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
|Condition or disease||Intervention/treatment||Phase|
|Dry Eye Syndrome||Dietary Supplement: Omega-3 fatty acid supplement Dietary Supplement: Placebo||Not Applicable|
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|
|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)|
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.
|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|
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.
- Lipid biochemistry changes: pre and post treatment [ Time Frame: 3 months ]Meibomian gland secretions will be subjected to biochemical analysis.
- Evaporometry changes: pre and post treatment [ Time Frame: 3 months ]Tear evaporation rate will be measured using an evaporometer.
- Fluorophotometry changes:pre and post treatment [ Time Frame: 3 months ]Clearance rate of the topically applied dye fluorescein will be measured by fluorophotometry.
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
|United States, Texas|
|University of Texas Southwestern Medical Center at Dallas|
|Dallas, Texas, United States, 75390-8866|
|Principal Investigator:||James P. McCulley, M.D.||University of Texas, Southwestern Medical Center at Dallas|