Health Condition 1: H00-H59- Diseases of the eye and adnexa
Conditions
Interventions
Intervention1: Brinzolamide and Timolol Ophthalmic Suspension: One drop of Brinzolamide and Timolol Ophthalmic Suspension (1% w/v + 0.5% w/v) should be instilled into conjunctival sac of the affected
Sponsors
Sun Pharma Laboratories Limited (SPLL)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either gender aged >= 18 years who are willing to provide written informed consent 2. Patients diagnosed with Primary Openâ??angle glaucoma or Ocular hypertension 3. Patients who are on mono-therapy of either carbonic anhydrase inhibitors (CAIs) or Beta-blockers or any other IOP-lowering therapy and not adequately controlled 4. Women of childbearing potential must have a negative urine pregnancy test before study entry and agree to use highly effective methods of contraception to prevent pregnancy from study entry till at least two weeks after the last dose of the study medication 5. Male patients must have had a successful vasectomy or they and their female partners must meet the criteria above
Exclusion criteria
Exclusion criteria: 1. Patients with a history of allergic hypersensitivity to oral or topical Carbonic Anhydrase Inhibitors, Beta -blockers, sulfonamide drugs, or any components of these medications 2. Patients with acute or chronic conjunctivitis 3. Patients with reactive airway disease including bronchial asthma or a history of bronchial asthma, or severe chronic obstructive pulmonary disease 4. Patients with known/history of sinus bradycardia, sick sinus syndrome, sino-atrial block, second or third degree atrioventricular block not controlled with pace-maker, overt cardiac failure, and cardiogenic shock 5. Patients with uncontrolled hypertension, dry eye syndrome, diabetic retinopathy, hyperchloraemic acidosis and uncontrolled diabetes 6. Patients with severe allergic rhinitis 7. Patients using intraocular corticosteroid implant 8. Patients using contact lenses within 1 week prior to enrolment 9. Patients using the following medications within two weeks prior to baseline of: 1) topical ophthalmic corticosteroid; 2) topical corticosteroid; 3) systemic corticosteroid, or 4) high dose salicylate therapy 10. Patients using intravitreal or subtenon injection of ophthalmic corticosteroid within 6 months prior to enrolment 11. Patients who are anticipated the need to initiate or modify medication that is known to affect IOP during the study period 12. Patients with severe renal impairment 13. Patients undergone intraocular surgery or laser surgery within the past 3 months 14. Patients currently using any systemic corticosteroid, or is having had therapy with any investigational agent within past 30 days 15. Patients with history of hematologic disorders other than mild anemia 16. Patients with history of non-compliance to medical regimens or those patients unwilling to comply with the study protocol 17. Patients with history of or currently having any of the severe/serious ocular condition or clinically significant medical conditions, such as cardiovascular, respiratory, renal, hepatic, endocrine, or gastrointestinal disease 18. Patients with history of or known case of HIV-AIDS, hepatitis B (Hep B), and hepatitis C (Hep C) 19. Participation in other studies involving investigational drugs or surgeries within the last 30 days or investigational biologics within the last 6 months prior to screening 20. Pregnant or lactating women and women of childbearing potential who are not using contraceptives 21. Investigator, study personnel, Sponsor representatives and their first degree relatives
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with treatment-emergent adverse events (TEAEs)Timepoint: Throughout the study period | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in 0-hour pre-dose IOPTimepoint: Day 28, 56, and 84;Change from baseline in 2-hour post-dose IOPTimepoint: Day 28, 56, and 84 | — |
Countries
India
Contacts
Public ContactVibhawari Waghanna
Sun Pharma Laboratories Limited
Outcome results
None listed