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CTRI Number  CTRI/2021/08/035991 [Registered on: 27/08/2021] Trial Registered Prospectively
Last Modified On: 18/10/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Bioequivalence study with clinical endpoint comparing Bimatoprost ophthalmic solution 0.01% with LUMIGAN® (Bimatoprost ophthalmic solution) 0.01 % in subjects with chronic open-angle glaucoma or ocular hypertension in both eyes.  
Scientific Title of Study   A randomized (I: I), double-masked, multi-center, two-treatment, parallel design, multiple dose bioequivalence study with clinical endpoint comparing Bimatoprost ophthalmic solution 0.01% of Odin Pharmaceuticals Inc. with LUMIGAN® (Bimatoprost ophthalmic solution) 0.01 % of Allergan, Inc., Irvine, CA 92612, U.S.A in subjects with chronic open-angle glaucoma or ocular hypertension in both eyes.  
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
CBCC/2021/009, Version 1.0 dated 10/May/2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sandeep Singh 
Designation  Vice President - Clinical Operations 
Affiliation  CBCC Global Research LLP 
Address  Clinical Operations Department, Room Number 2, East Wing, Second Floor Skoda House Opposite L J Campus S G Highway Sarkhej Ahmedabad – 382210, India
Ahmedabad
Ahmadabad
GUJARAT
382210
India 
Phone  9637555304  
Fax  9726434204  
Email  sandeep.singh@cbccusa.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sandeep Singh 
Designation  Vice President - Clinical Operations 
Affiliation  CBCC Global Research LLP 
Address  Clinical Operations Department, Room Number 2, East Wing, Second Floor Skoda House Opposite L J Campus S G Highway Sarkhej Ahmedabad – 382210, India
Ahmedabad

GUJARAT
382210
India 
Phone  9637555304  
Fax  9726434204  
Email  sandeep.singh@cbccusa.com  
 
Details of Contact Person
Public Query  
Name  Dr Sandeep Singh 
Designation  Vice President - Clinical Operations 
Affiliation  CBCC Global Research LLP 
Address  Clinical Operations Department, Room Number 2, East Wing, Second Floor Skoda House Opposite L J Campus S G Highway Sarkhej Ahmedabad – 382210, India
Ahmedabad

GUJARAT
382210
India 
Phone  9637555304  
Fax  9726434204  
Email  sandeep.singh@cbccusa.com  
 
Source of Monetary or Material Support  
Odin Pharmaceuticals Inc. Address: 300 Franklin Square Drive, Somerset, NJ 08873  
 
Primary Sponsor  
Name  Odin Pharmaceuticals Inc 
Address  Address: 300 Franklin Square Drive, Somerset, NJ 08873  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
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 Perwez Khan  GSVM Medical Collage   Swaroop Nagar, Kanpur, Uttar Pradesh-208002.India
Kanpur Dehat
UTTAR PRADESH 		 9451875355

perwez.khan@gmail.com 
Dr Vinutha B V  KIMS Hospital and Research Center  Department of Ophthalmology, Opd building Block, Ground Floor, K R Road, V V Puram, Bangalore-560004, Karnataka, India
Bangalore
KARNATAKA 		 9980102212

bidivinutha@gmail.com 
Dr Kamini Prajapati  M & J Western Regional Institute of Ophthalmology   Civil Hospital Campus, Asarwa, Ahmedabad - 380016 Gujarat, India.
Ahmadabad
GUJARAT 		 9428350450

drkamini1@yahoo.com 
Dr Sudhir Kumar Garg  Maharaja Agrasen Hospital  Clinical Research Department, 1st Floor, HR building, Maharaja Agrasen Hospital, West Punjabi Bagh, New Delhi-110026, India
West
DELHI 		 9811411198

drskgi2610@gmail.com 
Dr Rana Parth Jagdishkumar  Netralaya Super Speciality Eye Hospital  101/102 K.D house, Parimal garden cross road, Ellisbridge, Ahmedabad-380006, Gujarat. India.
Ahmadabad
GUJARAT 		 7999999344

dr.parth.rana@gmail.com 
Dr Lakshmi Kanta Mondal  Regional Institute of Ophthalmology  Regional Institute of Ophthalmology, Second floor, room no 301 (Research Room), 88 College Street, Medical college Kolkata 700073, West Bengal, India
Kolkata
WEST BENGAL 		 9830830216

lakshmi.mondal62@gmail.com 
Dr Sonal Patel  The Eye Centre  220, Platinum plaza complex, opp. Rajhans theatre, Nikol, Ahmedabad - 382350, Gujarat, India.
Ahmadabad
GUJARAT 		 9712948419

sonalbipatel@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
Ethics Committee GSVM Medical Collage Kanpur  Approved 
Ethics Committee of CIMS  Approved 
Institutional Ethics Committee B.J. Medical College & Civil Hospital   Approved 
Institutional Ethics Committee Regional Institute Of Ophthalmology  Approved 
Institutional Ethics Committee, Maharaja Agrasen Hospital  Approved 
KIMS Institutional Ethics Committee  Approved 
Shivam Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H401||Open-angle glaucoma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bimatoprost ophthalmic solution, 0.01% of Odin Pharmaceuticals Inc.   Dose: 0.01 %, Frequency: Once in a Day, Route of Administration: one drop of ophthalmic solution in both the eyes, Duration of Therapy: 42 Days 
Comparator Agent  LUMIGAN® (Bimatoprost ophthalmic solution) 0.01% of Allergan, Inc., Irvine, CA 92612, U.S.A  Dose: 0.01 %, Frequency: Once in a Day, Route of Administration: one drop of ophthalmic solution in both the eyes, Duration of Therapy: 42 Days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  1. Subjects willing and able to provide voluntary informed consent and to follow the protocol requirements.
2. Male or non-pregnant females aged greater than or equal to 18 years
3. Subjects with chronic open-angle glaucoma or ocular hypertension in both eyes and on prostaglandin analogue monotherapy
4. Subjects requiring treatment of both the eyes and can discontinue use of all ocular hypotensive medication(s) or switch ocular hypotensive medications and undergo an appropriate washout period.
5. Adequate wash-out period prior to baseline of any ocular hypotensive medication as per the table below (In order to minimize potential risk to subjects due to intraocular pressure (IOP) elevations during the washout period, the investigator may choose to substitute a parasympathomimetic or carbonic anhydrase inhibitor or osmotic agent in place of a prostaglandin; however, all subjects must have discontinued all ocular hypotensive medications for the minimum washout period provided as below)
Parasympathomimetics - 4 days
Carbonic anhydrase inhibitors (systemic or topical) - 4 days
Prostaglandin analogs - 4 weeks
Osmotic agents - 4 days
6. Baseline (Day 0 per hour 0) IOP greater than or equal to 24 mm Hg and less than or equal to 30 mm Hg in each eye and difference in IOP between the eyes is not greater than 5 mm Hg
7. Subjects IOP is likely to be controlled with monotherapy as per the discretion of the investigator
8. Baseline visual acuity equivalent to 20 by 80 uncorrected and 20 by 40 corrected or better in each eye
9. Women of child-bearing potential (defined as women physiologically capable of becoming pregnant, unless they are using an effective contraception method during dosing of the investigational product) practicing any two acceptable contraception methods Acceptable methods of contraception are:
a. Oral or parenteral (injection), patch, or implant hormonal contraception which has been used continuously for at least one month prior to the first dose of study medication
b. Intrauterine device or intrauterine system
c. A double barrier method of contraception (Condom and occlusive cap or condom and spermicidal agent)
d. Male sterilization (at least six months prior to the screening, should be the sole male partner for that subject)
e. Female sterilization (surgical bilateral oophorectomy) or tubal ligation at least six weeks prior to study participation
f. Total abstinence, partial abstinence is not acceptable
10. No history of addiction to any recreational drug or drug dependence or alcohol addiction



 
 
ExclusionCriteria 
Details  1. Hypersensitivity to Bimatoprost or related class of drugs or any of the excipients of the formulation
Exclusion 1. Hypersensitivity to Bimatoprost or related class of drugs or any of the excipients
of the formulation
2. Severe hepatic or renal impairment
3. Current or history within two months prior to the baseline of any other
significant ocular disease, e.g., corneal edema, uveitis, ocular infection, or ocular
trauma in either eye. Note: - Stable myopia, strabismus and cataracts (as per
investigator‟s discretion) will be allowed provided other inclusion/exclusion
criteria are met
4. Current corneal abnormalities that would prevent accurate IOP readings with the
tonometer
5. Functionally significant visual field loss
6. Use of an intraocular corticosteroid implant at any time prior to the baseline
7. Use of contact lens within one week prior to the baseline
8. Use of 1) topical ophthalmic corticosteroid, or 2) topical corticosteroid within
two weeks prior to the baseline
9. Use of 1) systemic/ nasal corticosteroid or 2) high-dose salicylate therapy
defined as 325mg/day taken on three consecutive days, within one month prior
to the baseline
10. Use of intravitreal or subtenon injection of ophthalmic corticosteroid within six
months prior to the baseline
11. Underwent any other intraocular surgery (e.g., cataract surgery) within six months prior to the baseline
12. Underwent refractive surgery, filtering surgery, or laser surgery for IOP
reduction (e.g., laser trabeculoplasty) within twelve months prior to the baseline
13. Amblyopia/only one sighted eye
14. Subjects with a history of IOP previously uncontrolled
on bimatoprost monotherapy
15. Severe retinal disease or other severe ocular pathology, such as glaucomatous
damage with a cup/disk ratio greater than 0.8, split fixation, or functionally
significant (in the investigators‟ opinion) visual field loss
16. Chronic use of any systemic medication that may affect IOP with less than a
three-month stable dosing regimen (i.e., sympathomimetic agents, betaadrenergic
blocking agents, alpha agonists, alpha-adrenergic blocking agents,
calcium channel blockers, angiotensin-converting enzyme inhibitors, etc.)
17. Known history or presence of any uncontrolled systemic disease (e.g.,
cardiovascular disease, hypertension, diabetes mellitus, hepatic impairment, etc.)
18. History of recurrent ocular seasonal allergies within the past two years
19. Any other medical condition or severe intercurrent illness that, in the
investigator‟s opinion, may make it undesirable for the subjects to participate in
the study and would limit adherence to the study‟s requirements
20. Pregnant or lactating woman
21. Subjects with suspected signs and symptoms of COVID-19/confirmed novel
coronavirus infection (COVID-19) or with a recent history (within 14 days) of
contact with any COVID-19 positive subject/isolation/quarantine

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare and assess bioequivalence of Bimatoprost ophthalmic solution
0.01% of Odin Pharmaceuticals Inc. with LUMIGAN® (Bimatoprost ophthalmic
solution) 0.01% of Allergan, Inc., Irvine, CA 92612, U.S.A. in subjects with
chronic open angle glaucoma or ocular hypertension in both the eyes 		 Change from baseline (day 0; week 0) to Day 14 (week 2) and Day 42 (week 6)
visits at three time points, i.e., at 00.00 hours, 04.00 hours (at 4 hours after 00.00
hours), and 08.00 hours (at 8 hours after 00.00 hours) in mean intraocular
pressure (IOP) of both the eyes 
 
Secondary Outcome  
Outcome  TimePoints 
To assess redness of eye (hyperemia) and itchiness (pruritus) with Test product
(A) as compared to Reference product (B)
 		 Day 14 & Day 42 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
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)   23/09/2021 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NONE 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

A randomized (1:1), double-masked, multi-center, two-treatment, parallel design, multiple dose bioequivalence study with clinical endpoint comparing Bimatoprost ophthalmic solution 0.01% of Odin Pharmaceuticals Inc. with LUMIGAN® (Bimatoprost ophthalmic solution) 0.01% of Allergan, Inc., Irvine, CA 92612, U.S.A in subjects with chronic open-angle glaucoma or ocular hypertension in both eyes.

Primary Objective:

To compare and assess bioequivalence of Bimatoprost ophthalmic solution 0.01% of Odin Pharmaceuticals Inc. with LUMIGAN® (Bimatoprost ophthalmic solution) 0.01% of Allergan, Inc., Irvine, CA 92612, U.S.A. in subjects with chronic open angle glaucoma or ocular hypertension in both the eyes.

Secondary Objective:

To assess redness of eye (hyperemia) and itchiness (pruritus) with Test product (A) as compared to Reference product (B)

To monitor the adverse events and to ensure the safety of the subjects

 

 
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