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
- 入组人数
- 216
- 试验地点
- 9
- 主要终点
- Change in mean IOP from baseline.
研究概览
简要总结
This is a Phase III, open label, randomized, multicenter, active controlled, parallel-group, two armcomparative study. The study will be conducted at approximately 12-15 number of centers in India,having qualified Investigators. The study will be initiated only after the receipt of regulatory andethics committee (EC) approval.
After the informed consent process, completion of all screening assessments and once all the inclusion/exclusion criteria are met, the eligible subjects shall be enrolled into the study. Demographics, Medical and surgical history shall be recorded during screening visit. Details of concomitant medications and adverse events if any shall be recorded during each visit. Physical examination (including general and systemic examinations) shall be done during screening and each successive visit. Vital signs shall be measured on each visit. Laboratory assessment and Urine Examination hall be performed on screening and week 12/ end of study visit. ECG will be performed at screening visit.
Ocular Assessments (visual acuity, slit-lamp examination, dilated fundus examination and gonioscopy) will be performed at each visit. Perimetry will be performed at screening and end of study visit. At randomization/baseline visit, subjects shall be randomly (open label) assigned in 1:1 fashion to one of the two treatment groups. ubjects shall be instructed to administer one drop of FDC of Brinzolamide 1% w/v plus Brimonidine 0.1% w/v IP Ophthalmic
Suspension of test drug twice daily (Preferably at Morning and Night) in the affected eyes or one drop of comparator drug (Brinzolamide Ophthalmic Suspension 1% w/v and Brimonidine Tartrate Ophthalmic solution 0.1% w/v individually in the affected eyes twice daily (Preferably at Morning and Night) with at least 10 minutes apart, for 12 weeks of treatment duration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and non-pregnant, non-lactating female subjects between 18 to 75 years of age (both inclusive).
- •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; α- agonists and α/β agonists for 14 days; β-antagonists and prostaglandin analogues for 28 days.
- •Patients with 0-hour IOP of ≥
- •â‰¤ 36 mm Hg and 2-hour IOP of ≥
- •â‰¤ 36 mm of affected eye(s).
- •Patients with mean IOP ≤ 36 mm Hg in both eyes at all time points.
- •Patients with best corrected visual acuity equivalent to 20/200 or better in each eye.
- •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. OR Postmenopausal for at least 1 year. OR Surgically sterile (bilateral tubal ligation/bilateral oophorectomy/ hysterectomy has been performed on the Subject).
- •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 obtained.
- •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
- •Documented history of hypersensitivity to either of the study medications or any of the ingredients of the formulation.
- •Patients with Schaffer angle grade < 2 in either eye (as measured by gonioscopy).
- •Patients with cup-to disc ratio > 0.80 (horizontal or vertical measurement) in either eye.
- •Patients with 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.
- •Patients with history of chronic, recurrent, or current severe inflammatory eye disease (i.e., scleritis, uveitis, herpes keratitis) in either eye.
- •Patients with documented history of ocular trauma ≤ 6 months before the study.
- •Patients with documented history of clinically significant or progressive retinal disease (e.g., retinal degeneration, diabetic retinopathy, retinal detachment) in either eye.
- •Patients with documented history of cataract or corneal ulcer.
- •Patients with documented history of ocular laser surgery ≤ 3 months before the study.
- •Patients with one eye.
- •Patients with any abnormality preventing reliable applanation tonometry.
- •Patients with severe illness or other condition that would make the patient unsuitable for the study, as per investigator discretion.
- •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.
- •Patients with use of topical ophthalmic corticosteroid or topical corticosteroid within two weeks prior to baseline visit.
- •Patients with use of intraocular corticosteroid implant at any time prior to baseline visit.
- •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 visit.
- •Patients with clinically significant laboratory abnormalities at the time of screening.
- •Changes in systemic medication within 30 days prior to screening that could have a substantial impact on IOP, or anticipated changes during the study.
- •Currently taking prohibited concomitant medications(s) listed and inability/unwillingness to discontinue them for the entire study period.
- •Patients who are known seropositive cases of HIV, Hepatitis B or Hepatitis C.
- •Patients who have a recent history or who are currently known to abuse alcohol or drugs.
- •Patients who have been treated with an investigational drug or investigational device within a period of 4 weeks prior to study entry.
- •Female Patients who are pregnant or lactating or planning to become pregnant during the study period.
- •Female Patients with positive urine pregnancy test at screening.
- •Suspected inability or unwillingness to comply with the protocol or other study procedures.
结局指标
主要结局
Change in mean IOP from baseline.
时间窗: Baseline, week 4, week 8 and week | 12
次要结局
- Mean change in 0-hour time point IOP from baseline.(Baseline, week 4,)
- Mean change in 2-hour time point IOP from baseline.(Baseline, week 4,)
- Percentage of patients with target IOP (≤ 21mmHg)(12 weeks)
- Change in the mean value of Morisky medication adherence scale between two groups.(12 weeks)
- Proportion of patients with incidence of at least one adverse event.(Week 12)