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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00647101
First received: March 26, 2008
Last updated: March 28, 2008
Last verified: March 2008
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
Experimental: Latanoprost group 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 176 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00647101     History of Changes
Other Study ID Numbers: A6111002, X-FIL
Study First Received: March 26, 2008
Last Updated: March 28, 2008
Health Authority: France: Ministry of Health

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Latanoprost
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014