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Dry Eye Assessment and Management: Feasibility Study

NCT01102257 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2012-08-23

Study results available
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Summary

The purpose of this study is to test a protocol investigating the efficacy of omega-3 fatty acids in treating dry eye disease. The study is termed "feasibility" because its purpose is to demonstrate an ability to execute the proposed protocol with compliance at two sites rather than generate statistically relevant data concerning the safety and efficacy of the supplement in patients with dry eye disease.

Conditions

  • Dry Eye Syndromes
  • Keratoconjunctivitis Sicca

Interventions

DRUG

Omega-3 EFA Supplement

The total daily dose from the 5 capsules in treatment group will be 3.0 grams of omega-3 EFAs comprised of: 2000 mg EPA 1000 mg DHA

DRUG

Olive Oil

Placebo group will take 5 capsules a day containing 3.0 grams of olive oil

Sponsors & Collaborators

  • National Eye Institute (NEI)

    collaborator NIH

  • Asbell, Penny, M.D.

    lead INDIV

Principal Investigators

  • Penny Asbell, • MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-07-31
Completion
2011-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01102257 on ClinicalTrials.gov