None listed
Conditions
Brief 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.
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)
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.
Sponsors
The University of Melbourne
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
No
Inclusion criteria
Existing contact lens wearers (for at least 6 months), with symptoms of contact lens discomfort (CLDEQ-8 score of at least 13).
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 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
None listed