- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04411615
Effect of Re-esterified Triglyceride (rTG) Form Omega-3 Supplements on Dry Eye Following Cataract Surgery
June 1, 2020 updated by: tae-young chung, Samsung Medical Center
To evaluate the clinical outcomes of the systemic re-esterified triglyceride (rTG) form of omega-3 fatty acids in patients with dry eye symptoms after cataract surgery
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Tae-Young Chung
- Phone Number: 82-2-3410-3563
- Email: tychung@skku.edu
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Non complicated cataract surgery
- Patients with dry eye symptom
Exclusion Criteria:
- Using steroid eyedops,
- Using antibiotics eyedrops
- Surgery other than Cataract surgery
- Contact lens wearer
- Other systemic disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Omega
Omega-3 re-esterified triglyceride form
|
rTG form Omega-3
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dry eye symptom
Time Frame: 1 month
|
Improvement of symptom
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
July 1, 2020
Primary Completion (ANTICIPATED)
August 1, 2020
Study Completion (ANTICIPATED)
February 28, 2021
Study Registration Dates
First Submitted
May 28, 2020
First Submitted That Met QC Criteria
June 1, 2020
First Posted (ACTUAL)
June 2, 2020
Study Record Updates
Last Update Posted (ACTUAL)
June 2, 2020
Last Update Submitted That Met QC Criteria
June 1, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-01-150
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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