Effect of Re-esterified Triglyceride (rTG) Form Omega-3 S... | NCT04411615

Studies
Effect of Re-esterified Triglyceride (rTG) Form Omega-3 Supplements on Dry Eye Following Cataract Surgery

NCT04411615

Sponsor

Samsung Medical Center

Status

Unknown status

Last Update Posted

Jun 2, 2020Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Dry Eye

Interventions

Omega 3

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2020Estimated

Primary Completion Date

Aug 1, 2020Estimated

Completion Date

Feb 28, 2021Estimated

First Submitted Date

May 28, 2020

First Submission Date that Met QC Criteria

Jun 1, 2020

First Posted Date

Jun 2, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 1, 2020

Last Update Posted Date

Jun 2, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Omega	Experimental	Omega-3 re-esterified triglyceride form	Drug: Omega 3

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Omega 3	Drug	rTG form Omega-3	Omega

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dry eye symptom	Improvement of symptom	1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tae-Young Chung	Contact	82-2-3410-3563		tychung@skku.edu

Overall Officials

Not provided

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32917627	Derived	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.

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases

ID	Term
D015525	Fatty Acids, Omega-3
D004042	Dietary Fats, Unsaturated
D004041	Dietary Fats
D005223	Fats