A Therapeutic Equivalence Study in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension

Sponsor

Sun Pharmaceutical Industries Limited (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05022004

Collaborator

(none)

666

Enrollment

Locations

Arms

10.4

Anticipated Duration (Months)

16.7

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a randomized, Investigator-masked, multi-center, parallel group, therapeutic equivalence study with clinical endpoint.

Condition or Disease	Intervention/Treatment	Phase
Primary Open Angle Glaucoma Ocular Hypertension	Drug: Brinzolamide ophthalmic suspension Drug: Azopt®	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

666 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

Therapeutic Equivalence Study of Generic Brinzolamide 1% Ophthalmic Suspension Compared to Reference Listed Drug Azopt® (Brinzolamide) Ophthalmic Suspension 1% in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension.

Actual Study Start Date :

Dec 20, 2021

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BRIN-20-01	Drug: Brinzolamide ophthalmic suspension dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks
Active Comparator: Azopt®	Drug: Azopt® dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks

Arm

Intervention/Treatment

Experimental: BRIN-20-01

Drug: Brinzolamide ophthalmic suspension

dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks

Active Comparator: Azopt®

Drug: Azopt®

dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks

Outcome Measures

Primary Outcome Measures

Mean difference in Intraocular Pressure of both eyes between the two treatment groups [Baseline, Week 2 & Week 6]
The outcome measure is exactly what is in the OGD guidance: The recommended primary endpoint is the mean difference in Intraocular Pressure of both eyes between the two treatment groups at pre-specified time points.

Secondary Outcome Measures

Change from baseline in IOP of both eyes between the 2 treatment groups. [approximately 8:00 AM. (hour 0; before the morning drop) and 10:00 AM. (hour 2) at the Day 14 (Week 2) and Day 42 (Week 6) visits]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or nonpregnant female aged 18 years or older with chronic open angle glaucoma or ocular hypertension in both eyes.
Provide signed and dated informed consent in accordance with good clinical practice and local legislation prior to any study procedure.
Be able and willing to follow study instructions and complete all required visits.
Subject requires treatment of both eyes and is able to discontinue use of all ocular hypotensive medication(s) or switch ocular hypotensive medications and undergo appropriate washout period.

Exclusion Criteria:

Subjects with angle closure glaucoma
Females who are pregnant, breast feeding, or planning a pregnancy.
Females of childbearing potential who do not agree to utilize an adequate form of contraception.
Current, or past history of, severe hepatic or renal impairment
Current, or history within 2 months prior to baseline of, significant ocular disease
Functionally significant visual field loss
Contraindication to brinzolamide or sulfonamide therapy or known hypersensitivity to any component of brinzolamide or sulfonamide therapy
Subjects currently in another clinical trial

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GMC, Srikakulam	Srikakulam	Andhra Pradesh	India	532001
2	Dr. RSPR Govt Regional Eye Hospital; Vishakapatnam	Visakhapatnam	Andhra Pradesh	India	530013
3	Rising Retina Clinic	Ahmedabad	Gujarat	India	380015
4	Bhavna Super speciality Eye care	Surat	Gujarat	India	395002
5	Dr. BR Ambedkar Medical College and hospital	Bangalore	Karnataka	India	560045
6	Bhagwan Mahaveer Jain Hospital	Bangalore	Karnataka	India	560052
7	KLE's Dr. Prabhakar Kore Hospital & Medical Research Center	Belgaum	Karnataka	India	590010
8	K R Hospital, Mysore Medical College and Research Institute	Mysuru	Karnataka	India	570001
9	Shanti Saroj Netralay	Miraj	Maharashtra	India	416410
10	Omkar Eye Care Center	Mumbai	Maharashtra	India	400080
11	Acharya Vinoba Bhave Rural Hospital, Jawaharlal Nehru Medical College, Datta Meghe Institute of Medical Sciences	Wardha	Maharashtra	India	442004
12	Sankara Nethralaya	Chennai	Tamil Nadu	India	600006
13	Dr Agarwal's Eye Hospital	Tirunelveli	Tamil Nadu	India	627003
14	Heritage Institute of Medical Sciences	Varanasi	Uttar Pradesh	India	221005
15	Republican clinical ophthalmological hospital of Ministry of Health of Republic of Tatarstan	Kazan	Republic Of Tatarstan	Russian Federation	420012
16	Institute of Human Brain of the Russian Academy of Science, 197376, Academ. Pavlov street 12 AP, StPetersburg, Russia	Saint Petersberg	Saint Petersburg	Russian Federation	197376
17	"Eye Microsurgery" n a Academician S.N. Fedorov",	Cheboksary		Russian Federation	428028
18	Medical Organization "Optic Center"	Chelyabinsk		Russian Federation	454000
19	Eye Microsurgery "Academician S.N. Fedorov"	Irkutsk		Russian Federation	664017
20	Ivanovo Medical academy	Ivanovo		Russian Federation	153040
21	"Eye Microsurgery" n a Academician S.N. Fedorov"	Kaluga		Russian Federation	248007
22	"Eye Microsurgery" n a Academician S.N. Fedorov"	Khabarovsk		Russian Federation	680033
23	FGBOU VO "Moscow Medical-Stomatology University named after A.I. Evdokimov"	Moscow		Russian Federation	111398
24	"Angris", Limited Liability Company (Clinic "Sphere")	Moscow		Russian Federation	117628
25	Moscow Medical university n.a. Sechenov	Moscow		Russian Federation	119021
26	"Eye Microsurgery" n a Academician S.N. Fedorov"	Moscow		Russian Federation	127486
27	"Moscow Regional Clinical Research Institute named after M.F. Vladimirsky"	Moscow		Russian Federation	129110
28	Federal budgetary healthcare institution Privolzhsky district medical center FMBA of Russia.	Nizhny Novgorod		Russian Federation	603074
29	"Eye Microsurgery" n a Academician S.N. Fedorov", Novosibirsk branch	Novosibirsk		Russian Federation	630071
30	Ophthalmological hospital n a V P Vikhodtsev	Omsk		Russian Federation	644024
31	"Eye Microsurgery" n a Academician S.N. Fedorov"	Saint Petersburg		Russian Federation	192283
32	X7 Research Clinical Unit	Saint Petersburg		Russian Federation	194156
33	"The Federal State Budgetary Institution ""North-Western district scientific and clinical center named after L. G. Sokolov Federal Medical and Biological Agency""	Saint Petersburg		Russian Federation	194291
34	Samara medical university	Samara		Russian Federation	443068
35	Private healthcare institution railway medicine.	Saratov		Russian Federation	410004
36	Saratov State Medical University named after V. I. Razumovsky	Saratov		Russian Federation	410012
37	Ufa Eye Research Institute	Ufa		Russian Federation	450008
38	Clinic "Optimed"	Ufa		Russian Federation	453128
39	Ulyanovsk ophthalmology clinical "Prozrenie"	Ulyanovsk		Russian Federation	432001
40	"Eye Microsurgery" n a Academician S.N. Fedorov"	Volgograd		Russian Federation	432001

Sponsors and Collaborators

Sun Pharmaceutical Industries Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sun Pharmaceutical Industries Limited

ClinicalTrials.gov Identifier:

NCT05022004

Other Study ID Numbers:

BRIN-20-01

First Posted:

Aug 26, 2021

Last Update Posted:

Jun 24, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 24, 2022