Non Interventional Study in Patients With Open Angle Glaucoma and/or Ocular Hypertension Treated With XALATAN®

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.996 enrolled

Overview

The primary objective is to evaluate the Intraocular pressure reducing effect of Xalatan over 3 months. The secondary objective is to study the other efficacy parameters during treatment for 3 months

Study Type

OBSERVATIONAL

Enrollment

996

Conditions

Glaucoma,Open-Angle Ocular Hypertension

Interventions

ObservationalOTHER

This is a non-interventional study. Subgroups of naïve patients and patients with previous failure to beta-blockers therapy were analyzed.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Unilateral or bilateral open angle glaucoma or ocular hypertension (IOP (Intraocular Pressure) ≥ 21 mmHg at diagnosis). * Naive patients (no prior anti-glaucoma pharmacological or surgical treatment) and patients with beta-blockers therapy failure * Visual acuity (best corrected) equal to or better than 6/6 Exclusion Criteria: * closed/barely open anterior chamber angle or history of acute angle closure glaucoma. * history of any antiglaucoma surgical treatment (Argon Laser Trabeculoplasty and/or any ocular filtering surgical intervention). * ocular surgery (on the globe of the eye only), or inflammation/infection within 3 months prior to baseline visit. (Applies to both fellow and study eyes.) * other abnormal ocular conditions or symptoms preventing the patient from entering the study, in the investigator's clinical judgement.

Outcomes

Primary Outcomes

Change in Intraocular Pressure (IOP): Baseline to Month 3

Change: IOP at observation minus IOP at baseline. IOP was measured with the non-contact or Goldmann tonometer for a given subject. Three measurements were performed in each eye alternating between the eyes, starting with the right eye. The mean of the 3 measurements was used and if both eyes were study eyes, the mean of the 2 eyes was used.

Time frame: Baseline, Month 3

Secondary Outcomes

Percentage Change in Intraocular Pressure (IOP)

Percentage change in IOP calculated as 100 times (IOP at Observation minus IOP at Baseline) divided by IOP at Baseline.

Time frame: Month 1, Month 3

Categorized Percentage Change in Intraocular Pressure (IOP)

Percentage change=100 times (IOP at observation minus IOP at Baseline) divided by IOP at Baseline. Percentage change in each patient assigned to the following: Increase or no change in IOP (percentage change greater than or equal to 0); Percentage reduction of up to 20% (-20 less than or equal to percentage change \< 0); Percentage reduction greater than 20% (percentage change \< -20).

Time frame: Month 1, Month 3

Data from ClinicalTrials.gov

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