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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00344721
Recruitment Status : Unknown
Verified June 2006 by University of Texas Southwestern Medical Center.
Recruitment status was:  Recruiting
First Posted : June 27, 2006
Last Update Posted : June 27, 2006
Information provided by:

June 23, 2006
June 27, 2006
June 27, 2006
September 2004
Not Provided
Lipid biochemistry changes pre and post treatment with masked treatment
Same as current
No Changes Posted
Evaporametry and Fluorophometry changes pre and post treatment with masked treatment
Same as current
Not Provided
Not Provided
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
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
To determine the effect of Essential Fatty Acids (EFA’s) on Meibomian Gland lipids and aqueous tear production in patients with “dry eyes”.

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 will receive four oral doses of soft-gel capsules to be taken daily (QD). Omega-3 Fatty Acid tablet contains:

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

Patients on placebo will receive nutritional supplements 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 evaporometer; meibomian gland drop out determined by infrared photography and meibomian gland secretion for biochemical analysis.

Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Dry Eye Syndrome
Drug: Essential fatty acid supplement
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
June 2006
Not Provided

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.

Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Not Provided
Not Provided
University of Texas Southwestern Medical Center
Advanced Vision Research
Principal Investigator: James P. McCulley, M.D. University of Texas, Southwestern Medical Center at Dallas
University of Texas Southwestern Medical Center
June 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP