discontinue use of any current dry eye treatment (including use of commercial hygiene masks, and except for artificial tears) for 4 weeks before randomization and during the course of the 6-month study. Exclusion Criteria: Meibomian gland dropout ≥75% in either eyelid Any changes to the contact lens material, fit, prescription, or care system in the 30 days preceding enrollment or anticipates needing to make changes during the course of the study Any systemic disease known to be associated with dry eye Any significant ocular surface abnormality that could be associated with ocular surface discomfort, such as ectropion, entropion, trichiasis, infection, severe allergic conjunctivitis, severe eyelid inflammation, etc. Any overnight wear of contact lenses or use of daily disposable contact lenses Any previous corneal surgery, including all types of corneorefractive surgery Have temporary and/or permanent punctal plugs inserted Use of supplemental fish oil, or seed oils from borage, evening primrose, sea buckthorn, flaxseed, or black currant within the last 60 days Routine, usual dietary intake of more than 8 oz. of cold-water fatty fish (tuna, salmon, mackerel, sea bass, sardines or herring) per week). Use of anticoagulant therapy or regular, daily use of aspirin, NSAIDs, or steroid medications within the past 30 days, or a history of easy bruising Allergy or intolerance to fish or any ingredients contained in the active or placebo formulas [See appendix or ingredient list] Participation in a clinical trial in the past 30 days Current pregnancy or breast feeding as indicated by self-report

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HydroEye®<br>Subjects will take a total of four capsules daily, with meals (two capsules taken orally, twice a day). | Drug: HydroEye®<br>* This is an omega-3 fatty acids supplement.<br>|
| Placebo Comparator: Placebo<br>Subjects will take a total of four capsules daily, with meals (two capsules taken orally, twice a day). | Drug: HydroEye®<br>* This is an omega-3 fatty acids supplement.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contact Lens Dry Eye Questionnaire (CLDEQ-4) | The CLDEQ-4 is a contact lens specific symptoms survey, we are using the Rasch validated version; range = 0-18 with 18 being most symptomatic. | Mean change at 6 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear LTB4 Levels | LTB4 values will be tested with a biochemical assay to estimate eye surface inflammation. | Mean change at 6 months. | 
| Standardized Patient Evaluation of Eye Dryness (SPEED) Questionnaire | The SPEED is a dry eye specific symptoms survey, we are using the Rasch validated version; range = 0-28 with 28 being most symptomatic. | Mean change at 6 months. | 
| Neuropathic Pain Symptom Inventory (NPSI) Questionnaire | NPSI is a pain specific symptoms survey; range = 0-100 with 100 being most symptomatic. | Mean change at 6 months. | 
| Tear Breakup Time | This is a measure of tear stability with higher values being better (seconds). | Mean change at 6 months. | 
| Schirmer I Test | This is a measure of tear volume with higher values being better (0 mm - 35 mm). | Mean change at 6 months. | 
| Corneal Staining | This is a measure of eye irritation with higher values being worse (NEI scale with range of 0 to 15). | Mean change at 6 months. | 
| Conjunctival Staining | This is a measure of eye irritation with higher values being worse (NEI scale with range of 0 to 18). | Mean change at 6 months. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HydroEye®, Contact Lens Discomfort, Dry Eye, Supplement