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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.
 
ClinicalTrials.gov Identifier: NCT01630551
Recruitment Status : Withdrawn (No participants enrolled)
First Posted : June 28, 2012
Last Update Posted : February 28, 2017
Sponsor:
Collaborator:
American Glaucoma Society
Information provided by (Responsible Party):
Ahmad A. Aref, MD, University of Illinois at Chicago

Tracking Information
First Submitted Date  ICMJE May 31, 2012
First Posted Date  ICMJE June 28, 2012
Last Update Posted Date February 28, 2017
Study Start Date  ICMJE April 2012
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2012)
Ocular Surface Disease Index Score [ Time Frame: 90 Days ]
Ocular surface disease validated questionnaire regarding ocular symptoms
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2012)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Omega 3 Supplementation and Ocular Surface Disease in Glaucoma
Official Title  ICMJE Omega-3 Fatty Acid Nutritional Supplementation in the Treatment of Ocular Surface Disease Associated With Intraocular Pressure-Lowering Medications
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

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Omega 3 fatty acid
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Ocular Surface Disease
Intervention  ICMJE
  • Dietary Supplement: Fishoil supplement
    1 capsule per day
  • Dietary Supplement: Olive Oil
    1 capsule per day
Study Arms  ICMJE
  • 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)
    Intervention: Dietary Supplement: Fishoil supplement
  • Placebo Comparator: Olive oil capsules
    90 day supply of a daily dose of placebo olive oil capsules
    Intervention: Dietary Supplement: Olive Oil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: February 24, 2017)
0
Original Estimated Enrollment  ICMJE
 (submitted: June 26, 2012)
50
Actual Study Completion Date  ICMJE February 2017
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01630551
Other Study ID Numbers  ICMJE 2011-1136
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ahmad A. Aref, MD, University of Illinois at Chicago
Study Sponsor  ICMJE University of Illinois at Chicago
Collaborators  ICMJE American Glaucoma Society
Investigators  ICMJE
Principal Investigator: Ahmad A Aref, MD University of Illinois at Chicago College of Medicine
PRS Account University of Illinois at Chicago
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP