UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049192 |
|---|---|
| Receipt number | R000056032 |
| Scientific Title | Omega 3 fatty acids in evaporative dry eye! Are they ineffective? |
| Date of disclosure of the study information | 2023/06/01 |
| Last modified on | 2022/10/11 23:25:34 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Omega 3 fatty acids in dry eye syndrome
Acronym
O3FAs in DES
Scientific Title
Omega 3 fatty acids in evaporative dry eye! Are they ineffective?
Scientific Title:Acronym
O3FAs in evaporative dry eye
Region
| Asia(except Japan) |
Condition
Condition
Dry Eye Syndrome
Classification by specialty
| Medicine in general | Ophthalmology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of Oral omega 3 fatty acids in evaporative dry eye.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
The primary outcome measure was the change from baseline in omega-3 index (a measure of the amount of EPA and DHA in the blood, specifically the red blood cell membranes).
Key secondary outcomes
Secondary outcome measures were subjective dry eye symptoms (a reduction from baseline representing an improvement).
Other outcome measures were a change in tear film osmolarity, the Schirmer test value (increase in the amount of wetting representing an improvement), TBUT (increased time [in sec] representing an improvement), and Nelson grade at day 45 (reduction in the grade representing an improvement). The relation between the time spent in front of the VDT (predictor variable) and the outcome variables was also evaluated.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The O3FA group received 4 capsules, each containing 180 mg of EPA and 120 mg docosahexaenoic acid (DHA), twice daily for 180 days (1,440 mg of EPA +960 mg DHA/day).
Interventions/Control_2
The placebo group received 4 capsules containing olive oil, twice daily for 180 days.
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
| 21 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
A letter was sent to the supervisors in the health management section of regional call-centers, universities, and information technology (IT) companies to explain the study purpose and to
request participation in the study. Three universities, three call-centers, and four IT companies responded and agreed to participate in the study; after reviewing the protocol and potential risks and benefits, permission was granted to conduct the study among employees who were willing. Employees were invited by e-mail to answer a questionnaire; this included information such as demographic characteristics, dietary habits (vegetarian / fish consumer), symptoms experienced, total working hrs, and average hrs spent in VDT work each day during the past year. A maximum of three e-mail reminders were sent. Employees who completed the questionnaire were requested to attend a dry eye clinic for ophthalmic work-up and blood tests. Symptomatic VDT users (those experiencing dry eye symptoms) were identified, and the subjects were enrolled, and grading of dry eye disease was done based on their response to the Indian Dry Eye questionnaire called the Dry Eye Scoring System (DESS), a questionnaire of common symptoms of dry eye
Key exclusion criteria
Patients with allergic conjunctivitis, history of laser in situ keratomileusis, and contact lens wear, or other causes of dry eye in the office-going population, software professionals, or university students were excluded from the study. Patients with inability to swallow soft-gel capsules, those on regular course of aspirin or anticoagulants (cyclooxygenase-2 inhibitors), and those allergic to fluorescein were also excluded. Systemic (tetracyclines and corticosteroids) or topical medications (other than artificial tear supplements) that could affect the tear film or meibomian gland functions (betablockers, benzodiazepines, and antihistamines) were discontinued 3 weeks before intervention. Moreover, patients were instructed not to use artificial tear preparations, 2 hr before testing.
Target sample size
450
Research contact person
Name of lead principal investigator
| 1st name | Rahul |
| Middle name | |
| Last name | Bhargava |
Organization
GS Medical College, Pilkhuwa, UP, India
Division name
Hapur
Zip code
245305
Address
NH-24, Pilkhuwa
TEL
8076020248
dean@gsmedicalcollege.in
Public contact
Name of contact person
| 1st name | Anuj |
| Middle name | |
| Last name | Mehra |
Organization
Anuj safety
Division name
Delhi
Zip code
110092
Address
G-245, Preet Vihar Delhi
TEL
9891277776
Homepage URL
anujsafety@gmail.com
Sponsor or person
Institute
Nil
Institute
Department
Personal name
Funding Source
Organization
Nil
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
GS Medical College
Address
NH-24, Pilkhuwa
Tel
9958657744
kumarprachi@yahoo.co.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
| 2023 | Year | 06 | Month | 01 | 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
| 2022 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2023 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2023 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 11 | Day |
Last modified on
| 2022 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056032
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
