FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/08/092978 [Registered on: 13/08/2025] Trial Registered Prospectively
Last Modified On: 12/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to assess the effect of treatment on patients with dry eye disease and to compare the two treatment options 
Scientific Title of Study   A comparative study to evaluate clinicopathological changes associated with usage of topical cyclosporine A 0.09 percent versus lifitegrast 5 percent eyedrops in patients with dry eye 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 Pallavi Joshi 
Designation  Cornea Consultant 
Affiliation  Sankara eye hospital 
Address  Cornea Clinic, room no 28, Sankara eye hospital, varthur road, kundalhalli gate

Bangalore
KARNATAKA
560037
India 
Phone  8147280162  
Fax    
Email  drpallavijoshi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mansi Mistry 
Designation  Fellow in Cornea 
Affiliation  Sankara eye hospital 
Address  Cornea clinic, room no 28B, Sankara eye hospital, varthur road, kundalhalli gate

Bangalore
KARNATAKA
560037
India 
Phone  8879624413  
Fax    
Email  drmansimistry@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mansi Mistry 
Designation  Fellow in Cornea 
Affiliation  Sankara eye hospital 
Address  Cornea clinic, room no 28B, Sankara eye hospital, varthur road, kundalhalli gate


KARNATAKA
560037
India 
Phone  8879624413  
Fax    
Email  drmansimistry@gmail.com  
 
Source of Monetary or Material Support  
Sankara eye hospital, varthur road, kundalhalli gate, bangalore 560037 
 
Primary Sponsor  
Name  Sankara eye hospital 
Address  Sankara eye hospital , varthur road, kundalhalli gate, bangalore 560037 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mansi Mistry  Cornea Clinic  Room no 28, cornea clinic, sankara eye hospital, varthur road, kundalhalli gate
Bangalore
KARNATAKA 		 8879624413

drmansimistry@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ehics Committee-Approval letter  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H578||Other specified disorders of eye and adnexa,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Lifitegrast 5 percent  Twice a day dose for 12 weeks 
Intervention  Topical Cyclosporine 0.09 percent  Twice a day for 12 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Mild to moderate dry eye disease
Stain score more than 3 and less than 9
Symptom score more than 7
Patients willing to discontinue current therapy
 
 
ExclusionCriteria 
Details  Patients on immunomodulator therapy within 3 months
Patients with glaucoma, Uveitis, tumors, trauma history
Patients with previous corneal surgery
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Alternation 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Clinical evaluation
Keratograph
Schirmers
TBUT
Corneal and Conjunctival staining score
Patient response score 		 Baseline and week 12 
 
Secondary Outcome  
Outcome  TimePoints 
Pathological evaluation by impression cytology
Conjunctival goblet cell density
Squamous metaplasia
Epithelial integrity 		 Baseline and week 12 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   25/08/2025 
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="2"
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  

This randomized controlled trial aims to evaluate and compare the clinico-pathological changes in patients with Dry Eye Disease  treated with Cyclosporine A 0.09 percentage and Lifitegrast 5 percentage at Sankara Eye Hospital, Bangalore. Dry eye disease is a multifactorial condition marked by tear film instability and ocular surface inflammation. Eligible patients above 18 years with various forms of dry eye disease will undergo a drug-free period before being randomly assigned to either treatment group. Clinical assessment of dryness using Schirmers test, Keratograph, Tear film breakup time, Corneal staining pattern and Symptom score will be checked at baseline and week 12. Impression cytology of the cornea and conjunctiva will be performed at baseline and week 12 to assess squamous metaplasia, goblet cell density, and cellular morphology. The study seeks to correlate clinical improvements with pathological changes, providing insight into the efficacy of these immunomodulatory therapies.

 
Close