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Trial record 1 of 1 for:    NCT00230763
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Determination Of Predictive Factors Allowing To An Additional 10% Reduction Of Intra-Ocular Pressure (PREDICOM)

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ClinicalTrials.gov Identifier: NCT00230763
Recruitment Status : Completed
First Posted : October 3, 2005
Last Update Posted : March 5, 2015
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE September 29, 2005
First Posted Date  ICMJE October 3, 2005
Last Update Posted Date March 5, 2015
Study Start Date  ICMJE September 2005
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 19, 2008)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 29, 2005)
A positive response defined as an additional IOP reduction over 10% after 12 weeks of treatment in the intent to treat (ITT) population.
Change History Complete list of historical versions of study NCT00230763 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2005)
  • Absolute and relative IOP change after 4 and 12 weeks of treatment
  • Percentage of patients achieving a target IOP value: under 18 mmHg and under 16 mmHg after 12 weeks of treatment,
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Determination Of Predictive Factors Allowing To An Additional 10% Reduction Of Intra-Ocular Pressure
Official Title  ICMJE 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
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Glaucoma, Primary Open Angle (POAG)
  • Ocular Hypertension
Intervention  ICMJE
  • Procedure: GSS questionnaire
    D0, D30 and D84
  • Procedure: IOP
    D0, D30 and D84
  • Drug: LATANOPROST 0.005% / TIMOLOL 0.5% FIXED COMBINATION
    in the evening during 84 days
    Other Name: XALACOM
  • Procedure: Visual acuity
    D0 and D84
Study Arms  ICMJE
  • Experimental: Active
    Intervention: Drug: LATANOPROST 0.005% / TIMOLOL 0.5% FIXED COMBINATION
  • Procedure
    Interventions:
    • Procedure: GSS questionnaire
    • Procedure: IOP
    • Procedure: Visual acuity
Publications * Sellem E, Rouland JF, Baudouin C, Bron A, Denis P, Nordmann JP, Renard JP. Predictors of additional intraocular pressure reduction in patients changed to latanoprost/timolol fixed combination. BMC Ophthalmol. 2010 Mar 26;10:10. doi: 10.1186/1471-2415-10-10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 19, 2008)
396
Original Enrollment  ICMJE
 (submitted: September 29, 2005)
770
Actual Study Completion Date  ICMJE October 2007
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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,
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00230763
Other Study ID Numbers  ICMJE A6641040
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP