Omega-3 supplements for treating dry eye disease

A proof-of-concept, placebo-controlled clinical trial to compare the efficacy of different forms of omega-3 essential fatty acid supplements for treating mild-to-moderate dry eye disease

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614001019695

Enrollment

Registered

2014-09-22

Start date

2014-11-05

Completion date

2015-08-18

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Dry eye disease is a common condition, affecting up to 30% of adults. Common symptoms of dry eye disease include eye irritation (e.g., burning, grittiness, scratchiness, wateriness) and/or fluctuations in vision. Currently, the main form of treatment for dry eye disease is the use of artificial tears (lubrication drops), which can assist in reducing these symptoms by supplementing the deficient tear fluid. However, as artificial tears fail to address the underlying cause of dry eye disease, for many patients they are inadequate in completely relieving symptoms. New and enhanced therapeutic treatments are therefore needed. Inflammation plays an important role in the development of dry eye disease. There is growing scientific evidence that dietary supplementation with omega-3 essential fatty acids, may be of benefit in reducing inflammation throughout the body, including in the eye. A well recognised source of omega-3s is fish oil, which has undergone some preliminary investigations in relation to treating dry eye disease, however further research is needed to substantiate these findings. The aim of this ‘proof-of-concept’, single site clinical trial is to evaluate the benefit of phospholipid form omega-3 supplements for the treatment of dry eye disease, and whether this form of omega-3 provides any benefit over triglyceride omega-3s. The effects of both forms of omega-3 supplements will be compared with a control group, who will consume an olive oil supplement.

Interventions

Arm 1 (Treatment 1): triglyceride form omega-3 oral supplement (1000mg EPA + 500mg DHA per day) for three months. Arm 2 (Treatment 2): phospholipid form omega-3 oral supplement (945mg EPA + 510mg DHA per day) for three months. Adherence to treatment will be monitored by assessing the return of unused capsules at monthly visits.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Mild-to-moderate dry eye symptoms (OSDI score: 18-65) and tear osmolarity of at least 316mOsm/L in at least one eye

Exclusion criteria

Co-morbid ocular pathology (e.g., ocular infection, intra-ocular inflammation) Uncontrolled systemic disease Known or suspected allergy to fish/seafood, nuts, oil or gelatin Current medication with oral omega-3 supplements Contact lens wear within one month prior to Day 1 or intended wear of contact lenses over the course of the study A systemic medical condition where omega-3 supplements are contraindicated (e.g., bleeding disorders, diabetes, atrial fibrillation, familial immunocompromise, adenomatous polyposis, liver disease.)

Outcome results