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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:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00230763
First received: September 29, 2005
Last updated: October 14, 2008
Last verified: October 2008

September 29, 2005
October 14, 2008
September 2005
October 2007   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
A positive response defined as an additional IOP reduction over 10% after 12 weeks of treatment in the intent to treat (ITT) population.
Complete list of historical versions of study NCT00230763 on ClinicalTrials.gov Archive Site
  • Absolute and relative IOP change after 4 and 12 weeks of treatment [ Time Frame: week 4 and 12 ] [ Designated as safety issue: No ]
  • Percentage of patients achieving a target IOP value: under 18 mmHg and under 16 mmHg after 12 weeks of treatment, [ Time Frame: week 12 ] [ Designated as safety issue: No ]
  • 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,
Not Provided
Not Provided
 
Determination Of Predictive Factors Allowing To An Additional 10% Reduction Of Intra-Ocular Pressure
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

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).

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Glaucoma, Primary Open Angle (POAG)
  • Ocular Hypertension
  • 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
  • Experimental: Active
    Intervention: Drug: LATANOPROST 0.005% / TIMOLOL 0.5% FIXED COMBINATION
  • Procedure
    Interventions:
    • Procedure: GSS questionnaire
    • Procedure: IOP
    • Procedure: Visual acuity
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.
 
Completed
396
October 2007
October 2007   (final data collection date for primary outcome measure)

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,
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00230763
A6641040
No
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2008

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