Dry EyeNCT04411615
Effect of Re-esterified Triglyceride (rTG) Form Omega-3 Supplements on Dry Eye Following Cataract Surgery
A study testing Omega 3 in people with Dry Eye, run by Samsung Medical Center.
Trial 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 Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- Omega 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2020to 28 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Non complicated cataract surgery
- Patients with dry eye symptom
Who cannot join
- Using steroid eyedops,
- Using antibiotics eyedrops
- Surgery other than Cataract surgery
- Contact lens wearer
- Other systemic disease
Trial locations and contacts
No sites are listed yet.
About this study
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
- Conditions
- Dry Eye
- Being tested
- Omega 3
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega 3Drug
rTG form Omega-3
| Study group | Role | What they receive |
|---|---|---|
| Omega | Experimental | Omega-3 re-esterified triglyceride form Receives: Drug: Omega 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dry eye symptom
Improvement of symptom
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start1 Jul 2020 (estimated)
- Primary completion1 Aug 2020 (estimated)
- Study completion28 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, tae-young chung, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04411615
- Sponsor's protocol ID
- 2020-01-150
- Status last verified
- May 2020
- First submitted
- 28 May 2020
- Last updated
- 2 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32917627
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Re-esterified Triglyceride (rTG) Form Omega-3 Supplements on Dry Eye Following Cataract Surgery
- ClinicalTrials.gov ID
- NCT04411615
- Acronym / sponsor ID
- 2020-01-150
- Conditions
- Dry Eye
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 1 Aug 2020 (estimated)
- Study completion
- 28 Feb 2021 (estimated)
- First posted
- 2 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Omega | Experimental | Drug: Omega 3Omega-3 re-esterified triglyceride form |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Non complicated cataract surgery
- Patients with dry eye symptom
Key exclusion criteria (5 listed)
- Using steroid eyedops,
- Using antibiotics eyedrops
- Surgery other than Cataract surgery
- Contact lens wearer
- Other systemic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega 3rTG form Omega-3 | Drug | Omega |
Primary outcome
Dry eye symptom
Time frame: 1 month
Improvement of symptom
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
- Derived from this study: PubMed 32917627Park 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Omega 3 in people with Dry Eye, run by Samsung Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tae-Young Chung (82-2-3410-3563, tychung@skku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dry eye symptom (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04411615, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2020.