Omega 3 Supplementation and Ocular Surface Disease in Glaucoma

Omega-3 Fatty Acid Nutritional Supplementation in the Treatment of Ocular Surface Disease Associated With Intraocular Pressure-Lowering Medications

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

Study Overview

• Status: Withdrawn
• Conditions: Ocular Surface Disease
• Intervention / Treatment: Dietary supplement: Fishoil supplement; Dietary supplement: Olive Oil

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Glaucoma Service, Department of Ophthalmology and Visual Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular Surface Disease Index Score	Ocular surface disease validated questionnaire regarding ocular symptoms	90 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Schirmer test score	Scoring of tear production over 5 minutes	90 days
Lissamine Green Staining Score	Ocular staining pattern for significant ocular surface disease	90 Days
Fluorescein tear break-up time	Clinical measure of tear film stability	90 Days

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Collaborators: American Glaucoma Society
• Investigators: Principal Investigator: Ahmad A Aref, MD, University of Illinois at Chicago College of Medicine

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: May 31, 2012
• First Submitted That Met QC Criteria: June 26, 2012
• First Posted (Estimate): June 28, 2012

Study Record Updates

• Last Update Posted (Actual): February 28, 2017
• Last Update Submitted That Met QC Criteria: February 24, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: tears; dry eyes; ocular surface disease
• Other Study ID Numbers: 2011-1136