Back to resultsEffect of Re-esterified Triglyceride (rTG) Form Omega-3 Supplements on Dry Eye Following Cataract Surgery
Primary Purpose
Dry Eye
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Omega 3
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Omega
Arm Description
Omega-3 re-esterified triglyceride form
Outcomes
Primary Outcome Measures
Dry eye symptom
Improvement of symptom
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04411615
Brief Title
Effect of Re-esterified Triglyceride (rTG) Form Omega-3 Supplements on Dry Eye Following Cataract Surgery
Official Title
Effect of Re-esterified Triglyceride (rTG) Form Omega-3 Supplements on Dry Eye Following Cataract Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2020 (Anticipated)
Primary Completion Date
August 1, 2020 (Anticipated)
Study Completion Date
February 28, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Omega
Arm Type
Experimental
Arm Description
Omega-3 re-esterified triglyceride form
Intervention Type
Drug
Intervention Name(s)
Omega 3
Intervention Description
rTG form Omega-3
Primary Outcome Measure Information:
Title
Dry eye symptom
Description
Improvement of symptom
Time Frame
1 month
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tae-Young Chung
Phone
82-2-3410-3563
Email
tychung@skku.edu
12. IPD Sharing Statement
Citations:
PubMed Identifier
32917627
Citation
Park J, Yoo YS, Shin E, Han G, Shin K, Lim DH, Chung TY. Effects of the re-esterified triglyceride (rTG) form of omega-3 supplements on dry eye following cataract surgery. Br J Ophthalmol. 2021 Nov;105(11):1504-1509. doi: 10.1136/bjophthalmol-2020-317164. Epub 2020 Sep 11.
Results Reference
derived
Learn more about this trial
Effect of Re-esterified Triglyceride (rTG) Form Omega-3 Supplements on Dry Eye Following Cataract Surgery
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