Omega 3 Supplementation and Ocular Surface Disease in Glaucoma
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|ClinicalTrials.gov Identifier: NCT01630551|
Recruitment Status : Withdrawn (No participants enrolled)
First Posted : June 28, 2012
Last Update Posted : February 28, 2017
Ocular surface disease (OSD) is a significant health problem that affects more than 10 million persons in the United States alone. OSD is highly prevalent among medically treated patients with glaucoma and is associated with the number of intraocular pressure (IOP)-lowering medications used.
The purpose of this study is to determine the potential effectiveness of anoritega-3 fatty acid nutritional supplement in the treatment of ocular surface disease associated"with the use of glaucoma eye drops
|Condition or disease||Intervention/treatment||Phase|
|Ocular Surface Disease||Dietary Supplement: Fishoil supplement Dietary Supplement: Olive Oil||Not Applicable|
Description of procedures/methods:
BASELINE VISIT Once the treating ophthalmologist has made the diagnosis of OSD, subjects will be asked to participate in the research study. Informed consent will be obtained for all subjects willing to participate in the study. Afterwards, the treating ophthalmologist will administer a dry eye questionnaire to each subject. After completion of the questionnaire, subjects will be given 90-day supply of the study drug/placebo. Based on a pre-determined randomization list, each subjects will be randomized to receive either the study medication (TheraTears nutritional supplementation) or a placebo drug (olive oil capsules). All subjects will be instructed to continue using artificial lubrication as needed while taking part in this study.
We hypothesize that therapy with an oral fish oil nutritional supplement containing 450mg EPA, 300 mg DHA, and 1000 mg flaxseed oil (TheraTears Nutrition; Advanced Vision Research, Woburn, MA) will decrease OSD-related symptoms as well as clinical markers associated with OSD (Schirmer test values, positive vital staining with lissamine green, fluorescein tear break-up time, and tear film osmolarity) when compared to administration of placebo.
FOLLOW-UP VISIT Approximately 90 days after the baseline visit, subjects are scheduled to come to the clinic for their routine• eye check. At that visit, subject's O.SD will be re-assessed by the same examination techniques as the baseline visit. After the examination, the questionnaire will be administered for a second time. The study drug will be discontinued at that visit and standard therapy for the subject's OSO, as deemed necessary by the treating ophthalmologist, will be instituted.
Statement of duration of subject participation:
Subject will be in the study for 3 months. There will be two visits, one is the baseline and second is the follow-up visit. All visits will coincide with their regular clinic visit. The total hours of study participation is no more than 2 hours.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Omega 3 fatty acid|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Omega-3 Fatty Acid Nutritional Supplementation in the Treatment of Ocular Surface Disease Associated With Intraocular Pressure-Lowering Medications|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||February 2017|
|Actual Study Completion Date :||February 2017|
Active Comparator: Fishoil nutritional supplement
90 day supply of daily oral administration of a fish oil nutritional supplement (TheraTears Nutrition; Advanced Vision Research, Woburn, MA)
Dietary Supplement: Fishoil supplement
1 capsule per day
Placebo Comparator: Olive oil capsules
90 day supply of a daily dose of placebo olive oil capsules
Dietary Supplement: Olive Oil
1 capsule per day
- Ocular Surface Disease Index Score [ Time Frame: 90 Days ]Ocular surface disease validated questionnaire regarding ocular symptoms
- Schirmer test score [ Time Frame: 90 days ]Scoring of tear production over 5 minutes
- Lissamine Green Staining Score [ Time Frame: 90 Days ]Ocular staining pattern for significant ocular surface disease
- Fluorescein tear break-up time [ Time Frame: 90 Days ]Clinical measure of tear film stability
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): NCT01630551
|United States, Illinois|
|Glaucoma Service, Department of Ophthalmology and Visual Science|
|Chicago, Illinois, United States, 60612|
|Principal Investigator:||Ahmad A Aref, MD||University of Illinois at Chicago College of Medicine|