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
Recruitment status was Recruiting
|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|
- Lipid biochemistry changes pre and post treatment with masked treatment
- Evaporametry and Fluorophometry changes pre and post treatment with masked treatment
|Study Start Date:||September 2004|
|Estimated Study Completion Date:||June 2006|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00344721
|Contact: Mike Molai, B.S.||214-648-4734||Mike.Molai@UTSouthwestern.edu|
|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.|
|Principal Investigator:||James P. McCulley, M.D.||University of Texas, Southwestern Medical Center at Dallas|