Effects of Supplementation With PUFAs and Antioxidants for Contact Lens Discomfort

The University of Alabama at Birmingham

Status and phase

Terminated

Phase 4

Conditions

Dry Eye

Contact Lens Complication

Treatments

Drug: HydroEye®

Study type

Interventional

Funder types

Other

Identifiers

NCT04163328

000526521

Details and patient eligibility

About

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.

Enrollment

31 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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