Anti-inflammatory treatments for contact lens discomfort
A proof-of-concept, placebo-controlled clinical trial to compare the efficacy of different formulations of omega-3 essential fatty acid supplements for treating contact lens discomfort
The University of Melbourne
80 participants
Apr 8, 2015
Interventional
Conditions
Summary
Contact lens discomfort is a multifactorial condition that is “characterised by episodic or persistent adverse ocular sensations related to contact lens wear, which can lead to decreased wearing time and discontinuation.” Currently, the main form of treatment for contact lens discomfort 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 the condition, for many patients they are inadequate in completely relieving symptoms. New and enhanced therapeutic treatments are therefore needed. Inflammation has been implicated in the pathogenesis of contact lens discomfort. The aim of this ‘proof-of-concept’, single site clinical trial is to evaluate the benefit of different formulations of omega-3 supplements for treating contact lens discomfort.
Eligibility
Inclusion Criteria1
- Existing contact lens wearers (for at least 6 months), with symptoms of contact lens discomfort (CLDEQ-8 score of at least 13).
Exclusion Criteria5
- 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
- A systemic medical condition where omega-3 supplements are contraindicated (e.g., bleeding disorders, diabetes, atrial fibrillation, familial immunocompromise, adenomatous polyposis, liver disease)
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Arm 1 (Treatment 1): trigylceride long-chain omega-3 oral supplement for 12 weeks (daily dose range: EPA: 500-1000mg, DHA 250-600mg) Arm 2 (Treatment 2): triglyceride long-and short-chain omega-3 oral supplement 2 for 12 weeks (daily dose range: EPA: 500-1000mg, DHA 250-600mg, ALA 500-1200mg) Arm 3 (Treatment 3): topical omega-3 eye drops for 12 weeks (dosed four times daily) Arm 4: placebo oral supplement for 12 weeks, followed by topical fluorometholone 0.1% eye drops (dosed three times daily) for 2 weeks (as a ‘gold standard’ anti-inflammatory therapy) Adherence to treatment will be monitored by assessing the return of unused study product at each visit.
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12615000173594