Anti-inflammatory treatments for contact lens discomfort
Phase 2
Completed
- Conditions
- Contact lens discomfortEye - Diseases / disorders of the eye
- Registration Number
- ACTRN12615000173594
- Lead Sponsor
- The University of Melbourne
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 80
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patient symptoms: contact-lens dry eye questionnaire 8 (CLDEQ-8) survey score, a quantitative and validated survey instrument to grade the severity of contact lens discomfort. [Change in CLDEQ-8 score between Days 1 and 84.];Tear osmolarity (tear electrolyte concentration), measured in mOsm/L using the TearLab system. [Change in tear osmolarity between Days 1 and 84.];Tear inflammatory cytokine levels using multiplex-CBA analysis techniques.[Change in tear cytokine levels between Days 1 and 84. ]
- Secondary Outcome Measures
Name Time Method