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Completed

NCT Number: NCT05022004

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

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

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Key information

Conditions

Primary Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GMC, Srikakulam, Srikakulam, Andhra Pradesh, India

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brinzolamide ophthalmic suspension

Drug

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

Azopt®

Drug

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

Primary outcomes

  1. Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups

    Time frame: 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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Sun Pharmaceutical Industries Limited

Industry

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Aug 26, 2021
Registry last updated
Jan 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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