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CTRI Number  CTRI/2025/08/093557 [Registered on: 25/08/2025] Trial Registered Prospectively
Last Modified On: 22/08/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Effectiveness of Immune-Suppressants for Dry Eyes in Sjögren’s 
Scientific Title of Study   Effectiveness of systemic immunosuppressants for Dry-eyes in Sjogren disease. 
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 Smruti Rekha Priyadarshini 
Designation  Consultant Ophthalmologist, Cornea and anterior segment services 
Affiliation  L V Prasad Eye Institute 
Address  L V Prasad Eye Institute, Mithu Tulsi Chanrai Campus, Cornea and anterior segment services Department, Patia, Bhubaneswar Khordha ORISSA 751024 India

Khordha
ORISSA
751024
India 
Phone  7894384444  
Fax    
Email  drsmruti@lvpei.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Smruti Rekha Priyadarshini 
Designation  Consultant Ophthalmologist, Cornea and anterior segment services 
Affiliation  L V Prasad Eye Institute 
Address  L V Prasad Eye Institute, Mithu Tulsi Chanrai Campus, Cornea and anterior segment services Department, Patia, Bhubaneswar Khordha ORISSA 751024 India


ORISSA
751024
India 
Phone  7894384444  
Fax    
Email  drsmruti@lvpei.org  
 
Details of Contact Person
Public Query  
Name  Dr Smruti Rekha Priyadarshini 
Designation  Consultant Ophthalmologist, Cornea and anterior segment services 
Affiliation  L V Prasad Eye Institute 
Address  L V Prasad Eye Institute, Mithu Tulsi Chanrai Campus, Cornea and anterior segment services Department, Patia, Bhubaneswar Khordha ORISSA 751024 India


ORISSA
751024
India 
Phone  7894384444  
Fax    
Email  drsmruti@lvpei.org  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Hyderabad Eye Research Foundation 
Address  L.V Prasad Eye Institute, MTC Campus, Patia, Bhubaneswar, Pin- 751024, India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sakir Ahmed  Kalinga Institute of Medical Sciences  Clinical Immunology & Rheumatology Department, Patia, Bhubaneswar Odisha, India – 751024
Khordha
ORISSA 		 7077775251

sakir005@gmail.com 
Dr Smruti Rekha Priyadarshini  L V Prasad Eye Institute  Mithu Tulsi Chanrai Campus, Cornea & Anterior Segment Services Department, Patia, Bhubaneswar Khordha, ORISSA, 751024, India
Khordha
ORISSA 		 7894384444

drsmruti@lvpei.org 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee  Submittted/Under Review 
Institutional Ethics Committee-KIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M350||Sicca syndrome [Sjogren],  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Diagnosis of Sjogrens syndrome based on the American European Consensus Group 2002 revised criteria which requires the presence of at least 4 of 6 criteria or 3 of 4 objective criteria.

The 6 criteria include
- subjective and objective ocular dryness

- subjective and objective evidence of salivary gland involvement (as determined by sialometry, sialography, or salivary gland scintigraphy) -presence of SSA/Ro, SSB/La, or both

-positive minor salivary gland biopsy.

A mandatory criterion for the diagnosis of primary SS was either positive serology (SSA or SSB) or positive minor salivary gland biopsy result. 
 
ExclusionCriteria 
Details  - Pregnant and nursing mothers

- Ocular infections, and ocular or refractive surgery in the last three months

- Trauma to the globe, contact lens users.

- Chronic users of any systemic or topical drugs causing dry eyes, such as antihistamines, anticholinergics, beta-blockers, diuretics, antidepressants, antipsychotics, and hormone replacement therapy, birth control pills or intrauterine devices (IUD)

- Women with surgical menopause, the paediatric population, and psychiatric patients 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in symptoms (OSDI) and signs (Ocular surface staining scores) at 6 months as compared with baseline. A minimum of 10% reduction will be taken as improvement.  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. Improvement in OSDI and in Ocular surface staining scores at 3 and 12 months
2. Improvement in Schirmer and Flourescein break-up score at 3, 6 and 12 months
3. Reduced frequency of adjuvants (lubricants) at 3, 6 and 12 months 		 3,6 and 12 months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   08/09/2025 
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)  Open to Recruitment 
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  

This will be a prospective, observational, non-randomized study to determine the effectiveness of systemic immunosuppressants for dry eyes in Sjogren’s disease. The study will commence only after receiving IEC approval.

Rationale for the present study:

Although topical immunosuppressants are a standard of care for dry eyes in Sjogren’s, current literature is unclear about the benefit of systemic immunosuppression. Knowledge about effective immunotherapy for dry eyes, as well as predicting which patients will respond, may dramatically change the management of this challenging condition.

Study Procedure:

All diagnosed cases of Sjogren’s syndrome, according to the diagnostic criteria and started on oral medications by a rheumatologist and topical medications by an ophthalmologist, will undergo:

OSDI questionnaire, Schirmer I test (without anesthesia), Ocular Surface Analyzer (IDRA), Fluorescein Breakup Time (FBUT), Ocular Surface Staining Score (Fluorescein for cornea and Lissamine green staining for conjunctiva), direct assessment of tear secretion (DATS), labial mucosal staining, and diffuse slit lamp photography.

All parameters will be quantitatively measured and compared to baseline at 3-month, 6-month, 9-month, and 1-year intervals.

Pharmacological Agents:

1. Systemic immunomodulators as per the requirements for systemic disease. (This will be as per the treating rheumatologist, and no changes will be made for the sake of this study.)

2. Topical preservative-free lubricants plus topical Cyclosporine 0.09%, as prescribed by the treating ophthalmologist.

 
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