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Omega 3 fatty acids in dry eye syndrome

Omega 3 fatty acids in evaporative dry eye! Are they ineffective? - O3FAs in evaporative dry eye

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000049192
Enrollment
450
Registered
2023-06-01
Start date
2022-06-10
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Syndrome

Interventions

The O3FA group received 4 capsules, each containing 180 mg of EPA and 120 mg docosahexaenoic acid (DHA), twice daily for 180 days (1,440 mg of EPA +960 mg DHA/day). The placebo group received 4 capsu

Sponsors

Nil
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: A letter was sent to the supervisors in the health management section of regional call-centers, universities, and information technology (IT) companies to explain the study purpose and to request participation in the study. Three universities, three call-centers, and four IT companies responded and agreed to participate in the study; after reviewing the protocol and potential risks and benefits, permission was granted to conduct the study among employees who were willing. Employees were invited by e-mail to answer a questionnaire; this included information such as demographic characteristics, dietary habits (vegetarian / fish consumer), symptoms experienced, total working hrs, and average hrs spent in VDT work each day during the past year. A maximum of three e-mail reminders were sent. Employees who completed the questionnaire were requested to attend a dry eye clinic for ophthalmic work-up and blood tests. Symptomatic VDT users (those experiencing dry eye symptoms) were identified, and the subjects were enrolled, and grading of dry eye disease was done based on their response to the Indian Dry Eye questionnaire called the Dry Eye Scoring System (DESS), a questionnaire of common symptoms of dry eye

Exclusion criteria

Exclusion criteria: Patients with allergic conjunctivitis, history of laser in situ keratomileusis, and contact lens wear, or other causes of dry eye in the office-going population, software professionals, or university students were excluded from the study. Patients with inability to swallow soft-gel capsules, those on regular course of aspirin or anticoagulants (cyclooxygenase-2 inhibitors), and those allergic to fluorescein were also excluded. Systemic (tetracyclines and corticosteroids) or topical medications (other than artificial tear supplements) that could affect the tear film or meibomian gland functions (betablockers, benzodiazepines, and antihistamines) were discontinued 3 weeks before intervention. Moreover, patients were instructed not to use artificial tear preparations, 2 hr before testing.

Design outcomes

Primary

MeasureTime frame
The primary outcome measure was the change from baseline in omega-3 index (a measure of the amount of EPA and DHA in the blood, specifically the red blood cell membranes).

Secondary

MeasureTime frame
Secondary outcome measures were subjective dry eye symptoms (a reduction from baseline representing an improvement). Other outcome measures were a change in tear film osmolarity, the Schirmer test value (increase in the amount of wetting representing an improvement), TBUT (increased time [in sec] representing an improvement), and Nelson grade at day 45 (reduction in the grade representing an improvement). The relation between the time spent in front of the VDT (predictor variable) and the outcome variables was also evaluated.

Countries

Asia(except Japan)

Contacts

Public ContactAnuj Mehra

Anuj safety Delhi

anujsafety@gmail.com9891277776

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026