| CTRI Number |
CTRI/2025/08/093306 [Registered on: 20/08/2025] Trial Registered Prospectively |
| Last Modified On: |
16/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessement of dry eye disease in patients of rheumatoid arthritis |
|
Scientific Title of Study
|
Assessement of dry eye disease in patients of rheumatoid arthritis |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sumeet Singla |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no. 126, 1st floor,medicine department,BL Taneja
block,MAMC,New Delhi
Central
DELHI
110002
India
Central
DELHI
110002
India |
| Phone |
9810104431 |
| Fax |
|
| Email |
sumeetsingla555@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumeet Singla |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no. 126, 1st floor,medicine department,BL Taneja
block,MAMC,New Delhi
Central
DELHI
110002
India
Central
DELHI
110002
India |
| Phone |
9810104431 |
| Fax |
|
| Email |
sumeetsingla555@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vardan Johari |
| Designation |
Post graduate |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no. 126, 1st floor,medicine department,BL Taneja
block,MAMC,New Delhi
Central
DELHI
110002
India
Central
DELHI
110002
India |
| Phone |
8917304190 |
| Fax |
|
| Email |
vardanjohari8860@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College and associated lok nayak hospital,G.I.P.M.E.R, And G.N.E.C.
Hospitals, New Delhi-110002 New Delhi,Delhi |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Maulana Azad Medical College and associated Lok Nayak
hospital,G.I.P.M.E.R and G.N.E.C Hospital ,New Delhi-110002
|
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vardan Johari |
Lok Nayak Hospital |
Maulana Azad Medical
College and associated
lok nayak
hospital,G.I.P.M.E.R,
And G.N.E.C.
Hospitals, New
Delhi-110002 New
Delhi,Delhi
Central
DELHI
Central
DELHI |
8917304190
vardanjohari8860@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College And Associated College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M056||Rheumatoid arthritis with involvement of other organs and systems, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients classified as rheumatoid arthritis as per ACR/EULAR 2010 criteria |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the proportion of Dry Eye Disease and ocular surface damage in patients of Rheumatoid arthritis. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To determine the types of DED – aqueous tear deficiency, evaporative dry eye or mixed DED
2. To determine the clinical and laboratory correlates of DED
3. To compare and see which test(s) [subjective and/or objective] can detect the largest number of patients of RA who have DED |
1 year |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/09/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Rheumatoid arthritic is a chronic inflammatory condition. The occurrence of dry eye disease cannot be correlated with the severity of RA, so the evaluation of the DED should be done in all patients of RA regardless of the severity My study plans to determine the proportion of dry eye disease and ocular surface damage in patients of Rheumatoid arthritis.It also plans to determine the Clinical and laboratory correlates of DED. It also plans to compare which subjective and/or objective test can detect the largest number of RA patient who have dry eye disease.
|