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

Tracking Information
First Submitted Date ICMJE	June 23, 2006
First Posted Date ICMJE	June 27, 2006
Last Update Posted Date	May 14, 2018
Study Start Date ICMJE	September 2004
Actual Primary Completion Date	October 2008 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: May 7, 2018)	Lipid biochemistry changes: pre and post treatment [ Time Frame: 3 months ]; Meibomian gland secretions will be subjected to biochemical analysis.
Original Primary Outcome Measures ICMJE; (submitted: June 23, 2006)	Lipid biochemistry changes pre and post treatment with masked treatment
Change History	Complete list of historical versions of study NCT00344721 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: May 7, 2018)	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.
Original Secondary Outcome Measures ICMJE; (submitted: June 23, 2006)	Evaporametry and Fluorophometry changes pre and post treatment with masked treatment
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	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
Official Title ICMJE	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
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".
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 ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	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
Condition ICMJE	Dry Eye Syndrome
Intervention ICMJE	Dietary Supplement: Omega-3 fatty acid supplement Participants receive four oral doses of soft-gel capsules to be taken daily (QD) 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.
Study Arms	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). Intervention: Dietary Supplement: Omega-3 fatty acid supplement; 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. Intervention: Dietary Supplement: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: May 7, 2018)	42
Original Enrollment ICMJE; (submitted: June 23, 2006)	36
Actual Study Completion Date	October 2008
Actual Primary Completion Date	October 2008 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 90 Years (Adult, Older Adult)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00344721
Other Study ID Numbers ICMJE	082004-008
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Plan to Share IPD: No
Responsible Party	James McCulley, University of Texas Southwestern Medical Center
Study Sponsor ICMJE	University of Texas Southwestern Medical Center
Collaborators ICMJE	Advanced Vision Research
Investigators ICMJE	Principal Investigator: James P. McCulley, M.D. University of Texas, Southwestern Medical Center at Dallas
PRS Account	University of Texas Southwestern Medical Center
Verification Date	May 2018
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP