Phase 3
N=597
A Therapeutic Equivalence Study in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
Primary Open Angle Glaucoma · Ocular Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT05022004 ↗Enrolled (actual)
597
Serious AEs
0.2%
Results posted
Jan 2024
Primary outcome: Primary: Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups — 24.92; 25.06; 24.87; 25.12 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Brinzolamide ophthalmic suspension (Drug); Azopt® (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sun Pharmaceutical Industries Limited
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups |
24.92; 25.06; 24.87; 25.12; 24.54; 24.83 | — |
| SECONDARY Change From Baseline in IOP of Both Eyes Between the 2 Treatment Groups. |
-4.67; -5.27; -4.71; -5.28; -5.68; -6.44 | 0.0015 sig |
Summary
This is a randomized, Investigator-masked, multi-center, parallel group, therapeutic equivalence study with clinical endpoint.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT05022004). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.