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Determination Of Predictive Factors Allowing To An Additional 10% Reduction Of Intra-Ocular Pressure (PREDICOM)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00230763
First Posted: October 3, 2005
Last Update Posted: March 5, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  Purpose
To determine the predictive factors of a positive response to latanoprost 0.005% / timolol 0.5% fixed combination (defined as a 10% IOP reduction from baseline), after 12 weeks of treatment (age, sex, ethnic origin, patient's medical history, family history of OAG or OHT, concomitant systemic treatment with beta-blockers, etiology, IOP at baseline, corneal thickness, compliance, and adverse events).

Condition Intervention Phase
Glaucoma, Primary Open Angle (POAG) Ocular Hypertension Procedure: GSS questionnaire Procedure: IOP Drug: LATANOPROST 0.005% / TIMOLOL 0.5% FIXED COMBINATION Procedure: Visual acuity Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Determination Of Predictive Factors Allowing To An Additional 10% Reduction Of Intra-Ocular Pressure After A 12-Week Treatment With Latanoprost 0.005% / Timolol 0.5% Fixed Combination (Xalacom) In Previously Treated Patients With Open Angle Glaucoma Or Ocular Hypertension

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • A positive response defined as an additional IOP reduction over 10% after 12 weeks of treatment in the intent to treat (ITT) population. [ Time Frame: after 12 weeks of treatment ]

Secondary Outcome Measures:
  • Absolute and relative IOP change after 4 and 12 weeks of treatment [ Time Frame: week 4 and 12 ]
  • Percentage of patients achieving a target IOP value: under 18 mmHg and under 16 mmHg after 12 weeks of treatment, [ Time Frame: week 12 ]

Enrollment: 396
Study Start Date: September 2005
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Drug: LATANOPROST 0.005% / TIMOLOL 0.5% FIXED COMBINATION
in the evening during 84 days
Other Name: XALACOM
Procedure Procedure: GSS questionnaire
D0, D30 and D84
Procedure: IOP
D0, D30 and D84
Procedure: Visual acuity
D0 and D84

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients,
  • Aged > than equal to 18 years,
  • Patient presenting with an OHT or OAG with an IOP � 21 mmHg,
  • Patient currently treated with ophthalmic beta-blockers monotherapy and requiring a change of the ophthalmic medication due to insufficient response to treatment,

Exclusion Criteria:

  • Patient currently treated by or having received within the last month any ophthalmic hypotensive agent other than a beta-blocker,
  • Patient presenting any contraindication to latanoprost or timolol,
  • Patient with history of asthma, obstructive broncho-pneumopathy, sinusal bradycardia (pulse rate < 60 bpm), auriculo-ventricular block, cardiac insufficiency, Raynaud disease or any other condition that would preclude the patient from taking the prescribed medication,
  • Patient with known intolerance to benzalkonium chloride or any excipient contained in the trial treatment,
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00230763


  Show 102 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00230763     History of Changes
Other Study ID Numbers: A6641040
First Submitted: September 29, 2005
First Posted: October 3, 2005
Last Update Posted: March 5, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Hypertension
Glaucoma
Ocular Hypertension
Glaucoma, Open-Angle
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Timolol
Latanoprost
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents