NCT01630551

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2012

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 28, 2012

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

February 28, 2017

Status Verified

February 1, 2017

Enrollment Period

4.8 years

First QC Date

May 31, 2012

Last Update Submit

February 24, 2017

Conditions

Ocular Surface Disease

Keywords

tearsdry eyesocular surface disease

Outcome Measures

Primary Outcomes (1)

  • Ocular Surface Disease Index Score

    Ocular surface disease validated questionnaire regarding ocular symptoms

    90 Days

Secondary Outcomes (3)

  • Schirmer test score

    90 days

  • Lissamine Green Staining Score

    90 Days

  • Fluorescein tear break-up time

    90 Days

Study Arms (2)

Fishoil nutritional supplement

ACTIVE COMPARATOR

90 day supply of daily oral administration of a fish oil nutritional supplement (TheraTears Nutrition; Advanced Vision Research, Woburn, MA)

Dietary Supplement: Fishoil supplement

Olive oil capsules

PLACEBO COMPARATOR

90 day supply of a daily dose of placebo olive oil capsules

Dietary Supplement: Olive Oil

Interventions

Fishoil supplementDIETARY_SUPPLEMENT

1 capsule per day

Fishoil nutritional supplement
Olive OilDIETARY_SUPPLEMENT

1 capsule per day

Olive oil capsules

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glaucoma Service, Department of Ophthalmology and Visual Science

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

LacerationsDry Eye Syndromes

Interventions

Olive Oil

Condition Hierarchy (Ancestors)

Wounds and InjuriesLacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Ahmad A Aref, MD

    University of Illinois at Chicago College of Medicine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Omega 3 fatty acid
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 31, 2012

First Posted

June 28, 2012

Study Start

April 1, 2012

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

February 28, 2017

Record last verified: 2017-02

Locations

US(1)