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NCT01213342 · ClinicalTrials.gov registry record · NA
Omega-3 Fatty Acid Supplements and Dry Eye
A NA study, sponsored by Ohio State University.
- Terminated
- Registry status
- NA
- Development phase
- 35
- Enrollment target
NCT01213342: Clinical Trial NA study, sponsored by Ohio State University.
NCT01213342 is a NA study that was terminated before completion, run by Ohio State University. The registered enrollment target is 35 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01213342, a NA study, was terminated before completion, sponsored by Ohio State University.
- TERMINATED
- Registry status
- NA
- Development phase
- 35 participants
- Enrollment target
Study Summary
Omega-3 fatty acids have been associated with a decline in inflammation. As dry eye disease is associated with inflammation of the ocular surface (DEWS report, Ocular Surface, 2007), the investigators hypothesize that the omega-3 fatty acid supplements used in this study will help to improve dry eye signs, such as eye surface irritation (staining) and tear film osmolarity, which is an overall measure of tear film stability and dry eye status. Further, the investigators hypothesize that dry eye symptoms, the end result of dry eye disease, such as discomfort and burning, will also improve with supplementation.
Primary Outcome
Based on previous unpublished work by our group (and others), it is suggestive that a 10 unit change in OSDI score may be clinically meaningful. There currently is no accepted survey instrument to monitor change in DED clinical trials, although the OSDI has wide acceptance clinically. This study will help define what unit of change may be clinically and statistically acceptable for future trials.
Interventions
- DIETARY_SUPPLEMENT Omega-3 Fatty Acid
- DIETARY_SUPPLEMENT Soybean Soft Gels
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2010-05 |
| Est. Completion | 2011-07 |
| Phase | NA |
Why NCT01213342 stopped before completion
NCT01213342 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Omega-3 Fatty Acid is the first listed.
NCT01213342 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01213342 about?
NCT01213342 is a clinical study titled "Omega-3 Fatty Acid Supplements and Dry Eye". Omega-3 fatty acids have been associated with a decline in inflammation. As dry eye disease is associated with inflammation of the ocular surface (DEWS report, Ocular Surface, 2007), the investigators hypothesize that the omega-3 fatty acid supplements used in this study will help to improve dry eye...
What is the current status of trial NCT01213342?
This trial is currently terminated. It is a NA study. The enrollment target is 35 participants. The study started on 2010-05. Estimated completion is 2011-07.
What interventions are being tested in trial NCT01213342?
The interventions under investigation include: Omega-3 Fatty Acid (DIETARY_SUPPLEMENT), Soybean Soft Gels (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01213342?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01213342's enrollment target sits among peer trials
35 1564th of 2000 higher than 431 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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