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

Completed

• Conditions: Glaucoma,Open-Angle; Ocular Hypertension
• Interventions: Other: Observational

• Registration Number: NCT00486252
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-06-12
• Study First Submitted QC: 2007-06-12
• Study First Posted: 2007-06-14
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Results First Submitted: 2009-03-31
• Results First Submitted QC: 2009-05-27
• Results First Posted: 2009-07-16
• Status Verified: 2009-11
• Last Update Submitted: 2021-02-01
• Last Update Posted: 2021-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 996

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
This is N/A due to the above description.	Observational	This is N/A due to the above description.

Primary Outcome Measures

Name	Time	Method
Change in Intraocular Pressure (IOP): Baseline to Month 3	Baseline, 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.

Secondary Outcome Measures

Name	Time	Method
Percentage Change in Intraocular Pressure (IOP)	Month 1, Month 3	Percentage change in IOP calculated as 100 times (IOP at Observation minus IOP at Baseline) divided by IOP at Baseline.
Categorized Percentage Change in Intraocular Pressure (IOP)	Month 1, Month 3	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).