N/A
Completed N=27
Oral Omega-3 Fatty Acids in the Treatment of Dry Eye Syndrome
Source: ClinicalTrials.gov NCT01107964 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcomePrimary: Change From Baseline of the Ocular Surface Disease Index Score at Day 45 — -28.4; -5.8 units on a scale — p=0.61
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline of the Ocular Surface Disease Index Score at Day 45 |
-28.4; -5.8 | 0.61 |
| SECONDARY Change From Baseline of Schirmer-1 Test Value at Day 45 |
-2.5; 1.0 | 0.57 |
| SECONDARY Change From Baseline of Lissamine Green Staining Score at Day 45 |
1.0; -1.0 | 0.44 |
| SECONDARY Change From Baseline of Fluorescein Tear Break-Up Time (Seconds) at Day 45 |
1.7; 0.3 | 0.48 |
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)
Data sourced from ClinicalTrials.gov (NCT01107964). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.