search
Back to results

Oral Omega-3 Fatty Acids in the Treatment of Dry Eye Syndrome

Primary Purpose

Dry Eye Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oral Omega-3-acid ethyl esters
Placebo corn oil capsule
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndrome focused on measuring Dry Eye Syndrome, Recent Diagnosis of Dry Eye Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Infectious keratoconjunctivitis or inflammatory disease unrelated to dry eye
  • Eyelid or eyelash abnormalities
  • Alteration of the nasolacrimal apparatus
  • Treatment with drugs affecting tearing
  • Concomitant ocular therapies
  • Topical ophthalmic steroids taken during the 4 weeks before the study
  • Pregnant/breast-feeding women
  • History of liver disease
  • History of fish and/or shellfish allergy or hypersensitivity
  • History of corn allergy or hypersensitivity
  • Treatment with systemic anticoagulation therapy
  • Patients with bleeding disorders or those receiving anticoagulation (e.g., warfarin, enoxaparin, dipyridamole, clopidogrel)

Sites / Locations

  • Penn State Hershey Eye Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Omega-3-acid ethyl esters

Corn oil capsule

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline of the Ocular Surface Disease Index Score at Day 45
The Ocular Surface Disease Index Score is a validated, scored questionnaire that measures subjective symptoms of dry eye. Possible scores range from 0 (no symptoms of dry eye) to 100 (severest symptoms of dry eye). Change = (Day 45 score - Baseline score)

Secondary Outcome Measures

Change From Baseline of Schirmer-1 Test Value at Day 45
Schirmer-1 Test Value is a measurement of tear production. The amount of tears are measured in total millimeters after 5 minutes has elapsed. Low levels of tear production are associated with dry eye. Change = (Day 45 value - Baseline value).
Change From Baseline of Lissamine Green Staining Score at Day 45
Lissamine Green Staining Score is a measure of ocular surface irregularity secondary to dry eye. Possible scores range from 0 (no ocular surface irregularity secondary to dry eye) to 9 (severe ocular surface irregularity secondary to dry eye). Change = (Day 45 score - Baseline score)
Change From Baseline of Fluorescein Tear Break-Up Time (Seconds) at Day 45
Fluorescein Tear Break-Up Time is a measurement in seconds of tear film stability. The shorter the Fluorescein Tear Break-Up Time, the lower the tear film stability. Lower tear film stability is associated with dry eye. Change = (Day 45 value - Baseline value).

Full Information

First Posted
April 20, 2010
Last Updated
November 29, 2017
Sponsor
Milton S. Hershey Medical Center
Collaborators
The American Society of Cataract and Refractive Surgery Foundation, GlaxoSmithKline
search

1. Study Identification

Unique Protocol Identification Number
NCT01107964
Brief Title
Oral Omega-3 Fatty Acids in the Treatment of Dry Eye Syndrome
Official Title
Oral Omega-3 Fatty Acids in the Treatment of Dry Eye Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
June 15, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
Collaborators
The American Society of Cataract and Refractive Surgery Foundation, GlaxoSmithKline

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators hypothesize that oral omega-3-acid ethyl esters (Lovaza, GlaxoSmithKline, Research Triangle Park, NC) will decrease dry-eye related symptoms as well as clinical markers associated with dry eye disease (Schirmer-1 test values, positive vital staining with lissamine green, and fluorescein tear break-up time) when compared to administration of placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndrome
Keywords
Dry Eye Syndrome, Recent Diagnosis of Dry Eye Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Omega-3-acid ethyl esters
Arm Type
Active Comparator
Arm Title
Corn oil capsule
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Oral Omega-3-acid ethyl esters
Intervention Description
1 gram capsule by mouth four times daily for 45 days
Intervention Type
Drug
Intervention Name(s)
Placebo corn oil capsule
Intervention Description
1 gram by mouth 4 times daily for 45 days
Primary Outcome Measure Information:
Title
Change From Baseline of the Ocular Surface Disease Index Score at Day 45
Description
The Ocular Surface Disease Index Score is a validated, scored questionnaire that measures subjective symptoms of dry eye. Possible scores range from 0 (no symptoms of dry eye) to 100 (severest symptoms of dry eye). Change = (Day 45 score - Baseline score)
Time Frame
Baseline and Day 45
Secondary Outcome Measure Information:
Title
Change From Baseline of Schirmer-1 Test Value at Day 45
Description
Schirmer-1 Test Value is a measurement of tear production. The amount of tears are measured in total millimeters after 5 minutes has elapsed. Low levels of tear production are associated with dry eye. Change = (Day 45 value - Baseline value).
Time Frame
Baseline and Day 45
Title
Change From Baseline of Lissamine Green Staining Score at Day 45
Description
Lissamine Green Staining Score is a measure of ocular surface irregularity secondary to dry eye. Possible scores range from 0 (no ocular surface irregularity secondary to dry eye) to 9 (severe ocular surface irregularity secondary to dry eye). Change = (Day 45 score - Baseline score)
Time Frame
Baseline and Day 45
Title
Change From Baseline of Fluorescein Tear Break-Up Time (Seconds) at Day 45
Description
Fluorescein Tear Break-Up Time is a measurement in seconds of tear film stability. The shorter the Fluorescein Tear Break-Up Time, the lower the tear film stability. Lower tear film stability is associated with dry eye. Change = (Day 45 value - Baseline value).
Time Frame
Baseline and Day 45

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 18 years Typical symptoms of dry eye (photophobia, burning, foreign body sensation, blurred vision improved with blinking) Schirmer Test < 8 mm/5 minutes Fluorescein tear break-up time < 8 seconds No current use of dry eye treatment (except artificial lubrication) Signature on consent form Exclusion Criteria: Infectious keratoconjunctivitis or inflammatory disease unrelated to dry eye Eyelid or eyelash abnormalities Alteration of the nasolacrimal apparatus Treatment with drugs affecting tearing Concomitant ocular therapies Topical ophthalmic steroids taken during the 4 weeks before the study Pregnant/breast-feeding women History of liver disease History of fish and/or shellfish allergy or hypersensitivity History of corn allergy or hypersensitivity Treatment with systemic anticoagulation therapy Patients with bleeding disorders or those receiving anticoagulation (e.g., warfarin, enoxaparin, dipyridamole, clopidogrel)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Liang, MD
Organizational Affiliation
Milton S. Hershey Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State Hershey Eye Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Oral Omega-3 Fatty Acids in the Treatment of Dry Eye Syndrome

We'll reach out to this number within 24 hrs