FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/05/033314 [Registered on: 03/05/2021] Trial Registered Prospectively
Last Modified On: 10/12/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   A study of tacrolimus lipid suspension in adult patients of allergic conjunctivitis 
Scientific Title of Study   An open-label, single-arm clinical study to evaluate efficacy, safety and tolerability of tacrolimus lipid suspension for ophthalmic drops in adult patients of allergic conjunctivitis refractory to standard treatment 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
347-13, Version 2.0 Dated 21 June 2016  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prashant Modi 
Designation  Sr. General Manager 
Affiliation  Lambda Therapeutic Research Ltd 
Address  Lambda House, Department of Project Management & Regulatory Affairs, Plot No. 38, Survey No. 388 Near Silver Oak Club, S. G. Highway, Gota

Ahmadabad
GUJARAT
382481
India 
Phone  07940202375  
Fax  07940202021  
Email  prashantmodi@lambda-cro.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Naman Shah 
Designation  General Manager 
Affiliation  Lambda Therapeutic Research Ltd 
Address  Lambda House, Department of CTM Medical Services, Plot No. 38, Survey No. 388 Near Silver Oak Club, S. G. Highway, Gota

Ahmadabad
GUJARAT
382481
India 
Phone  07940202389  
Fax  07940202021  
Email  namanshah@lambda-cro.com  
 
Details of Contact Person
Public Query  
Name  Prashant Modi 
Designation  Sr. General Manager 
Affiliation  Lambda Therapeutic Research Ltd 
Address  Lambda House, Department of Project Management & Regulatory Affairs, Plot No. 38, Survey No. 388 Near Silver Oak Club, S. G. Highway, Gota

Ahmadabad
GUJARAT
382481
India 
Phone  07940202375  
Fax  07940202021  
Email  prashantmodi@lambda-cro.com  
 
Source of Monetary or Material Support  
Intas Pharmaceuticals Ltd., 2nd Floor, Chinubhai Center, Ashram Road, Ahmedabad 380009, Gujarat, India, Tel. No.: 0792657-6655, Fax: 07926578862. 
 
Primary Sponsor  
Name  Intas Pharmaceuticals Ltd 
Address  2nd Floor, Chinubhai Center, Ashram Road, Ahmedabad 380009, Gujarat, India, Tel. No.: 0792657-6655, Fax: 07926578862 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 8  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Uday Gajiwala  Divyajyoti Trust Tejas Eye Hospital  Department of Clinical Research, Room no. NA, Division: NA, Divyajyoti Trust Tejas Eye Hospital, Suthar Falia,Opposite Hanuman Temple,At & Po Mandvi, District-394160
Surat
GUJARAT 		 9979461646

divyajyoti.icare@gmail.com 
Dr Abha Gour  Dr. Shroff s Charity Eye Hospital  Department of Clinical Research, Room no. NA, Division: NA, Dr. Shroff s Charity Eye Hospital, 5027 Kedarnath Lane, Daryaganj -110002
New Delhi
DELHI 		 9971464684

abhagour@gmail.com 
Dr Deepika Singhal  GMERS Medical College and Civil Hospital  Department of Clinical Research, Room no. NA, Division: NA, GMERS Medical College and Civil Hospital ,Near Gujarat High Court , S.G. Highway, Sola- 380061
Ahmadabad
GUJARAT 		 9426541167

deepika1103@yahoo.com 
Dr Sujata Das  LV Prasad Eye Institute  Department of Clinical Research, Room no. NA, Division: NA, LV Prasad Eye Institute, Mithu Tulsi Chenrai Campus, At Patia,PO-KIIT, Bhubaneswar-751024
Khordha
ORISSA 		 9437009411

sujatadas@lvpei.org 
Dr Vineet Pramod Joshi  LV Prasad Eye Institute  Department of Clinical Research, Room no. NA, Division: NA, LV Prasad Eye Institute, Kallam Anji Reddy Campus, Banjara Hills,Road No. 2, 500034
Hyderabad
TELANGANA 		 9597095544

vineet@lvpei.net 
Dr Raminder Singh  Occura Eye Care and Research Center  Department of Clinical Research, Room no. NA, Division: NA, Plot 195, Rajpath Club Road, opposite Kensuille Golf Academy- 380059
Ahmadabad
GUJARAT 		 9998055807

info.occuraeyecare@gmail.com 
Dr Sajani Shah  Sanjivani Super Speciality Hospital   Department of Clinical Research, Room no. NA, Sanjivani Super Speciality Hospital # 1, Udaya Park Society, Near Sunrise Park, Vastrapur Lake Corner, Ahmedabad - Gujarat ·380015
Ahmadabad
GUJARAT 		 9898096016

dr_skshah@yahoo.co.in 
Dr Deepti Swapnil Bharambe  Sarakshi Netralaya  Department of Clinical Research, Room no. NA, Sarakshi Netralaya, 19 Rajiv Nagar, Wardha road, Nagpur-440025
Nagpur
MAHARASHTRA 		 9545975185

taleledp@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 8  
Name of Committee  Approval Status 
Aceas Independent Ethics Committee, Dr. Raminder Singh  Approved 
Dr. Shroff s Charity Eye Hospital Ethics Committee, Dr Abha Gour  Submittted/Under Review 
Institutional Ethics Committee, LV Prasad Eye Institute, Dr Sujata Das  Approved 
Institutional Ethics Committee,GMERS Medical College and Civil Hospital, Dr Deepika Singhal  Approved 
Institutional Ethics Committee-Divyajyoti Trust Tejas Eye Hospital, Dr Uday Gajiwala  Approved 
LV Prasad Eye Institute Ethics Committee, Dr. Vineet Pramod Joshi  Approved 
Sanjivani Hospital Ethics Committee, Dr. Sajani Shah  Approved 
Triveni Polyclinic Institutional Ethics committee, Dr. Deepti Swapnil Bharambe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H104||Chronic conjunctivitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  Tacrolimus lipid suspension for ophthalmic drops 0.005%, manufactured by Intas Pharmaceuticals Ltd., India.  Dose: One drop to be instilled in each eye; Frequency: twice daily; Mode of administration: eye drops; Duration: 4 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Clinical diagnosis of bilateral allergic conjunctivitis (AC) made by an experienced ophthalmologist following recording of symptoms based on complete ophthalmic examination as per standard clinical practice using determination of visual acuity, slit-lamp biomicroscopy and indirect ophthalmoscopy, whenever required.

2. Not responsive to treatment with first line therapeutic agents for sufficient duration as per the best discretion of the Investigator which must include cold compress, artificial tears, topical over the counter preparations, anti-histaminics, mast cell stabilizers and / or topical corticosteroids depending upon the severity of disease

3. Female subjects of childbearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy test at the start of treatment.

4. Surgically sterile, post-menopausal, or sexually abstinent patient or partner must agree to use a medically appropriate form of birth control from screening until 14 + 2 day after the last dose of study medication.

5. The patients who are able to understand and sign a written informed consent form, which is obtained prior to initiation of study procedures. 
 
ExclusionCriteria 
Details  1.Presence of co-existing ocular diseases such as glaucoma, dry eye syndrome, uveitis, ocular infection.
2.Presence of systemic diseases other than co-existing allergic rhinitis, asthma and atopic dermatitis.
3.Patient with ocular structural abnormalities like lid scarring, entropion, trichiasis, etc.
4.Reported hypersensitivity to Tacrolimus or cyclosporine or have a history of serious AEs related to their use.
5.Patients wearing contact lenses.
6.Patients who could not discontinue receiving ocular vasoconstrictor and ocular nonsteroidal anti-inflammatory drugs at the start of study drug administration.
7.Patients who underwent cryosurgery or surgical excision of giant papillae of the eye(s) to which the study drug was to be instilled within 4 weeks prior to the start of study drug administration.
8.Patients who were receiving desensitization therapy or immune modulation therapy in any form 4 weeks prior to the start of study drug administration.
9.Patients who had cataract as a complication in the eye(s) to which the study drug was/were to be instilled, making it impossible to perform fundoscopy by mydriasis.
10.Expecting mothers, lactating mothers, or women wishing to become pregnant.
11.Patients with malignant tumors either as a concomitant disease or a history. (Patients in whom malignant tumors had not recurred more than for 10 years are eligible).
12.Patients with systemic infectious disease.
13.Patients who are receiving treatment requiring hospitalization.
14.History of chemical substance abuse.
15.Patients with repeated anti-inflammatory drug treatment
16.Any condition which the study physician judges to preclude safe participation in the study or to confound the evaluation of the study outcome.
17.Patients who had participated in any other clinical or post-marketing studies (not only for study drugs but also for medical devices) before 60 days from the day of screening. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement (in the form of mean percentage change) from baseline in redness score (using the 4-point standardized rating scale) and itching score (using the 5-point standardized rating scale) at week 4 in each affected eye  At week 4 
 
Secondary Outcome  
Outcome  TimePoints 
- Improvement from baseline in allergic conjunctivitis as per physician s and patient s evaluation of global efficacy at week 4 in each affected eye.
- Improvement in total scoring of ocular signs and symptoms at week 4 against baseline in each affected eye.
- No. of patients in need of rescue medication.
- Relapse rate up to 2 weeks after discontinuation of study treatment as determined by Physician s and patient s evaluation of global efficacy and patient s grading of symptoms  		 At week 4 and up to 2 weeks after discontinuation of study treatment 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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 2 
Date of First Enrollment (India)   10/05/2021 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
This is an open-label, single-arm clinical study to evaluate efficacy, safety and tolerability of tacrolimus lipid suspension for ophthalmic drops in adult patients of allergic conjunctivitis refractory to standard treatment. 
 
Close