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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

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ClinicalTrials.gov Identifier: NCT00344721
Recruitment Status : Completed
First Posted : June 27, 2006
Last Update Posted : May 14, 2018
Sponsor:
Collaborator:
Advanced Vision Research
Information provided by (Responsible Party):
James McCulley, University of Texas Southwestern Medical Center

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".

Condition or disease Intervention/treatment Phase
Dry Eye Syndrome Dietary Supplement: Omega-3 fatty acid supplement Dietary Supplement: Placebo Not Applicable

Detailed Description:

The effects of essential fatty acids on Meibomian Gland lipid composition and aqueous tear production may be greater than previously thought. Dry Eye syndromes afflict millions of people worldwide, more than 10 million in the United States alone. Typically, symptoms that are associated with dry eye disease include ocular burning, foreign body sensation, photophobia and other symptoms that result in overall chronic discomfort in patients. Unfortunately, the effects of Essential Fatty Acids on aqueous tears or Meibomian lipids (AT) have not been established to date. The purpose of this study is to better understand the role essential fatty acids play in the maintenance of meibomian gland lipids and overall production or retention of aqueous tears.

Patients diagnosed with dry eye syndrome will be selected to participate in the study. Once qualified to take part in the trial, participants randomized to the active comparator arm will receive four oral doses of soft-gel capsules to be taken daily (QD). Omega-3 Fatty Acid daily content:

EPA (eicosapentaenoic acid) Dose: 450mg DHA (docosahexaenoic acid) Dose: 300mg Flaxseed Oil (organic) Dose: 1000mg

Patients on placebo will receive nutritional supplement capsules containing wheat germ oil but no EFA's. During the trial, patient will be encouraged not to change their diet, use of topical ophthalmics and systemic therapies other than the use of study treatment. Patient's topical therapy will be standardized after identification exam so that all patients will use TheraTears™ four times daily. Patients will be directed to take the masked capsules in the following manner: 4 soft-gels in the morning.

Masked medication, TheraTears™ and randomization tables will be provided by sponsor.

Subject will have the following tests performed during the first visit (before initiating treatment) and follow-up (after three months of treatment) visit,: a complete eye exam, (vital staining of ocular surface and tear break-up time); completion of questionnaires: Ocular Surface Index (OSDI) and Patient Symptomology Questionnaire will be presented to the patient to review and answer at both visits: Before initiating treatment and after three months on therapy, meibography, fluorophotometry will be performed in order to measure tear volume, flow and turnover, Schirmer test; and tear evaporation using an evaporimeter; meibomian gland drop out determined by infrared photography and meibomian gland secretion for biochemical analysis.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be randomized to receive either omega-3 fatty acid or placebo soft-gel capsules.
Masking: Double (Participant, Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2004
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: EPA/DHA/flaxseed
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
Participants receive four oral doses of soft-gel capsules to be taken daily (QD) for 3 months.

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




Primary Outcome Measures :
  1. Lipid biochemistry changes: pre and post treatment [ Time Frame: 3 months ]
    Meibomian gland secretions will be subjected to biochemical analysis.


Secondary Outcome Measures :
  1. Evaporometry changes: pre and post treatment [ Time Frame: 3 months ]
    Tear evaporation rate will be measured using an evaporometer.

  2. Fluorophotometry changes:pre and post treatment [ Time Frame: 3 months ]
    Clearance rate of the topically applied dye fluorescein will be measured by fluorophotometry.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: Patient over 18 years of age, patient willing and able to comply with the protocol, no planned changes in diet, topical or systemic drugs during course of study. Ocular symptoms consistent with dry eye of insidious onset and greater than three months duration. Ocular surface vital staining consistent with aqueous deficient dry eyes with less than +1 conjunctival injection and no more than minimal lid inflammation -

Exclusion Criteria: Any patient that uses topical eye drops other than artificial tears. Any patient with punctual occlusion or punctual plugs. Patients with active ocular infection or inflammatory disease, history of herpetic keratitis, history of retinal detachment, concurrent contact lens use during the trial period, ocular surgery within the past six months, patients with glaucoma, anterior membrane dystrophy, active trichiasis or any eyelid globe malposition abnormality, e.g., entropion, ectropion, etc. Patients with Epiphora (excessive tearing). Moreover, patients taking medications known to effect aqueous tear production or meibomian secretions. Patient must not have participated in (or be currently participating in) any investigational therapeutic drug or device trial within the previous 30 days prior to their start date for this trial. In addition, any patient suffering from organic brain syndromes or major psychiatric disorder that would interfere with compliance or subjective reporting will be discouraged from participating in this trial.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00344721


Locations
United States, Texas
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390-8866
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Advanced Vision Research
Investigators
Principal Investigator: James P. McCulley, M.D. University of Texas, Southwestern Medical Center at Dallas

Responsible Party: James McCulley, Professor & Chairman, David Bruton Jr. Chair in Ophthalmology, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00344721     History of Changes
Other Study ID Numbers: 082004-008
First Posted: June 27, 2006    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by James McCulley, University of Texas Southwestern Medical Center:
Meibomian Gland Syndrome
Blepharitis

Additional relevant MeSH terms:
Syndrome
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Disease
Pathologic Processes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases