Effects of Supplementation With PUFAs and Antioxidants for Contact Lens Discomfort

Phase 4

Terminated

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
HydroEye®	HydroEye®	Subjects will take a total of four capsules daily, with meals (two capsules taken orally, twice a day).
Placebo	HydroEye®	Subjects will take a total of four capsules daily, with meals (two capsules taken orally, twice a day).

Primary Outcome Measures

Name	Time	Method
Average Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score	6 months	The CLDEQ-8 is a contact lens specific symptoms survey, range = 0-37 with 37 being most symptomatic.

Secondary Outcome Measures

Name	Time	Method
Average of Tear LTB4 Levels in Picograms Per Milliliter	Baseline, 6 months	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.
Average Standardized Patient Evaluation of Eye Dryness (SPEED) Questionnaire Score	6 months	The SPEED is a dry eye specific symptoms survey, we are using the Rasch validated version; range = 0-28 with 28 being most symptomatic.
Number of Participants With a Non-zero Neuropathic Pain Symptom Inventory (NPSI) Questionnaire Score	6 months	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.
Average Tear Breakup Time in Seconds	6 months	This is a measure of tear stability with higher values being better (seconds).
Average Schirmer I Test in mm	6 months	This is a measure of tear volume with higher values being better (0 mm - 35 mm).
Average Corneal Staining Score	6 months	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.
Average Conjunctival Staining Score	6 months	This is a measure of eye irritation with higher values being worse (NEI scale with range of 0 to 18).