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CTRI Number  CTRI/2019/03/018319 [Registered on: 29/03/2019] Trial Registered Prospectively
Last Modified On: 17/12/2019
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   This study compares the effectiveness and safety of the study product cylclosporin against Restasis in patients suffering from moderate to severe dry eye. 
Scientific Title of Study   Phase IV Controlled Clinical Study to Compare the Efficacy and Safety of CYCLOSPORINE (0.05%) Ophthalmic Emulsion against RESTASIS® in Subjects with Moderate to Severe Keratoconjunctivitis Sicca. 
Trial Acronym   
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
NIBP-018-002 Version 2.0 Dated 02 May 2019  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Dr Diptendu Santra 
Designation  Medical Monitor 
Affiliation  JSS Medical Research India Private Limited 
Address  12/2, 6th Floor, Vatika Mindscapes, Sector 27D, Faridabad-121003

Faridabad
HARYANA
121003
India 
Phone  08698065660  
Fax  01296613520  
Email  diptendu.santra@jssresearch.com  
 
Details of Contact Person
Public Query  
Name  Dr Shariq Anwar 
Designation  Head Operations 
Affiliation  JSS Medical Research India Private Limited 
Address  12/2, 6th Floor, Vatika Mindscapes, Sector 27D, Faridabad-121003

Faridabad
HARYANA
121003
India 
Phone  09810979215  
Fax  01296613520  
Email  shariq.anwar@jssresearch.com  
 
Source of Monetary or Material Support  
New India Bio Pharma Pvt Ltd,D-96, East of Kailash New Delhi-110065 India 
 
Primary Sponsor  
Name  New India Bio Pharma Pvt Ltd 
Address  New India Bio Pharma Pvt. Ltd D-96, East of Kailash New Delhi-110065 India  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 7  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Tulika Chauhan  Centre for Sight Eye Institute   IInd Floor Pocket 9, Sector 9, Dwarka 110075
New Delhi
DELHI 		 9535133800

toolika.chauhan@gmail.com 
Dr Nitin Batra  Christian Medical College & Hospital   Room no-26 Floor-2nd Department of Ophthalmology ,Brown Road Ludhiana 141008, Punjab
Ludhiana
PUNJAB 		 09815333665

nbatra2001@gmail.com 
Dr Virender Singh Sangwan  Dr Shroff Charity Eye Hospital   Room no:Quality Department Floor: Ground Building: Dr Shroff Charity Eye Hospital 5027, Kedarnath Ln, Dariya Ganj.
New Delhi
DELHI 		 09849294656
011-43528816
drsangwan.lveip@gmail.com 
Dr Namrata Sharma  Dr.R.P.Centre for Ophthalmic Sciences,  Room no 481, 4th floor, All India Institute of Medical Sciences
South
DELHI 		 011-26593144

namrata.sharma@gmail.com 
Dr Sayan Basu  L V Prasad Eye Institute  Room no 123 Floor:1 Building: GPR Building L.V Prasad Marg, Banjara Hills, Road No: 2
Hyderabad
TELANGANA 		 09989479969
04023548271
sayanbasu@lvpei.org 
Dr Amit gupta  Post Graduate Institute of Medical Sciences & Research  Room no 123 Floor-Ground Floor,Building-Advance Eye Center Department of Ophthalmology
Chandigarh
CHANDIGARH 		 09814286731

amitguptaeye@gmail.com 
Dr A Tarakeswara Rao  Rajiv Gandhi Institute of Medical Sciences & RIMS Govt. General Hospital  Room No 11, Floor 2nd, Building FM ward, Srikakulam-532001
Srikakulam
ANDHRA PRADESH 		 09441873644
08942279033
drtarakrims@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
Centre for Sight Institutional Medical Ethical Committee,  Approved 
Dr Shroff ‘s Charity Eye Hospital Ethics Committee  Approved 
Institutional Ethics Committee,All India Institute of Medical Sciences  Approved 
Institutional Ethics Committee,Christian Medical College & Hospital   Approved 
Institutional Ethics Committee,Post Graduate Institute of Medical Sciences & Research Sector   Approved 
Institutional ethics committee,RIMS Govt Hospital  Approved 
LV Prasad Eye Institute Ethic committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H162||Keratoconjunctivitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  CYCLOSPORINE   One drop of CYCLOSPORINE (0.05%) in each eye to be instilled twice a day (once on waking in the morning and once at bedtime) for one month  
Comparator Agent  RESTASIS®  one drop of RESTASIS® 0.05% (Allergan India., Pvt. Ltd.) to be instilled twice a day in each eye (once on waking in the morning and once at bedtime) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Male or female, between 18 and 65 years of age (both age inclusive).
2.Subjects presenting with documented signs and symptoms of moderate to severe Keratoconjunctivitis sicca (KCS) by diagnostic criteria as per investigators discretion.
3.History of KCS for a period of at least 6 months
4.Lack of clinically adequate improvement despite conventional management, which may have included artificial tear eye drops, topical parasympathomimetic agent’s topical steroids in the affected eye(s).
5. Schirmer Tear Test (ST) score (without anesthesia) ≤ 10 mm/5 min in at least one eye.
6. Positive corneal staining, defined as a corneal fluorescein staining (CFS) score of greater or equal to 4 in either eye by the National Eye Institute (NEI) /Industry Workshop Evaluation scale summed over 5 areas each with a 0-3 scoring scale,where 0 equals to normal,and 3 equals to severe with a maximum total score of 15.
7.Positive conjunctival staining, defined as a conjunctival lissamine green staining (CLGS) score of greater or equal to 4 in either eye by the National Eye Institute (NEI) /Industry Workshop Evaluation scale summed over 3 areas each with a 0-3 scoring scale, where 0 equals to normal and 3 equals to severe with a maximum total score of 18.
8. At least one of the following ocular symptoms scored at ≥2, where a. 0 equals none and 4 equals to very severe/interferes with normal activities- photophobia, blurred vision, foreign body sensation, soreness or pain, itching, burning, dryness.
9.Ocular Surface Disease Index (OSDI) ≥20;)
10.Best corrected visual acuity (BCVA) of 0.7 log MAR or better in each eye as assessed using an ETDRS chart
11.Normal lid position and closure.


 
 
ExclusionCriteria 
Details  1.Present or history (in the preceding 6 months) of any systemic or ocular condition(s) that could possibly interfere with the interpretation of the study results;
2.Any disease of the eye leading to diffuse loss of conjunctiva;
3.Active anterior blepharitis;
4.A history or current evidence of epithelial herpes simplex keratitis (dendritic keratitis); vaccine, active or recent varicella viral disease of the cornea and/or conjunctiva; ocular rosacea; chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal disease of the eye;
5.Current infections of the anterior segment or uveitis;
6.Uncontrolled systemic disease or the presence of any significant illness that can, in the judgment of the Investigator, interfere with interpretation of the study results;
7.Recent use (within 1 month) or anticipated use of temporary punctual plugs during the study;
8.Permanent occlusion of lacrimal puncta within 3 months of the study;
9.Subjects unwilling to discontinue contact lens wear at least one week prior to screening/ baseline visit and during the study duration;
10. Use of RESTASIS® (cyclosporine ophthalmic emulsion, 0.05%) or any other topical and/or systemic cyclosporine within 90 days before the study.
11.Previous treatment failure (lack of efficacy) with cyclosporine ophthalmic emulsion 0.05%.
12. Diagnosis of Sjogren’s disease ˃ 5 years prior to the Screening Visit.
13.Clinical diagnosis or any history of seasonal and/or perennial allergic conjunctivitis.
14.Use of systemic or topical medications within 7 days prior to the Screening Visit or during the study period that are known to cause dry eye.
15. Corneal transplant.
16. Corneal refractive surgery within 6 months prior to the Screening Visit or postoperative refractive surgery symptoms of dryness that have not resolved;
17.Lasik surgery done within 6 months prior to screening visit.
18.Cataract surgery within 3 months prior to the screening visit.



 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Mean change in Corneal Staining Scores  3 months and 6 months of treatment from baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Mean change in Schirmer Tear Test scores (without anaesthesia)  1, 2, 3, and 6 months from
baseline
 
Mean change in Ocular Surface Disease Index Score (OSDI) scores  1, 2, 3, and 6 months from
baseline
 
Mean change in symptom scores  1, 2, 3, and 6 months of treatment from baseline 
Global evaluation of overall effect of study medication  3 month and 6month from baseline 
Clinically significant changes in the ocular examination  6 Months 
Mean change in Corneal Staining Scores  1, 2, 3, and 6 months of treatment from baseline 
Mean change in Conjunctival Staining Scores  1, 2, 3, and 6 months of treatment from baseline 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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   Phase 4 
Date of First Enrollment (India)
Modification(s)  		 20/05/2019 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

 

The study is a phase IV controlled clinical trial, multi centre, randomized, open label, three-arm parallel group active control study in subjects with moderate to severe Keratoconjunctivitis sicca (dry eye disease) in Indian clinical practice setting. The present study has been designed to compare the efficacy and safety of topical formulation of CYCLOSPORINE (0.05%, instilled as twice a day dose in each eye) and CYCLOSPORINE (0.05%, instilled as twice a day dose in each eye for one month and once a day dose in each eye for rest five months) against the US FDA approved and commercially available, topical preparation, RESTASIS® (Allergan India., Pvt. Ltd. instilled as twice a day dose in each eye) by objective and subjective evaluations of tear production, ocular surface integrity, and subject symptoms. Approximately 300 Eyes of subjects diagnosed for moderate to severe dry eye disease and meeting the eligibility criteria, will be randomized (50 subjects in each arm) from approximately 6-8 participating investigators sites across India.


 
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