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Omega 3 Supplementation and Ocular Surface Disease in Glaucoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01630551
Recruitment Status : Withdrawn (No participants enrolled)
First Posted : June 28, 2012
Last Update Posted : February 28, 2017
American Glaucoma Society
Information provided by (Responsible Party):
Ahmad A. Aref, MD, University of Illinois at Chicago

Brief Summary:

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

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Omega 3 fatty acid
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Ocular Surface Disease Index Score [ Time Frame: 90 Days ]
    Ocular surface disease validated questionnaire regarding ocular symptoms

Secondary Outcome Measures :
  1. Schirmer test score [ Time Frame: 90 days ]
    Scoring of tear production over 5 minutes

  2. Lissamine Green Staining Score [ Time Frame: 90 Days ]
    Ocular staining pattern for significant ocular surface disease

  3. Fluorescein tear break-up time [ Time Frame: 90 Days ]
    Clinical measure of tear film stability

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age > 18 years
  • Typical symptoms of dry eye (photophobia, burning, foreign body sensation, blurred vision improved with blinking)
  • OSDI score > 12
  • Schirmer Test with Anesthesia < 8 mm/5 minutes
  • Fluorescein tear break-up time < 8 seconds
  • No current use of dry eye treatment (except artificial lubrication)

Exclusion Criteria:

  • Infectious keratoconjunctivitis or inflammatory disease unrelated to dry eye or topical glaucoma medication use
  • Patients with severe tear deficiency (defined as Schirmer tes <5 mm/5 min)
  • Concomitant ocular pathology
  • History of ocular surgery
  • Eyelid or eyelash abnormalities
  • Alteration of the nasolacrimal apparatus
  • Treatment with drugs affecting tearing
  • Treatment with vitamin supplements
  • Concomitant ocular therapies
  • Topical ophthalmic steroids taken during the 4 weeks before the study
  • Pregnant/breast-feeding women
  • Women who may be pregnant at the baseline visit or may become pregnant during the 90 days of therapy
  • Diabetes
  • History of fish and/or shellfish allergy or hypersensitivity

Information from the National Library of Medicine

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 identifier (NCT number): NCT01630551

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United States, Illinois
Glaucoma Service, Department of Ophthalmology and Visual Science
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
American Glaucoma Society
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Principal Investigator: Ahmad A Aref, MD University of Illinois at Chicago College of Medicine
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Responsible Party: Ahmad A. Aref, MD, Assistant Professor, University of Illinois at Chicago Identifier: NCT01630551    
Other Study ID Numbers: 2011-1136
First Posted: June 28, 2012    Key Record Dates
Last Update Posted: February 28, 2017
Last Verified: February 2017
Keywords provided by Ahmad A. Aref, MD, University of Illinois at Chicago:
dry eyes
ocular surface disease