Tokyo, Nov. 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059789) titled 'Efficacy of Omega-3 Supplementation in Patients with Dry Eyes Disease: An Interventional Study' on Nov. 15.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Atma Jaya Catholic University of Indonesia
Condition:
Condition - Dry eyes disease
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate whether omega-3 supplementation is effective in improving the signs and symptoms of dry eye disease compared to standard therapy
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Intervention Group (Optimax O3 - Omega-3 Supplementation): Participants in the intervention group will receive Optimax O3 at a dose of 2 capsules once daily for 12 weeks. Each capsule contains EPA 180 mg, DHA 120 mg, Lutein 10 mg, and Lycopene 2 mg. Participants record daily intake in a diary and remaining capsules returned at each follow-up visit for compliance verification. The supplementation is given in addition to standard therapy
Interventions/Control_2 - Control Group: Control group will receive standard therapy only, consisting of artificial tears or hyaluronic acid or corticosteroid eye drops according to routine clinical practice. No Omega-3 supplementation will be given in the control group.
Eligibility:
Age-lower limit - 17
years-old
=
Gender - Male and Female
Key inclusion criteria - 1. Age 17-69 years old
2. Diagnosed with dry eyes disease
3. Willing to participate and provide informed consent
Key exclusion criteria - 1. Declines to participate in the study
2. Patient with type 2 diabetes mellitus
3. History of ocular surgery (post-operative patients within the past 12 months)
Target Size - 22
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2024 Year 03 Month 18 Day
Date of IRB - 2024 Year 03 Month 18 Day
Anticipated trial start date - 2024 Year 04 Month 18 Day
Last follow-up date - 2024 Year 11 Month 28 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068363
Disclaimer: Curated by HT Syndication.
