Tokyo, Nov. 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059836) titled 'Are dry eye patients with low omega-3 index the beneficiaries of omega-3 fatty acids supplements?' on Nov. 20.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - IGMC Shimla, HP, India
Condition:
Condition - Dry eye
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Does omega 3 fatty acids benefit dry eye patients with omega 3 index below 4%?
Basic objectives2 - Others
Intervention:
Interventions/Control_1 - Four capsules each containing 325 mg of EPA and 175 mg of DHA, totalling 1300 mg of EPA and 700 mg of DHA per day for 6 months.
Interventions/Control_2 - Olive oil capsules comprising 70% oleic acid, 18% linoleic acid, and 12% palmitic acid twice daily for 6 months
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - Symptomatic dry eye patients with omega-3 index less than 4%
Key exclusion criteria - Current ocular infection
recent refractive surgery
allergic conjunctivitis
contact lens use
herpetic eye disease
diabetes
liver diseases
inability to swallow soft gel capsules,
aspirin or anti-coagulant therapy
allergy to fluorescein
Target Size - 100
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2025 Year 06 Month 20 Day
Date of IRB - 2025 Year 06 Month 10 Day
Anticipated trial start date - 2025 Year 11 Month 15 Day
Last follow-up date - 2026 Year 06 Month 09 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068428
Disclaimer: Curated by HT Syndication.
