UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059789 |
|---|---|
| Receipt number | R000068363 |
| Scientific Title | Efficacy of Omega-3 Supplementation in Patients with Dry Eyes Disease: An Interventional Study |
| Date of disclosure of the study information | 2025/11/15 |
| Last modified on | 2025/11/15 14:00:53 |
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Basic information
Public title
Efficacy of Omega-3 Supplementation in Patients with Dry Eyes Disease: An Interventional Study
Acronym
Efficacy of Omega-3 Supplementation in Patients with Dry Eyes Disease: An Interventional Study
Scientific Title
Efficacy of Omega-3 Supplementation in Patients with Dry Eyes Disease: An Interventional Study
Scientific Title:Acronym
Efficacy of Omega-3 Supplementation in Patients with Dry Eyes Disease: An Interventional Study
Region
| Asia(except Japan) |
Condition
Condition
Dry eyes disease
Classification by specialty
| Ophthalmology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether omega-3 supplementation is effective in improving the signs and symptoms of dry eye disease compared to standard therapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in the tear film break-up time (TBUT) from baseline to 12 weeks after omega-3 supplementation
Key secondary outcomes
Change in the Ocular Surface Disease Index (OSDI) score from baseline to 12 weeks after omega-3 supplementation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Food |
Interventions/Control_1
Intervention Group (Optimax O3 - Omega-3 Supplementation): Participants in the intervention group will receive Optimax O3 at a dose of 2 capsules once daily for 12 weeks. Each capsule contains EPA 180 mg, DHA 120 mg, Lutein 10 mg, and Lycopene 2 mg. Participants record daily intake in a diary and remaining capsules returned at each follow-up visit for compliance verification. The supplementation is given in addition to standard therapy
Interventions/Control_2
Control Group: Control group will receive standard therapy only, consisting of artificial tears or hyaluronic acid or corticosteroid eye drops according to routine clinical practice. No Omega-3 supplementation will be given in the control group.
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
| 17 | years-old | < |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Age 17-69 years old
2. Diagnosed with dry eyes disease
3. Willing to participate and provide informed consent
Key exclusion criteria
1. Declines to participate in the study
2. Patient with type 2 diabetes mellitus
3. History of ocular surgery (post-operative patients within the past 12 months)
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Cisca |
| Middle name | |
| Last name | Kuswidyati |
Organization
Atmajaya Hospital, Jakarta, Indonesia
Division name
Department of Ophthalmology
Zip code
14440
Address
No. 2, Pluit Raya Street, RT 21/RW 8, Penjaringan District, North Jakarta, Indonesia
TEL
+62811922143
cisca.kuswidyati@gmail.com
Public contact
Name of contact person
| 1st name | Luciana |
| Middle name | |
| Last name | Luciana |
Organization
School of Medicine and Health Sciences, Atma Jaya Catholic University of Indonesia
Division name
Department of Ophthalmology
Zip code
14440
Address
No. 2, Pluit Raya Street, RT 21/RW 8, Penjaringan District, North Jakarta, Indonesia
TEL
+6281369726379
Homepage URL
L.haryady@hotmail.com
Sponsor or person
Institute
Atma Jaya Catholic University of Indonesia
Institute
Department
Personal name
Funding Source
Organization
University research grant
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Indonesia
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Komisi Etika Penelitian Fakultas Kedokteran dan Ilmu Kesehatan, Universitas Katolik Indonesia Atma Jaya
Address
No. 2, Pluit Raya Street, RT 21/RW 8, Penjaringan District, North Jakarta, Indonesia
Tel
+62216694366
kep.fkik@atmajaya.ac.id
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 | 15 | 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
22
Results
22 participants analyzed. TBUT and OSDI were significantly worse in the intervention group at baseline. No significant between-group differences were observed at Month 1 or Month 3 for TBUT or OSDI. Both groups improved over time, but Omega-3 supplementation did not show a statistically significant advantage. No serious adverse events.
Results date posted
| 2025 | Year | 11 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Treatment group: 11 subjects
Control group: 11 subjects
Age:
- Treatment group: 73.27 +/- 7.04 years
- Control group: 68.81 +/- 6.60 years
Sex distribution:
- Treatment group: 36.4% male (8), 63.6% female (14)
- Control group: 27.3% male (6), 72.7% female (16)
Participant flow
Enrollment
-Total patients screened: 80
- Excluded: 44 (did not meet inclusion criteria / declined participation)
- Included in the study: 36 participants (72 eyes)
Allocation
- Allocated to Therapy Group: 18 participants (36 eyes analyzed)
- Allocated to Control Group: 18 participants (36 eyes analyzed)
Follow-up
- Therapy Group: 7 participants were drop out at month 1 and month 3
- Control Group: 7 participants were drop out at month 1 and month 3
Analysis
-Therapy Group: 11 participants analyzed
-Control Group: 11 participants analyzed
Adverse events
No adverse events were observed during the study.
Outcome measures
Primary Outcome: TBUT score change from baseline to 3 months.
Secondary Outcomes:
1. OSDI change from baseline to 3 months.
2. OSDI score at Month 1 and Month 3.
3. TBUT score at Month 1 and Month 3.
Plan to share IPD
No plan to share IPD
IPD sharing Plan description
Individual participant data will not be shared due to confidentiality concerns and institutional policy
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 03 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 18 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 28 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 28 | Day |
Date trial data considered complete
| 2025 | Year | 01 | Month | 28 | Day |
Date analysis concluded
| 2025 | Year | 05 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 15 | Day |
Last modified on
| 2025 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068363
