CTRI/2022/04/042021招募中3 期
A Multi-Center,Open-Label, Randomized,Active Controlled, Comparative,Parallel-Group, Phase III Clinical Study to Evaluate the efficacy and safety of FDC of Brinzolamide 1% w/v plus Brimonidine 0.1% w/v IP Ophthalmic Suspension versus Brinzolamide Ophthalmic Suspension 1% w/v plus Brimonidine Tartrate Ophthalmic solution 0.1% w/v in patients with Primary open-angle glaucoma or ocular hypertension.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
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 non-pregnant, non-lactating female subjects between 18 to 75 years of age
- •(both inclusive).
- •2. Patients diagnosed with Open-angle glaucoma or ocular hypertension who were
- •insufficiently controlled on monotherapy or being treated with multiple IOP-lowering
- •medications.
- •Note: Patients will undergo washout period as follows: miotics and oral or topical
- •carbonic anhydrase for 4 days; Ã?±- agonists and Ã?±/Ã?² agonists for 14 days; Ã?²-antagonists
- •and prostaglandin analogues for 28 days.
- •3. Patients with 0-hour IOP of ââ?°Â¥ 24 - ââ?°Â¤ 36 mm Hg and 2-hour IOP of ââ?°Â¥ 21 - ââ?°Â¤ 36 mm of
- •affected eye(s).
- •4. Patients with mean IOP ââ?°Â¤ 36 mm Hg in both eyes at all time points.
- •5. Patients with best corrected visual acuity equivalent to 20/200 or better in each eye.
- •6. Female Patients, of child-bearing potential practicing an acceptable method of birth
- •control such as sexual abstinence, intrauterine device IUD, birth control pills, a double-
- •barrier method, transdermal, injection or implants, non-hormonal or hormonal,
- •condom plus spermicide, diaphragm plus spermicide, or vaginal spermicidal
- •suppository; for the duration of the study as judged by the investigator(s)/study
- •physician and agree to follow the same should be used during treatment.
- •Postmenopausal for at least 1 year.
- •Surgically sterile (bilateral tubal ligation/bilateral oophorectomy/ hysterectomy has
- •been performed on the Subject).
- •7. Patients who are able to understand and give voluntary, written informed consent to
- •participate in this clinical investigation and from whom written consent has been
- •8. Patients shall be willing and able to understand and comply with the requirements of
- •the study, administer the study medication as instructed, return for the required treatment period visits, comply with therapy prohibitions and be able to complete the study.
排除标准
- •1. Documented history of hypersensitivity to either of the study medications or any of the
- •ingredients of the formulation.
- •2. Patients with Schaffer angle grade < 2 in either eye (as measured by gonioscopy).
- •3. Patients with cup-to disc ratio > 0.80 (horizontal or vertical measurement) in either
- •4. Patients with severe central visual field loss (i.e., sensitivity ââ?°Â¤ 10 dB in ââ?°Â¥ 2 of the 4
- •visual field test points closest to the point of fixation) in either eye.
- •5. Patients with history of chronic, recurrent, or current severe inflammatory eye disease
- •(i.e., scleritis, uveitis, herpes keratitis) in either eye.
- •6. Patients with documented history of ocular trauma ââ?°Â¤ 6 months before the study.
- •7. Patients with documented history of clinically significant or progressive retinal disease
- •(e.g., retinal degeneration, diabetic retinopathy, retinal detachment) in either eye.
- •8. Patients with documented history of intraocular surgery ââ?°Â¤ 6 months before the study.
- •9. Patients with documented history of cataract or corneal ulcer.
- •10. Patients who are unable to safely discontinue IOP-lowering ocular medications.
- •11. Patients with documented history of ocular laser surgery ââ?°Â¤ 3 months before the study.
- •12. Patients with one eye.
- •13. Patients with any abnormality preventing reliable applanation tonometry.
- •14. Patients with severe illness or other condition that would make the patient unsuitable
- •for the study, as per investigator discretion.
- •15. Patients with active or prior severe, unstable, or uncontrolled cardiovascular,
- •cerebrovascular, hepatic, or renal disease that would prevent safe administration of
- •topical alpha-adrenergic agonists or carbonic anhydrase inhibitors, as per investigator
- •discretion.
- •16. Patients with use of topical ophthalmic corticosteroid or topical corticosteroid within
- •two weeks prior to baseline visit.
- •17. Patients with use of intraocular corticosteroid implant at any time prior to baseline
- •18. Patients with use of systemic corticosteroids, high-dose salicylate therapy, monoamine
- •oxidase inhibitors therapy, any antidepressant which affects noradrenergic
- •transmission (eg, tricyclic antidepressants, mianserin) and adrenergic-augmenting
- •psychotropic drug (eg, desipramine, amitriptyline) within one month prior to baseline
- •19. Patients with clinically significant laboratory abnormalities at the time of screening.
- •20. Changes in systemic medication within 30 days prior to screening that could have a
- •substantial impact on IOP, or anticipated changes during the study.
- •21. Currently taking prohibited concomitant medications(s) listed and inability/unwillingness to discontinue them for the entire study period.
- •22. Patients who are known seropositive cases of HIV, Hepatitis B or Hepatitis C.
- •23. Patients who have a recent history or who are currently known to abuse alcohol or
- •24. Patients who have been treated with an investigational drug or investigational device
- •within a period of 4 weeks prior to study entry.
- •25. Female Patients who are pregnant or lactating or planning to become pregnant during
研究者
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