Health Condition 1: H401- Open-angle glaucoma
Conditions
Interventions
Intervention1: Nanodropper: Study participants will be instilled Nanodropper-mediated microdrop of 0.5% timolol maleate
Frequency : One drop only
Duration : Single dose
Control Intervention1: Standard
Sponsors
Nanodropper Inc
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with a recent diagnosis of primary open angle glaucoma (POAG) or ocular hypertension (OHT) and are not taking any ophthalmic medications for whom 0.5% timolol maleate would be prescribed as a first-line treatment 2. Participants must have corrected Snellen visual acuity of 6/60 or better in each eye 3. The baseline IOP should be between 21 and 35 mmHg as assessed by Goldmann applanation tonometry
Exclusion criteria
Exclusion criteria: 1. A recent history (within the past 6 months) of ocular trauma, infection, or uveitis 2. Baseline IOP of 3. Baseline IOP of > 35 mmHg 4. History of cardiovascular, pulmonary, cerebrovascular, or chronic renal disease 5. History of borderline or uncontrolled systemic arterial hypertension 6. Use of any systemic α-agonist or β-blocker within 30 days of study commencement 7. History of receiving general anesthesia within the previous 30 days 8. Pregnant women and nursing mothers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The mean change in intraocular pressure (IOP) from baseline The mean change in resting heart rate (HR) and blood pressure (BP) from baseline IOP, resting HR, and BP measurements will be repeated at 1 hour, 2 hours, 5 hours, and 8 hours after drop administration in either groups Timepoint: The mean change in intraocular pressure (IOP) from baseline The mean change in resting heart rate (HR) and blood pressure (BP) from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| NilTimepoint: Nil | — |
Countries
India
Contacts
Public ContactAnnamalai O
Aravind Eye Hospital, Pondicherry
Outcome results
None listed