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Omega 3 and Ocular Surface Disease

This study is currently recruiting participants.
Verified June 2012 by University of Illinois
Sponsor:
Collaborator:
American Glaucoma Society
Information provided by (Responsible Party):
Ahmad A. Aref, MD, University of Illinois
ClinicalTrials.gov Identifier:
NCT01630551
First received: May 31, 2012
Last updated: June 26, 2012
Last verified: June 2012
History of Changes
  Purpose

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 Intervention Phase
Ocular Surface Disease
 Dietary Supplement: Fishoil supplement
Dietary Supplement: Olive Oil
 Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Illinois:

Primary Outcome Measures:
  • Ocular Surface Disease Index Score [ Time Frame: 90 Days ] [ Designated as safety issue: No ]
    Ocular surface disease validated questionnaire regarding ocular symptoms


Secondary Outcome Measures:
  • Schirmer test score [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    Scoring of tear production over 5 minutes

  • Lissamine Green Staining Score [ Time Frame: 90 Days ] [ Designated as safety issue: No ]
    Ocular staining pattern for significant ocular surface disease

  • Fluorescein tear break-up time [ Time Frame: 90 Days ] [ Designated as safety issue: No ]
    Clinical measure of tear film stability


Estimated Enrollment: 50
Study Start Date: April 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01630551

Locations
United States, Illinois
Glaucoma Service, Department of Ophthalmology and Visual Science Recruiting
Chicago, Illinois, United States, 60612
Contact: Ahmad Aref, MD     312-996-7030        
Contact: Anna Castro-Malek, BA CCRC     312-996-4747        
Principal Investigator: Ahmad Aref, MD            
Sub-Investigator: Thasarat Vajaranant, MD            
Sponsors and Collaborators
University of Illinois
American Glaucoma Society
  More Information

No publications provided

Responsible Party: Ahmad A. Aref, MD, Assistant Professor, University of Illinois
ClinicalTrials.gov Identifier: NCT01630551     History of Changes
Other Study ID Numbers: 2011-1136
Study First Received: May 31, 2012
Last Updated: June 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Illinois:
tears
dry eyes
ocular surface disease

ClinicalTrials.gov processed this record on June 18, 2013