CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 23 enrolled
Drug / intervention
Omega-3 EFA Supplement +1 moredrug
Likely dose
Omega-3 EFA Supplement 2000 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01102257
NCT01102257Phase 3Completed
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Clinical Trial of Essential Fatty Acids for Dry Eye Disease: Feasibility Study

Asbell, Penny, M.D.·interventional·Posted Apr 13, 2010·Updated Aug 23, 2012

In Brief

A Phase 3 clinical trial evaluating Omega-3 EFA Supplement and Olive Oil for Dry Eye Syndromes and Keratoconjunctivitis Sicca. Completed, enrolled 23 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye Syndromes, Keratoconjunctivitis Sicca
CountriesUnited States
CollaboratorsNational Eye Institute (NEI)

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 13, 2010
Enrollment StartJan 1, 2010
Primary CompletionJul 1, 2010
Study CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 16.2 years ago

Interventions

Omega-3 EFA Supplementdrug

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

Olive Oildrug

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