NCT04411615

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 2, 2020

Completed
29 days until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
Last Updated

June 2, 2020

Status Verified

May 1, 2020

Enrollment Period

1 month

First QC Date

May 28, 2020

Last Update Submit

June 1, 2020

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

  • Dry eye symptom

    Improvement of symptom

    1 month

Study Arms (1)

Omega

EXPERIMENTAL

Omega-3 re-esterified triglyceride form

Drug: Omega 3

Interventions

Omega 3DRUG

rTG form Omega-3

Omega

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Non complicated cataract surgery
  • Patients with dry eye symptom

You may not qualify if:

  • Using steroid eyedops,
  • Using antibiotics eyedrops
  • Surgery other than Cataract surgery
  • Contact lens wearer
  • Other systemic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 32917627DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Central Study Contacts

Tae-Young Chung

CONTACT

82-2-3410-3563tychung@skku.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D. PhD

Study Record Dates

First Submitted

May 28, 2020

First Posted

June 2, 2020

Study Start

July 1, 2020

Primary Completion

August 1, 2020

Study Completion

February 28, 2021

Last Updated

June 2, 2020

Record last verified: 2020-05