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临床试验/CTRI/2023/06/054478
CTRI/2023/06/054478已完成Unknown

A multicenter, randomized, assessor-blinded, active controlled, parallel group, two arm, non-inferiority clinical trial for the comparison of efficacy and safety of a preservative-free Brinzolamide 10mg/ml + Brimonidine tartrate 2 mg/ml eye drops suspension (AZAD Pharma AG, Switzerland) and Simbrinza® (Brinzolamide 10 mg/ml + Brimonidine tartrate 2 mg/ml) eye drops suspension (Novartis Europharm Limited, Ireland ) in the treatment of elevated intraocular pressure in adult patients with open-angle glaucoma or ocular hypertension.

AZAD Pharma AG0 个研究点目标入组 208 人开始时间: 待定最近更新:
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试验速览

阶段
Unknown
状态
已完成
入组人数
208
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • •1. Male and female patients, aged 18-75 years (both inclusive), diagnosed with bilateral or unilateral open-angle glaucoma or ocular hypertension, who in the opinion of the Investigator, were insufficiently controlled on monotherapy or were already on multiple IOP lowering medications.
  • •2. Mean IOP measurements in at least one eye (the same eye), must have been:
  • •? = 24 mmHg and = 36 mmHg at the 9 a.m. time point, and
  • •? = 21 mmHg and = 36 mmHg at the 11 a.m. time point at both the Eligibility 1 and Eligibility 2 visits
  • •following washout of any IOP-lowering medication.
  • •? Mean IOP must not have been > 36 mmHg in either eye at any time point.
  • •3. Adequate wash-out period prior to baseline of any ocular hypotensive medication.
  • •4. Patients must have provided IEC approved written informed consent using the latest version of the IEC informed consent form.
  • •5. Patients must be in good health and free from any clinically significant disease apart from indication under study.
  • •6. Patients able to comply with study procedures in the opinion of the investigator.
  • •7. Study patients must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required scheduled study visits.
  • •8. Patients must be able to safely discontinue use of all ocular hypotensive medication(s) and undergo appropriate washout period.
  • •9. Sexually active women, unless surgically sterile (at least 6 months prior to study drug administration).

排除标准

  • •1. Pregnant or lactating females.
  • •2. Chronic, recurrent or severe inflammatory eye disease.
  • •3. Severe central visual field loss (i.e., sensitivity =10 dB in =2 of the 4 visual field test points closest to the point of fixation) in either eye.
  • •4. Schaffer angle grade <2 degree in either eye (as measured by gonioscopy).
  • •5. Cup-to-disc ratio >0.80 (horizontal or vertical measurement) in either eye.
  • •6. Best corrected visual acuity (BCVA) score worse than 55 ETDRS letters (20/80 Snellen equivalent).
  • •7. Unable to safely discontinue IOP-lowering ocular medications per the washout schedule.
  • •8. Current or history within 3 months prior to baseline of significant ocular disease, e.g., corneal edema, uveitis, ocular infection, ocular inflammation, corneal ulcerin either eye or corneal foreign body.
  • •9. Ocular trauma within the preceding 6 months.
  • •10. Contraindication to brimonidine tartrate, brinzolamide or sulfonamide therapy or known hypersensitivity to sulfonides or any component of brimonidine tartrate and brinzolamide ophthalmic suspension.
  • •11. Use of intraocular corticosteroid implant at any time prior to baseline.
  • •12. Use of contact lens within one week prior to baseline.
  • •13. Ocular laser surgery within the 3 months prior to entry.
  • •14. Use within two weeks prior to baseline of: 1) topical ophthalmic corticosteroid, or 2) topical corticosteroid.
  • •15. Use within one month prior to baseline of:
  • •1) systemic corticosteroid or
  • •2) high-dose (more than 1 g daily) salicylate therapy
  • •3) monoamine oxidase(MAO) inhibitor therapy,
  • •4) any antidepressant which affects noradrenergic transmission (e.g. tricyclic antidepressants,
  • •mianserin) or
  • •5) adrenergic–augmenting psychotropic drug (e.g. desipramine, amitriptyline).
  • •16. Use within six months prior to baseline of intravitreal or subtenon injection of ophthalmic corticosteroid.
  • •17. Underwent within six months prior to baseline any other intraocular surgery (e.g., cataract surgery).
  • •18. Underwent within 12 months prior to baseline: refractive surgery, filtering surgery for IOP reduction.
  • •19. Amblyopia - only one sighted eye.
  • •20. Clinically significant or progressive retinal disease (e.g., retinal degeneration, diabetic retinopathy, retinal detachment) in either eye.
  • •21. Any abnormality preventing reliable applanation tonometry.
  • •22. History or presence of significant alcoholism or drug abuse in the past one year.
  • •23. Active smoker at the time of screening.
  • •24. Active or prior severe, unstable, or uncontrolled cardiovascular, cerebrovascular, hepatic, or renal disease that would prevent safe administration of topical a-adrenergic agonists or carbonic anhydrase inhibitors, according to the investigator.
  • •25. Any form of glaucoma other than open-angle glaucoma.
  • •26. Therapy with an investigational agent within the past 30 days from screening.
  • •27. Clinically significant hematologic and/or biochemical abnormalities based on laboratory testing as judged by investigator.
  • •28. Patients who are at risk of visual field or visual acuity worsen

研究者

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