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

Phase 3

Completed

• Conditions: Primary Open Angle Glaucoma; Ocular Hypertension
• Interventions: Drug: Brinzolamide ophthalmic suspension; Drug: Azopt®

• Registration Number: NCT05022004
• Lead Sponsor: Sun Pharmaceutical Industries Limited

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-19
• Study First Submitted QC: 2021-08-19
• Study First Posted: 2021-08-26
• Study Start: 2021-12-20
• Primary Completion: 2022-12-29
• Study Completion: 2023-01-06
• Status Verified: 2023-12
• Results First Submitted: 2023-12-22
• Results First Submitted QC: 2023-12-22
• Last Update Submitted: 2023-12-22
• Results First Posted: 2024-01-18
• Last Update Posted: 2024-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 599

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BRIN-20-01	Brinzolamide ophthalmic suspension	-
Azopt®	Azopt®	-

Primary Outcome Measures

Name	Time	Method
Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups	Baseline, Week 2 & Week 6	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

Name	Time	Method
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

Trial Locations

Locations (34)

GMC, Srikakulam; 🇮🇳 Srikakulam, Andhra Pradesh, India

Dr. RSPR Govt Regional Eye Hospital; Vishakapatnam; 🇮🇳 Visakhapatnam, Andhra Pradesh, India

Rising Retina Clinic; 🇮🇳 Ahmedabad, Gujarat, India

Bhavna Super speciality Eye care; 🇮🇳 Surat, Gujarat, India

Dr. BR Ambedkar Medical College and hospital; 🇮🇳 Bangalore, Karnataka, India

Bhagwan Mahaveer Jain Hospital; 🇮🇳 Bangalore, Karnataka, India

KLE's Dr. Prabhakar Kore Hospital & Medical Research Center; 🇮🇳 Belgaum, Karnataka, India

K R Hospital, Mysore Medical College and Research Institute; 🇮🇳 Mysuru, Karnataka, India

Shanti Saroj Netralay; 🇮🇳 Miraj, Maharashtra, India

Omkar Eye Care Center; 🇮🇳 Mumbai, Maharashtra, India

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