UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059836 |
|---|---|
| Receipt number | R000068428 |
| Scientific Title | Omega-3 fatty acids and tear cytokine modulation in dry eye patients with low omega-3 index. Have the beneficiaries been pinpointed? |
| Date of disclosure of the study information | 2025/11/20 |
| Last modified on | 2025/11/20 16:58:02 |
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Basic information
Public title
Are dry eye patients with low omega-3 index the beneficiaries of omega-3 fatty acids supplements?
Acronym
Are dry eye patients with low omega-3 index the beneficiaries of omega-3 fatty acids supplements?
Scientific Title
Omega-3 fatty acids and tear cytokine modulation in dry eye patients with low omega-3 index. Have the beneficiaries been pinpointed?
Scientific Title:Acronym
Omega-3 fatty acids and tear cytokine modulation in dry eye patients with low omega-3 index. Have the beneficiaries been pinpointed?
Region
| Asia(except Japan) |
Condition
Condition
Dry eye
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Does omega 3 fatty acids benefit dry eye patients with omega 3 index below 4%?
Basic objectives2
Others
Basic objectives -Others
Tear cytokine modulation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cytokines
Tears
Conjunctiva
Computer users
Key secondary outcomes
Schirmer
TBUT
Goblet cells
Symptoms
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Four capsules each containing 325 mg of EPA and 175 mg of DHA, totalling 1300 mg of EPA and 700 mg of DHA per day for 6 months.
Interventions/Control_2
Olive oil capsules comprising 70% oleic acid, 18% linoleic acid, and 12% palmitic acid twice daily for 6 months
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Symptomatic dry eye patients with omega-3 index less than 4%
Key exclusion criteria
Current ocular infection
recent refractive surgery
allergic conjunctivitis
contact lens use
herpetic eye disease
diabetes
liver diseases
inability to swallow soft gel capsules,
aspirin or anti-coagulant therapy
allergy to fluorescein
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Rahul |
| Middle name | |
| Last name | Bhargava |
Organization
GS Medical College & Hospital
Division name
Uttar pradesh
Zip code
245304
Address
Village Piplibandarpur, Pilkhuwa, Distt. Hapur, UP, India
TEL
+919999055223
rahulbhargav@ymail.com
Public contact
Name of contact person
| 1st name | Prachi |
| Middle name | |
| Last name | Kumar |
Organization
Yashodha Medicity
Division name
Ghaziabad
Zip code
201014
Address
Niti Khand 3, Shakti Khand 2, Indirapuram, Ghaziabad, Uttar Pradesh
TEL
+918076020248
Homepage URL
kumarprachi@yahoo.co.in
Sponsor or person
Institute
IGMC Shimla, HP, India
Institute
Department
Personal name
Vinod Sharma
Funding Source
Organization
Laser Eye Clinic, Noida, UP, India
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
India
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
GS Medical College
Address
Village Piplibandarpur, Pilkhuwa
Tel
917055514537
hod.ophthal@gsmedical college.in
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2025 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 20 | Day |
Last modified on
| 2025 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068428
