A Study to Assess the Efficacy of 3 Months of Latanoprost Treatment in Reducing the Intraocular Pressure in Patients With Ocular Hypertension or Open-Angle Glaucoma - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00647101

Purpose

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.

Condition	Intervention	Phase
Glaucoma, Open-Angle Ocular Hypertension	Drug: Latanoprost	Phase IV

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

Drug Information available for: Latanoprost

U.S. FDA Resources

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

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change in IOP after 3 months of treatment in absolute values (mmHg) compared to baseline IOP [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in IOP after 3 months of treatment in relative values (percentage of decrease) compared to baseline IOP [ Time Frame: 3 months ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as safety issue: No ]
Occurrence of adverse events on latanoprost, local tolerability analysis by clinical exam [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment:	600
Study Start Date:	December 2003
Study Completion Date:	February 2005

Arms	Assigned Interventions
Latanoprost group: Experimental	Drug: Latanoprost Latanoprost 0.005% drops: 1 drop in the diseased eye(s) in the evening for 3 months

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00647101

Show 179 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6111002, X-FIL
Study First Received:	March 26, 2008
Last Updated:	March 28, 2008
ClinicalTrials.gov Identifier:	NCT00647101
Health Authority:	France: Ministry of Health

Study placed in the following topic categories:

Glaucoma
Eye Diseases
Glaucoma, Open-Angle
Vascular Diseases

Latanoprost
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:

Therapeutic Uses
Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009