CTRI/2024/02/062212 [Registered on: 01/02/2024] Trial Registered Prospectively
Last Modified On:
25/12/2024
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
BE study with clinical endpoint comparing generic bimatoprost ophthalmic solution 0.01% and LUMIGAN® (bimatoprost ophthalmic solution) 0.01% in the treatment of subjects with chronic open-angle glaucoma or ocular hypertension in both eyes.
Scientific Title of Study
A randomized, double-blind, parallel-group, two-arm, multiple dose, multicenter, bioequivalence study with clinical endpoint comparing generic bimatoprost ophthalmic solution 0.01% and LUMIGAN® (bimatoprost ophthalmic solution) 0.01% in the treatment of subjects with chronic open-angle glaucoma or ocular hypertension in both eyes.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
MW230021, Version: 1.0 dated: 24/Oct/2023
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
TURQUOISE-IV
6th Floor, Sardar Patel Ring Rd,
Opp. Apple Woods, Near Shantipura circle
Ahmadabad GUJARAT 382210 India
Phone
9637555304
Fax
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
TURQUOISE-IV
6th Floor, Sardar Patel Ring Rd,
Opp. Apple Woods, Near Shantipura circle
GUJARAT 382210 India
Phone
9637555304
Fax
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
TURQUOISE-IV
6th Floor, Sardar Patel Ring Rd,
Opp. Apple Woods, Near Shantipura circle
Institutional Ethics Committee, D. Y. Patil Medical college
Approved
Institutional Ethics Committee, Dr. Vasantrao Pawar Medical College
Approved
Institutional Ethics Committee, Jaipur National University of Medical Sciences & Research Centre
Approved
Institutional Ethics Committee, JSS Medical College & Hospital
Approved
Institutional Ethics Committee, Regional Institute of Ophthalmology
Approved
Meditrina Institute Ethics Committee
Approved
Opal Institutional Ethics Committee
Approved
Sangini Hospital 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 Amneal EU, Limited
Dose: 1 drop per day in each eye,
Frequency: Once a day at Night,
Route of Administration: Intraocular,
Duration of Therapy: 42 days
Comparator Agent
LUMIGAN (bimatoprost ophthalmic solution) 0.01% of Allergan USA, Inc., Irvine, CA 92612
Dose: 1 drop per day in each eye, Frequency: Once a day at Night, Route of Administration: Intraocular, Duration of Therapy: 42 days
Inclusion Criteria
Age From
18.00 Year(s)
Age To
75.00 Year(s)
Gender
Both
Details
1. Subjects willing and able to provide voluntary informed consent and to follow protocol requirements.
2. Male or females aged greater than or equal to18 years.
3. Subjects with chronic open-angle glaucoma or ocular hypertension in both eyes
4. Subjects requiring treatment of both eyes and able to discontinue the use of all ocular hypotensive medications or switch ocular hypotensive medications and undergo appropriate washout period.
5. Adequate washout period prior to baseline of any ocular hypotensive medications as per the table below (to minimize potential risk to subjects due to intraocular pressure elevations during the washout period, the Investigator may choose to substitute a parasympathomimetic or carbonic anhydrase inhibitor in place of a sympathomimetic, alpha agonist, beta-adrenergic blocking agent, or prostaglandin, however, all the subjects must have discontinued their ocular hypotensive medications for the minimum washout period provided in the table below).
Parasympathomimetics (eg. pilocarpine, carbachol) 4 days
Carbonic anhydrase inhibitors (systemic or topical) (eg. acetazolamide, dorzolamide hydrochloride, brinzolamide) 4 days
Sympathomimetics (eg. dipivefrin, epinephrine) 2 weeks
Alpha-agonists (eg. apraclonidine, brimonidine tartrate, brimonidine tartrate and brinzolamide combination) 2 weeks
Beta-adrenergic blocking agents (eg. timolol, timolol maleate and dorzolamide hydrochloride combination, timolol maleate and brimonidine tartrate combination, levobunolol, betaxolol, metipranolol, carteolol) 4 weeks
Prostaglandin analogs (eg. latanoprost, travoprost, bimatoprost, tafluprost) 4 weeks
Osmotic agents
(eg. Mannitol, Isosorbide, Glycerin) 4 days
Rho kinase inhibitors (eg. Ripasudil, Netarsudil) 4 weeks
7. Subjects IOP is likely to be controlled with monotherapy as per the Investigators discretion.
8. Baseline best corrected visual acuity equivalent to Snellen acuity of 20 by 100 or better in each eye, using a logarithmic visual acuity chart for testing at 10 feet (3 meters).
9. Women of childbearing potential (defined as women physiologically capable of becoming pregnant unless they are using an effective method of contraception during the dosing of the study drug) practicing any of the following acceptable methods of contraception:
a. Oral or parenteral (injection, patch, or implant) hormonal contraception which has been continuously used for at least 1 month prior to first dose of study medication.
b. Intrauterine device or intrauterine system
c. Double barrier method of contraception (condom and occlusive cap or condom and spermicidal agent)
d. Male sterilization (at least 6 months prior to screening, should be the sole male partner for that subject)
e. Female sterilization (surgical bilateral oophorectomy) or tubal ligation at least 6 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. Female who are pregnant, lactating or planning a pregnancy.
2. Subjects recently diagnosed with open-angle glaucoma or ocular hypertension and who are treatment naive.
3. Contraindication or known hypersensitivity to Bimatoprost, related class of drugs, or any of the excipients of formulation.
4. Current or history of severe hepatic or renal impairment.
5. Current or history within 2 months prior to baseline of any other significant ocular disease, eg. corneal edema, uveitis, ocular infection, or ocular trauma in either eye (Note: stable myopia, strabismus, and cataracts as per the Investigator’s discretion will be allowed provided that the other inclusion or exclusion criteria are met).
6. Current corneal abnormalities that would prevent accurate IOP readings with Goldmann applanation tonometer.
7. Functionally significant visual field loss in the Investigators’ opinion.
8. Subject with corneal grafts.
9. Subject has contraindication to pupil dilation.
10. Use at any time prior to baseline of an intraocular corticosteroid implant.
11. Use of contact lens within 1 week prior to baseline.
12. Use within 2 weeks prior to baseline of 1) a topical ophthalmic corticosteroid or 2) a topical corticosteroid.
13. Use within 1 month prior to baseline of 1) a systemic corticosteroid or 2) high dose salicylate therapy defined as 325 mg per day and taken on 3 consecutive days.
14. Use within 6 months prior to baseline of intravitreal or subtenon injection of ophthalmic corticosteroid.
15. Underwent within 6 months prior to baseline any other intraocular surgery (eg. cataract surgery).
16. Underwent within 12 months prior to baseline any refractive surgery, filtering surgery, or laser surgery for IOP reduction (eg. laser trabeculoplasty).
17. Amblyopia only one sighted eye.
18. Subjects with a history of IOP previously uncontrolled on bimatoprost monotherapy.
19. Significant ocular surface findings (eg. hyperemia or irritation, mild or greater) in either eye found on gross macroscopic or slit lamp examination.
20. Severe retinal disease or other severe ocular pathology, such as glaucomatous damage with a cup or disk ratio greater than 0.8 (not including physiological cupping in the Investigators opinion) or split fixation.
21. Chronic use of any systemic medication that may affect IOP with less than 3 months stable dosing regimen (ie. sympathomimetic agents, beta-adrenergic blocking agents, alpha-agonists, alpha-adrenergic blocking agents, calcium channel blockers, angiotensin-converting enzyme inhibitors, etc.)
23. Known history or presence of any uncontrolled systemic disease (eg. cardiovascular disease, hypertension, diabetes mellitus, hepatic impairment, etc.)
24. History of recurrent ocular seasonal allergies within the past 2 years.
25. Any other medical condition or serious intercurrent illness that, in the Investigators opinion, may make it undesirable for the subject to participate in the study and would limit adherence to the study requirements.
26. Participation in any clinical study within 30 days before the first dose of study drug.
27. Subjects with known history of positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV).
28. Subjects with positive urine pregnancy test.
Method of Generating Random Sequence
Stratified randomization
Method of Concealment
Centralized
Blinding/Masking
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Primary Outcome
Outcome
TimePoints
Mean difference in the IOP of both eyes between the two treatment groups at 3 time points, i.e., at 00.00 hour, 04.00 hours (4 hours ±1 hour after 00.00 hour), and 08.00 hours (8 hours ±1 hour after 00.00 hour) at Day 14 (Week 2) (± 4 days) and Day 42 (Week 6) (± 4 days) visits
00.00 hour, 04.00 hours (4 hours ±1 hour after 00.00 hour), and 08.00 hours (8 hours ±1 hour after 00.00 hour) at Day 14 (Week 2) (± 4 days) and Day 42 (Week 6) (± 4 days) visits
Secondary Outcome
Outcome
TimePoints
The incidence of all adverse events reported during the study will be summarized by treatment group. Test and reference products will be compared for safety by
analyzing nature, severity and frequency of treatment emergent adverse events.
NA
Target Sample Size
Total Sample Size="240" Sample Size from India="174" Final Enrollment numbers achieved (Total)= "240" Final Enrollment numbers achieved (India)="174"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
A randomized, double-blind, parallel-group,
two-arm, multiple dose, multicenter, bioequivalence study with clinical
endpoint comparing generic bimatoprost ophthalmic solution 0.01% and LUMIGAN® (bimatoprost
ophthalmic solution) 0.01% in the treatment of subjects with chronic open-angle
glaucoma or ocular hypertension in both eyes
Primary Objective:
To establish clinical endpoint bioequivalence
between generic Bimatoprost ophthalmic solution 0.01% (test product) and
LUMIGAN® (bimatoprost ophthalmic solution) 0.01% (reference product)
Secondary Objective:
To
compare the safety & tolerability between generic Bimatoprost ophthalmic
solution 0.01% (test product) and LUMIGAN® (bimatoprost ophthalmic solution)
0.01% (reference product)