Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00344721
Status:
COMPLETED
Last Update Posted:
2018-05-14
First Post:
2006-06-23
Brief 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
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine the effect of Essential Fatty Acids EFAs 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 EFAs 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 Patients 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
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 EFAs 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 Patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None