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

Ocular Hypertension Clinical Trial

Official title:

Non Interventional Study in Patients With Open Angle Glaucoma and/or Ocular Hypertension Treated With XALATAN® (Latanoprost) as First-Line Monotherapy and as Second-Line Monotherapy After Beta-Blockers Therapy Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00486252
• Other study ID #: A6111138
• Status: Completed
• Start date: June 2007
• Est. completion date: January 2008

Study information

• Verified date: November 2009
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 996
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Glaucoma,Open-Angle
• Hypertension
• Ocular Hypertension

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Intraocular Presssure (IOP): Baseline to Month 1	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 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.	Baseline, Month 1
Primary	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.	Baseline, Month 3
Secondary	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.	Month 1, Month 3
Secondary	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).	Month 1, Month 3

External Links

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