Official Title: “Open Multicenter Study on the Efficacy of Xalatan at 3 Months as First-Line Therapy in Naive Patients With Ocular Hypertension (OH) or Open Angle Glaucoma (OAG), Based on Initial Intraocular Pressure (IOP): 20 mmHg Less Than or Equal to IOP Less Than 24 mmHg, IOP Greater Than or Equal to 24 mmHg”

The purpose of this study is to evaluate the effect of latanoprost on intraocular pressure reduction in patients with ocular hypertension or open-angle glaucoma.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Latanoprost
  • Latanoprost 0.005% drops: 1 drop in the diseased eye(s) in the evening for 3 months

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Latanoprost group

Primary Measures

• Change in IOP after 3 months of treatment in absolute values (mmHg) compared to baseline IOP
  • Time Frame: 3 months
    Safety Issue?: No

Secondary Measures

• Change in IOP after 3 months of treatment in relative values (percentage of decrease) compared to baseline IOP
  • Time Frame: 3 months
    Safety Issue?: No
• Proportion of patients after 3 months of treatment with a relative reduction in IOP of greater than or equal to 30%, and greater than or equal to 10%
  • Time Frame: 3 months
    Safety Issue?: No
• Change in IOP after 1 month of treatment in absolute (mmHg) and relative values (percentage of decrease) relative to baseline IOP
  • Time Frame: 1 month
    Safety Issue?: No
• Proportion of patients after 1 month of treatment with a relative reduction in IOP of greater than or equal to 30%, and greater than or equal to 10%
  • Time Frame: 1 month
    Safety Issue?: No
• Proportion of patients after 3 months of treatment achieving the following target IOP values: IOP less than or equal to 21 mmHg, IOP less than or equal to 18 mmHg, IOP less than or equal to 15 mmHg
  • Time Frame: 3 months
    Safety Issue?: No
• Proportion of patients after 1 month of treatment achieving the following target IOP values: IOP less than or equal to 21 mmHg, IOP less than or equal to 18 mmHg, IOP less than or equal to 15 mmHg
  • Time Frame: 1 month
    Safety Issue?: No
• Occurrence of adverse events on latanoprost, local tolerability analysis by clinical exam
  • Time Frame: 3 months
    Safety Issue?: Yes

Inclusion Criteria:

• A patient with an IOP greater than or equal to 20 mmHg related to unilateral or bilateral OH or OAG (primary open angle glaucoma, pseudo-exfoliative glaucoma, and pigmentary glaucoma), after a visual field exam
• Naive patients (i.e. never having been treated) and requiring treatment initiation

Exclusion Criteria:

• A patient with OH or OAG currently on treatment
• A patient with OH or OAG previously treated (regardless of the date treatment was discontinued)
• A patient with traumatic, inflammatory, or neovascular glaucoma

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00647101

Study ID Number: A6111002

ClinicalTrials.gov Identifier: NCT00647101

Health Authority: France: Ministry of Health

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