Oral Omega-3 Fatty Acids in the Treatment of Dry Eye Syndrome
This study is currently recruiting participants.
Verified May 2012 by Penn State University
Sponsor:
Penn State University
Collaborators:
The American Society of Cataract and Refractive Surgery Foundation
GlaxoSmithKline
Information provided by (Responsible Party):
Ahmad A. Aref, Penn State University
ClinicalTrials.gov Identifier:
NCT01107964
First received: April 20, 2010
Last updated: May 14, 2012
Last verified: May 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Dry Eye Syndrome |
Drug: Oral Omega-3-acid ethyl esters Drug: Placebo corn oil capsule |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Oral Omega-3 Fatty Acids in the Treatment of Dry Eye Syndrome |
Resource links provided by NLM:
Further study details as provided by Penn State University:
Primary Outcome Measures:
- Ocular Surface Disease Index Score as a measure of subjective symptoms of dry eye [ Time Frame: 45 days post-intervention ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Schirmer-1 test value (mm/5 min) as a measure of tear production [ Time Frame: 45 days post-intervention ] [ Designated as safety issue: No ]
- Lissamine Green staining score as a measure of ocular surface irregularity secondary to dry eye [ Time Frame: 45 days post-intervention ] [ Designated as safety issue: No ]
- Fluorescein tear break-up time (seconds) as a measure of tear film stability [ Time Frame: 45 days post-intervention ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | July 2010 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Omega-3-acid ethyl esters |
Drug: Oral Omega-3-acid ethyl esters
1 gram capsule by mouth four times daily for 45 days
|
| Placebo Comparator: Corn oil capsule |
Drug: Placebo corn oil capsule
1 gram by mouth 4 times daily for 45 days
|
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)
- 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
- 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
- History of liver disease
- Diabetes
- 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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01107964
Contacts
| Contact: Ahmad A Aref, MD | (717) 531-8783 | ahmadaref@gmail.com |
Locations
| United States, Pennsylvania | |
| Penn State Hershey Eye Center | Recruiting |
| Hershey, Pennsylvania, United States, 17033 | |
| Contact: Ahmad A Aref, MD 717-531-8783 ahmadaref@gmail.com | |
| Principal Investigator: Ahmad A Aref, MD | |
| Principal Investigator: David Liang, MD | |
| Sub-Investigator: Jeffrey M Sundstrom, MD, PhD | |
| Sub-Investigator: Allen R Kunselman, MA | |
Sponsors and Collaborators
Penn State University
The American Society of Cataract and Refractive Surgery Foundation
GlaxoSmithKline
More Information
No publications provided
| Responsible Party: | Ahmad A. Aref, Physician, Penn State University |
| ClinicalTrials.gov Identifier: | NCT01107964 History of Changes |
| Other Study ID Numbers: | 33794 |
| Study First Received: | April 20, 2010 |
| Last Updated: | May 14, 2012 |
| Health Authority: | United States: Institutional Review Board United States: Food and Drug Administration |
Keywords provided by Penn State University:
|
Dry Eye Syndrome Recent Diagnosis of Dry Eye Syndrome |
Additional relevant MeSH terms:
|
Dry Eye Syndromes Keratoconjunctivitis Sicca Lacrimal Apparatus Diseases Eye Diseases Keratoconjunctivitis |
Conjunctivitis Conjunctival Diseases Keratitis Corneal Diseases |
ClinicalTrials.gov processed this record on May 16, 2013