A Therapeutic Equivalence Study in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension (NCT05022004) | Clinical Trial Compass
CompletedPhase 3
A Therapeutic Equivalence Study in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
India599 participantsStarted 2021-12-20
Plain-language summary
This is a randomized, Investigator-masked, multi-center, parallel group, therapeutic equivalence study with clinical endpoint.
Who can participate
Age range18 Years
SexALL
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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
What they're measuring
1
Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups