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

Last updated on May 12, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Agen, , 47000 France
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Primary Open Angle (POAG) Glaucoma, Ocular Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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 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,

NCT00230763
Pfizer
Completed
Determination Of Predictive Factors Allowing To An Additional 10% Reduction Of Intra-Ocular Pressure

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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
Intervention Model: Single Group Assignment
Masking: None (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,
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00230763
A6641040
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

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