Health Condition 1: null- diagnosed with OHT or OAG in one or both eyes Health Condition 2: H401- Open-angle glaucoma
Conditions
Interventions
Intervention1: Brimonidine tartrate ophthalmic suspension 0.35%: Topical administration Once daily for 7 days in affected eyes
Control Intervention1: Alphagan® P 0.1% ophthalmic suspension: Topical a
Sponsors
Sun Pharma Advanced Research Company Limited
Eligibility
Inclusion criteria
Inclusion criteria: -Willing and able to give written informed consent. -diagnosis of OHG or OAG -Unmedicated IOP >= 22 mmHg and both eyes -Women of child bearing potential practicing an acceptable method of birth control
Exclusion criteria
Exclusion criteria: -Women who are Pregnant nursing or planning a pregnancy or who were of childbearing potential and not using reliable method of contraception -Known lack of ocular hypotensive response to topical ophthalmic alpha adrenergic receptor agonists in the opinion of the Investigator -Severe or serious hypersensitivity to alpha-adrenergic agonist drugs -Intraocular conventional surgery in any eye within the past six months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and pharmacokineticsTimepoint: 7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: Mean IOPTimepoint: 7 days | — |
Countries
India
Contacts
Public ContactDr Mudgal Kothekar MD
Sun Pharma Advanced Research Company Limited
Outcome results
None listed