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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cardiovascular Diseases
Eye Diseases
Vascular Diseases
Latanoprost
Antihypertensive Agents
Cardiovascular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014