Glaucoma open angle Ocular hypertension Glaucoma suspect
Conditions
Interventions
Experimental Group: 20 patients (40 eyes) diagnosed with primary open-angle glaucoma or ocular hypertension. After washout period, they will start using 0.005% Latanoprost eye drops (Arulatan®) 1x / d
Sponsors
IPEPO - Instituto Paulista de Estudos e PEsquisas em Oftalmologia
IPEPO - Instituto Paulista de Estudos e PEsquisas em Oftalmologia
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients 18 years of age or older, both gender and of any race, diagnosed with open-angle primary glaucoma or ocular hypertension. Patients should be able to understand and sign the informed consent that has been approved by a Research Ethics Committee. After a 28-day washout, the patient should have intraocular pressure between 21mmHg and 36mmHg, to confirm eligibility
Exclusion criteria
Exclusion criteria: 1. Fertile women are excluded from participating in the study if they meet any of the following conditions: currently pregnant or, present positive results in the urine pregnancy test at the Screening Visit or, plan to become pregnant during the study period or, are breastfeeding. Patients with severe central visual field loss. Severe central visual field loss is defined as a sensitivity less than or equal to 10 dB in at least 2 of the 4 visual field test points closest to the point of attachment. Patients who can not safely discontinue use of all ocular medications for IOP reduction for a period of 28 days ± 1 day prior to the Randomization Visit. Chronic, recurrent or severe inflammatory eye disease (ie, scleritis, uveitis, herpetic keratitis). Eye trauma in the last 6 months. Eye infection or eye inflammation in the last 3 months. Clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy or retinal detachment. Intraocular surgery in the last 6 months. Laser eye surgery in the last 3 months. Any abnormality that prevents reliably flattening tonometry. Any other condition including serious illness that would make the patient, in the Investigator's opinion, unsuitable for the study. Therapy with another investigating agent within 30 days prior to the Screening Visit. Use of any additional topical or systemic ocular hypotensive medication during the study. Concomitant use of glucocorticoids given by any route.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the decrease of the mean daytime Intraocular Pressure (IOP) at Month 3, compared to baseline, by applanation tonometry | — |
Secondary
| Measure | Time frame |
|---|---|
| • Evaluate the deacrease of Mean Intraocular Pressure change from baseline (Week 2, Week 6 and Month 3), by applanation tonometry | — |
Countries
Brazil
Contacts
Public ContactRodrigo Brant
IPEPO - Instituto Paulista de Estudos e PEsquisas em Oftalmologia
Outcome results
None listed