Dietary Supplementation on Tear Secretion and Inflammation in DES

NCT06738446 | Completed

• 1 other identifier: CSI-20199
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to explore the effect of supplementation of fish oil, lutein and zeaxanthin on the symptoms of dry eye syndrome, antioxidant capacity, oxidative stress and anti-inflammatory capacity in DES patients., it aims to answer are: To evaluate the effects of a 12-week multicomponent dietary supplementation (capsule content are eicosapentaenoic acid 45 mg, docosahexaenoic acid 30 mg, lutein 30 mg, and zeaxanthin1.8 mg)on symptoms of dry eye syndrome, oxidative stress, antioxidant capacity, and inflammation. To investigate the relationships between dry eye symptoms, oxidative stress, antioxidant capacity, and inflammation. Participants will be randomly assigned to control group (n = 50) and supplement group (n = 50) and white pomegranate extract group (n = 50) for 12 weeks. Participants will complete assessments of tear secretion, antioxidant capacity, and ocular surface inflammation.

Conditions

Dry Eye Syndrome (DES)

Keywords

Dry eye syndrome; inflammation; oxidative stress; fish oil; lutein; zeaxanthin

Outcome Measures

Primary Outcomes (1)

• Ocular Surface Disease Index

  We aim to improve the symptoms of dry eye disease in patients by administering dietary supplements

  12 weeks

Study Arms (2)

control group

NO INTERVENTION

This group is used only as a control.

Multicomponent Dietary Supplement group

EXPERIMENTAL

45 mg/day EPA, 30 mg/day DHA, 30 mg/day lutein, and 1.8 mg/day zeaxanthin

Dietary Supplement: Multicomponent dietary supplement group

Interventions

Multicomponent dietary supplement group DIETARY_SUPPLEMENT

Participants in supplement group were asked to take a capsule content are eicosapentaenoic acid 45 mg, docosahexaenoic acid 30 mg, lutein 30 mg, and zeaxanthin1.8 mg every day for 12 weeks

Multicomponent Dietary Supplement group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged between 20 and 80 years,
• moderate or above severity of dry eye syndrome.

You may not qualify if:

• undergoing ophthalmic surgery within the past three months,
• autoimmune diseases,
• ocular allergies,
• consumption of fish oil or antioxidant supplements within the past three months, and
• pregnant or lactating women.

Sponsors & Collaborators

• Shih Chien Huang: lead
• Far East Bio-Tec Co., Ltd: collaborator

Study Sites (1)

Chung Shan Medical University Hospital

Taichung, 402, Taiwan

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Inflammation

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shih-Chien Huang, Dr

  Chung Shan Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 17, 2024
• Study Start: September 27, 2021
• Primary Completion: April 2, 2022
• Study Completion: June 14, 2022
• Last Updated: May 14, 2025

Record last verified: 2025-05

Locations

TW (1)