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CTRI Number  CTRI/2022/01/039630 [Registered on: 21/01/2022] Trial Registered Prospectively
Last Modified On: 03/09/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of the efficacy between immunomodulator drugs in moderate to severe Dry eye 
Scientific Title of Study   To compare the safety and efficacy of Topical Cyclosporin a (0.05%) with Topical Tacrolimus (0.03%), In patients of moderate to severe dry Eye 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ashis Majumdar 
Designation  Senior Resident 
Affiliation  Regional institute of ophthalmology, Kolkata 
Address  Regional institute of ophthalmology 2nd floor Medical College and hospital Kolkata campus 88, College Street

Kolkata
WEST BENGAL
700073
India 
Phone  08013475473  
Fax    
Email  ashismajumdar5792@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Jayanta Dutta 
Designation  Associate professor 
Affiliation  Purulia Government Medical College and Hospital 
Address  Hatuara, Purulia Department of Ophthalmology Division cornea and refractive surgery Room No - 1

Puruliya
WEST BENGAL
723147
India 
Phone  9433571337  
Fax    
Email  docjayantadutta@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Ashis Majumdar 
Designation  Senior Resident 
Affiliation  Regional institute of ophthalmology, Kolkata 
Address  Department of Ophthalmology Division - Cornea and refractive Surgery 2nd floor, room no - 301 Medical college and hospital campus 88, college street

Kolkata
WEST BENGAL
700073
India 
Phone  8013475473  
Fax    
Email  ashismajumdar5792@gmail.com  
 
Source of Monetary or Material Support  
Regional Institute of Ophthalmology, Kolkata 
 
Primary Sponsor  
Name  Regional Institute of Ophthalmology Kolkata 
Address  Regional institute of ophthalmology,2nd floor 88, College Street Medical College and Hospital, Kolkata campus Kolkata - 700073 
Type of Sponsor  Government medical college 
 
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 
Ashis Majumdar  Regional Institute of Ophthalmology, Kolkata  2nd floor, Room number - 301 Medical College and Hospital Kolkata campus Department of ophthalmology Division - Cornea and refractive surgery
Kolkata
WEST BENGAL 		 08013475473

ashismajumdar5792@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H188||Other specified disorders of cornea,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Topical Cyclosporin A (0.05%) Eye drop  1 drop BD, topical for 6 months 
Comparator Agent  Topical Tacrolimus (0.03%) eye ointment  rice grain sized amount, OD, topical for 6 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  74.00 Year(s)
Gender  Both 
Details  1. Patients with Dry eye symptoms such as Discomfort, Fatigue and Gritty sensation
2. Schirmer’s Test <10mm in 5 minutes
3. TBUT <10 sec
4. OSDI score > 15
5. Presence of Punctate staining in the Fluorescence staining of the cornea, NEI score > 3 
 
ExclusionCriteria 
Details  1. Previous Eye Surgery
2. Use of ocular medication other than tear substitutes.
3. Contact lens wearer
4. Glaucoma patients
5. Pregnant or Lactating Mothers
6. Presence of any microbial infection 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the improvement of OSDI score, schirmer I score, TBUT and NEI score in both group  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
To study prospectively the epidemiological scenario of dry eye in eastern India.  6 months 
To assess the improvement the dry eye state of the symptomatic patients.  6 months 
To assess the symptomatic improvement of dry eye disease patients with the above treatments.  6 months 
To assess the visual outcome after the treatment.  6 months 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= "150"
Final Enrollment numbers achieved (India)="150" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/02/2022 
Date of Study Completion (India) 19/07/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  		 Study Design: Institution based, Proscpective, Interventional, double blinded, Randomised, parallel group, active controlled

Study Setting: OPD and Cornea Clinic at Regional Institute of Ophthalmology (RIO), Kolkata.

Period of Study: 6 months (January, 2022 – August, 2022).

Study Population: Patients of Dry Eye presenting at OPD and Cornea clinic of RIO, Kolkata.

Sample Size: 150 patients (75 in each group)
[Sample size is evaluated on the basis of prevalence of Dry Eye patients in Cornea Clinic and OPD in RIO.]

Inclusion Criteria:
1. Patients with Dry eye symptoms such as Discomfort, Fatigue and Gritty sensation
2. Schirmer’s Test <10mm in 5 minutes
3. tBUT <10 sec
4. Presence of Punctate staining in the Fluorescence NEI score > 3
5. OSDI score > 15

Exclusion Criteria:
1. Previous Eye Surgery
2. Use of ocular medication other than tear substitutes.
3. Contact lens wearer
4. Glaucoma patients
5. Pregnant or Lactating Mothers
6. Presence of any microbial infection.

Study Technique and data collection:
1. History taking.
2. Discomfort scoring by OSDI Questionnaire as a screening survey for Dry Eye.
3. Clinical examination.
4. Ocular Surface evaluation done by Fluorescent staining for corneal damage.
5. Relevant investigation.
6. Tear evaluation by Schirmer’s test under topical anesthesia Paracain drop with standard tear strip kept in conjunctival sac for 5 min.
7. Tear evaluation will be done by tBUT test.
8. Proper Slit Lamp examination to evaluate ocular adnexa and ocular surface.

Study Tools:
1. OSDI Questionnaire
2. Slit Lamp
3. Fluorescent Strip
4. Schirmer Strip

Investigations:
1. Schirmer’s test
2. tBUT test
3. Slit Lamp Examination

STATISTICAL ANALYSIS PLAN
All statistical analysis will be done using IBM SPSS (Statistical Package for the Social Sciences)

SELECTION OF CASES
Subjects presenting with Moderate to Severe Dry Eye at the RIO OPD and cornea clinic, Medical College and Hospital Kolkata and satisfying all the inclusion and exclusion criteria wee selected as cases. These pools of patients are divided into two groups randomly and they were given Topical Cyclosporin A (0.05%) and Topical Tacrolimus (0.03%) and followed up for a period of 6 months.

DATA COLLECTION
Data collection will be done with the help of a OSDI questionnaire containing detailed history and examination. Examination will be carried out with the help of Schirmer’s test, tBUT test, Slit Lamp Examination.

PARAMETERS AND PROCEDURES
1. History taking.
2. Discomfort scoring by OSDI Questionnaire as a screening survey for Dry Eye.
3. Clinical examination.
4. Ocular Surface evaluation done by Fluorescent staining for corneal damage.
5. Relevant investigation.
6. Tear evaluation by Schirmer’s test under topical anesthesia Paracain drop with standard tear strip kept in conjunctival sac for 5 min.
7. Tear evaluation will be done by tBUT test.
8. Proper Slit Lamp examination to evaluate ocular adnexa and ocular surface.

FOLLOW UP
0 visit, 1st week, 1st month, 3rd month,
In all subsequent visits tear evaluation done by Schirmer’s test and tBUT test, Ocular Surface evaluation done by Fluorescent staining for corneal damage, slit lamp examination to evaluate ocular adnexa and ocular surface.


 
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