Health Condition 1: H401- Open-angle glaucoma
Conditions
Interventions
Intervention1: Drugs: Group N will receive Netarsudil ophthalmic solution 0.02% (eye drops) of the same brand.
Group B will receive Bimatoprost ophthalmic solution 0.01% (eye drops) of same brand.
Co
Sponsors
KIMSBangalore
Eligibility
Inclusion criteria
Inclusion criteria: Subjects aged more than or equal to 40 years of age of either sex. Individuals diagnosed with Primary open angle glaucoma (POAG) in both the eyes or at least in one eye. Treatment naïve subjects having intraocular pressure (IOP) of more than 21mmHg and lesser than 32 mmHg as per Goldmann applanation tonometry in both the eyes or at least in one eye.
Exclusion criteria
Exclusion criteria: Subjects with Pseudo exfoliation or pigment dispersion glaucoma. Subjects with history of angle closure or narrow iridocorneal angles which includes previous peripheral iridotomy. Subjects who had previous intraocular glaucoma or any refractive or ocular surgery or who had taken non-refractive laser treatment in the last three months before screening. Subjects who currently have an inflammation (uveitis, keratitis etc.) or who have an ocular infection in either eye. Subjects who have had an ocular trauma in the past six months before screening. Participants having any abnormality in either eye, thereby preventing reliable applanation tonometry. Subjects having hypersensitivity to any of the components of the drugs being studied. Subjects with history of Chronic Obstructive Pulmonary disease, unstable or uncontrolled cardiovascular disease. Subjects on topical or systemic corticosteroids. Pregnant and lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in the mean IOP from baseline in the study eye at the end of 3rd week in both the groups. =30% reduction in mean IOP from the baseline at the end of 3rd week is considered to be statistically significant.Timepoint: At the end of 3rd week. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Reduction in the mean IOP from baseline in the study eye at the end of 3rd month. 2. BCVA and objective findings of bio microscopic examinations and vertical cup–disc ratio measurements at the end of 3rd week and 3rd month from the baseline visit. 3. Need and timing of administration of the rescue medication, during the study period. Timepoint: At the end of 3rd week. At the end of 3rd month. | — |
Countries
India
Contacts
Public ContactN HAMSINI
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES, BENGALURU
Outcome results
None listed