Clinical results using Latanoprost 0.005% (Xalatan®) compared to Latanoprost 0.005% (Arulatan®) eye drops in patients with glaucoma or ocular hypertensio

Not Applicable

• Conditions: Glaucoma open angleOcular hypertensionGlaucoma suspect

• Registration Number: RBR-82q4yf5
• Lead Sponsor: IPEPO - Instituto Paulista de Estudos e PEsquisas em Oftalmologia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-01-07
• Study Start: 2021-09-09
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Intervention
• Study Design: Not specified