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

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ClinicalTrials.gov Identifier: NCT05022004
Recruitment Status : Recruiting
First Posted : August 26, 2021
Last Update Posted : August 29, 2022
Sponsor:
Information provided by (Responsible Party):
Sun Pharmaceutical Industries Limited

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 20, 2021
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

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




Primary Outcome Measures :
  1. Mean difference in Intraocular Pressure of both eyes between the two treatment groups [ Time Frame: 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 :
  1. Change from baseline in IOP of both eyes between the 2 treatment groups. [ Time Frame: 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05022004


Contacts
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Contact: Head, Clinical Developement 9122 66455645 ext 5689 Clinical.Trial@sunpharma.com

Locations
Show Show 40 study locations
Sponsors and Collaborators
Sun Pharmaceutical Industries Limited
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Responsible Party: Sun Pharmaceutical Industries Limited
ClinicalTrials.gov Identifier: NCT05022004    
Other Study ID Numbers: BRIN-20-01
First Posted: August 26, 2021    Key Record Dates
Last Update Posted: August 29, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Brinzolamide
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action