Effects of Supplementation With PUFAs and Antioxidants for Contact Lens Discomfort

Inclusion Criteria:

1. Age ≥18 years

2. Provide informed consent and authorization to disclose protected health information

3. Willing to follow study protocol

4. Habitual, contact lens-corrected visual acuity of at least 20/30 in each eye

5. Wear soft contact lenses as daily wear for at least 6 hours per day and at least 5days per week for the past 30 days

6. Have at least a 2-hour difference between overall wear time and comfortable weartime of contact lenses

7. Have symptoms consistent with Contact Lens Dry Eye based on CLDEQ-8 (score ≥ 12)

8. Increased severity of dry eye symptoms with contact lens wear by at least 25% asdetermined by patient self-report

9. Clinical assessment that contact lens material, fit, prescription, and care systemare not reasons for contact lens discomfort

10. Demonstrate at least 80% compliance in completion of daily electronic diary (submitted through Qualtrics Research Suite) between V1 and V2

11. Willing to discontinue use of any current dry eye treatment (including use ofcommercial hygiene masks, and except for artificial tears) for 4 weeks beforerandomization and during the course of the 6-month study.

Exclusion Criteria:

1. Meibomian gland dropout ≥75% in either eyelid

2. 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 thecourse of the study

3. Any systemic disease known to be associated with dry eye

4. Any significant ocular surface abnormality that could be associated with ocularsurface discomfort, such as ectropion, entropion, trichiasis, infection, severeallergic conjunctivitis, severe eyelid inflammation, etc.

5. Any overnight wear of contact lenses or use of daily disposable contact lenses

6. Any previous corneal surgery, including all types of corneorefractive surgery

7. Have temporary and/or permanent punctal plugs inserted

8. Use of supplemental fish oil, or seed oils from borage, evening primrose, seabuckthorn, flaxseed, or black currant within the last 60 days

9. Routine, usual dietary intake of more than 8 oz. of cold-water fatty fish (tuna,salmon, mackerel, sea bass, sardines or herring) per week).

10. Use of anticoagulant therapy or regular, daily use of aspirin, NSAIDs, or steroidmedications within the past 30 days, or a history of easy bruising

11. Allergy or intolerance to fish or any ingredients contained in the active or placeboformulas [See appendix or ingredient list]

12. Participation in a clinical trial in the past 30 days

13. Current pregnancy or breast feeding as indicated by self-report