Health Condition 1: H401- Open-angle glaucoma
Conditions
Interventions
Intervention1: FDC Brinzolamide 1% w/v plus Brimonidine 0.1% w/v
IP Ophthalmic Suspension: The recommended dosage is one drop of FDC of Brinzolamide 1% w/v plus Brimonidine 0.1% w/v IP Ophthalmic Sus
Sponsors
Akums Drugs Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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; �±- agonists and �±/�² agonists for 14 days; �²-antagonists and prostaglandin analogues for 28 days. 3. Patients with 0-hour IOP of â�¥ 24 - â�¤ 36 mm Hg and 2-hour IOP of â�¥ 21 - â�¤ 36 mm of affected eye(s). 4. Patients with mean IOP 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. OR Postmenopausal for at least 1 year. OR 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 obtained. 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.
Exclusion criteria
Exclusion criteria: 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 3. Patients with cup-to disc ratio > 0.80 (horizontal or vertical measurement) in either eye. 4. 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. 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 � 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 � 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 � 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 visit. 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 visit. 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 drugs. 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 the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in mean IOP from baseline.Timepoint: Baseline, week 4, week 8 and week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the mean value of Morisky medication adherence scale between two groups.Timepoint: 12 weeks;Mean change in 0-hour time point IOP from baseline.Timepoint: Baseline, week 4, week 8 and week 12;Mean change in 2-hour time point IOP from baseline.Timepoint: Baseline, week 4, week 8 and week 12;Percentage of patients with target IOP (ââ?°Â¤ 21mmHg)Timepoint: 12 weeks;Proportion of patients with incidence of at least one adverse event.Timepoint: Week 12 | — |
Countries
India
Contacts
Public ContactDr Aditi Datta
Biosite Research Private Limited
Outcome results
None listed