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 recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2006 by University of Texas Southwestern Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Advanced Vision Research
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00344721
First received: June 23, 2006
Last updated: NA
Last verified: June 2006
History: No changes posted
  Purpose

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


Condition Intervention Phase
Dry Eye Syndrome
Drug: Essential fatty acid supplement
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Lipid biochemistry changes pre and post treatment with masked treatment

Secondary Outcome Measures:
  • Evaporametry and Fluorophometry changes pre and post treatment with masked treatment

Estimated Enrollment: 36
Study Start Date: September 2004
Estimated Study Completion Date: June 2006
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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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.

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00344721

Contacts
Contact: Mike Molai, B.S. 214-648-4734 Mike.Molai@UTSouthwestern.edu

Locations
United States, Texas
University of Texas Southwestern Medical Center at Dallas Recruiting
Dallas, Texas, United States, 75390-8866
Contact: Mike Molai, B.S.    214-648-4734    Mike.Molai@UTSouthwestern.edu   
Principal Investigator: James P. McCulley, M.D.         
Sub-Investigator: Igor Butovich, Ph.D.         
Sub-Investigator: Joel D. Aronowicz, M.D.         
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00344721     History of Changes
Other Study ID Numbers: 082004-008
Study First Received: June 23, 2006
Last Updated: June 23, 2006
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on April 15, 2014