NCT01107964

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

April 20, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 21, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2015

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

December 22, 2017

Completed
Last Updated

December 22, 2017

Status Verified

November 1, 2017

Enrollment Period

4.1 years

First QC Date

April 20, 2010

Results QC Date

October 17, 2017

Last Update Submit

November 29, 2017

Conditions

Dry Eye Syndrome

Keywords

Dry Eye SyndromeRecent Diagnosis of Dry Eye Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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)

    Baseline and Day 45

Secondary Outcomes (3)

  • Change From Baseline of Schirmer-1 Test Value at Day 45

    Baseline and Day 45

  • Change From Baseline of Lissamine Green Staining Score at Day 45

    Baseline and Day 45

  • Change From Baseline of Fluorescein Tear Break-Up Time (Seconds) at Day 45

    Baseline and Day 45

Study Arms (2)

Omega-3-acid ethyl esters

ACTIVE COMPARATOR
Drug: Oral Omega-3-acid ethyl esters

Corn oil capsule

PLACEBO COMPARATOR
Drug: Placebo corn oil capsule

Interventions

Oral Omega-3-acid ethyl estersDRUG

1 gram capsule by mouth four times daily for 45 days

Omega-3-acid ethyl esters
Placebo corn oil capsuleDRUG

1 gram by mouth 4 times daily for 45 days

Corn oil capsule

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)
  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Hershey Eye Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Omacor

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Results Point of Contact

Title
Dr. David Liang
Organization
Milton S. Hershey Medical Center
dliang12@yahoo.com
717-497-9469

Study Officials

  • David Liang, MD

    Milton S. Hershey Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

April 20, 2010

First Posted

April 21, 2010

Study Start

July 1, 2010

Primary Completion

August 1, 2014

Study Completion

June 15, 2015

Last Updated

December 22, 2017

Results First Posted

December 22, 2017

Record last verified: 2017-11

Locations

US(1)