A Placebo Controlled Double Masked Clinical Assessment Study of Essential Fatty Acid Supplement and Its Effect on Patients With Apparent Aqueous Deficient Dry Eye Syndrome

NCT00344721 | Completed

• 1 other identifier: 082004-008
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the effect of Essential Fatty Acids (EFA's) on Meibomian Gland lipids and aqueous tear production in patients with "dry eyes".

Conditions

Dry Eye Syndrome

Keywords

Meibomian Gland Syndrome; Blepharitis

Outcome Measures

Primary Outcomes (1)

• Lipid biochemistry changes: pre and post treatment

  Meibomian gland secretions will be subjected to biochemical analysis.

  3 months

Secondary Outcomes (2)

• Evaporometry changes: pre and post treatment

  3 months

• Fluorophotometry changes:pre and post treatment

  3 months

Study Arms (2)

EPA/DHA/flaxseed

ACTIVE COMPARATOR

Study patients in the active comparator arm will take four soft-gel capsules containing omega-3 fatty acids (a nutritional supplement) orally daily for 3 months. Each daily dose contains eicosapentaenoic acid (450 mg), docosahexaenoic acid (300 mg) and flaxseed oil (1000 mg).

Dietary Supplement: Omega-3 fatty acid supplement

Wheat germ oil

PLACEBO COMPARATOR

Study patients in the placebo arm will take four doses of soft-gel capsules containing wheat germ oil orally daily for 3 months.

Dietary Supplement: Placebo

Interventions

Omega-3 fatty acid supplement DIETARY_SUPPLEMENT

Participants receive four oral doses of soft-gel capsules to be taken daily (QD) for 3 months.

EPA/DHA/flaxseed

Placebo DIETARY_SUPPLEMENT

Participants receive four oral doses of soft-gel capsules containing wheat germ oil to be taken daily for 3 months.

Wheat germ oil

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Advanced Vision Research: collaborator

Study Sites (1)

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75390-8866, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Blepharitis

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Eyelid Diseases

Study Officials

• James P. McCulley, M.D.

  University of Texas, Southwestern Medical Center at Dallas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The active ingredient and placebo softgels appear identical and are supplied in identical containers for masking purposes. Study personnel performing study visit procedures are masked to group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & Chairman, David Bruton Jr. Chair in Ophthalmology

Model Details: Patients will be randomized to receive either omega-3 fatty acid or placebo soft-gel capsules.

Study Record Dates

• First Submitted: June 23, 2006
• First Posted: June 27, 2006
• Study Start: September 1, 2004
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: May 14, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)