Dietary supplements and ocular (eye) comfort
Phase 3
Completed
- Conditions
- Ocular comfort including symptoms of dry eyeEye - Normal eye development and functionAlternative and Complementary Medicine - Other alternative and complementary medicine
- Registration Number
- ACTRN12610000991011
- Lead Sponsor
- Blackmores Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
Willing to comply with the dosage and study visit schedule
Contact lens wearers and non contact lens wearers
At least 18 years old
Exclusion Criteria
Current consumption of omega oil dietary supplements
Moderate or severe dry eye disease
Systematic disease that would preclude participants from safely ingesting dietary supplementation with omega oils
No S3 or above ocular medications
No use of any anticoagulants or blood thinning medications
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Subjective ocular comfort assessed using validated questionnaires (OCI, OSDI, SESOD, numerical rating scales, WHS, DEQ)[Baseline, 1 month, 3-month]
- Secondary Outcome Measures
Name Time Method Tear Film Stability, volume and composition assessed using NIBUT, osmometry, phenol red thread test[Baseline, 3-month];Lipid layer thickness and meibum composition using tearscope, validated grading scales and spectrum analysis[Baseline, 3-month];Cell and nerve morphology using impression cytology and confocal microscopy[Baseline, 3-month]