Omega-3 supplements for treating dry eye disease
Phase 2
Completed
- Conditions
- Dry eye diseaseEye - Diseases / disorders of the eye
- Registration Number
- ACTRN12614001019695
- Lead Sponsor
- The University of Melbourne
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
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.)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patient symptoms: ocular surface disease index (OSDI) survey score, a quantitative and validated survey instrument to grade the severity of dry eye disease.[Change in OSDI score between Days 1 and 90.];Tear osmolarity: electrolyte concentration of the tears (measured in mOsm/L using the TearLab system (TearLab Corporation Pty Ltd), which is currently considered a gold standard for dry eye assessment).[Change in tear osmolarity between Days 1 and 90.]
- Secondary Outcome Measures
Name Time Method