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.

  • STATUS
    Recruiting
  • days left to enroll
    53
  • participants needed
    666
  • sponsor
    Sun Pharmaceutical Industries Limited
Updated on 16 September 2022
hypertension
glaucoma
ocular hypotensive
brinzolamide
hypotensive
primary open angle glaucoma
azopt
brinzolamide ophthalmic suspension

Summary

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

Details
Condition Primary Open Angle Glaucoma, Ocular Hypertension
Treatment Brinzolamide ophthalmic suspension, Brinzolamide ophthalmic suspension, Azopt®
Clinical Study IdentifierNCT05022004
SponsorSun Pharmaceutical Industries Limited
Last Modified on16 September 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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