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

History of Changes

Tracking Information

First Received Date ^ICMJE

September 29, 2005

Last Updated Date

October 14, 2008

Start Date ^ICMJE

September 2005

Primary Completion Date

October 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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

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 ]

Original Secondary Outcome Measures ^ICMJE

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 Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Arm (s)

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.

* 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

Enrollment ^ICMJE

396

Completion Date

October 2007

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,

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00230763

Other Study ID Numbers ^ICMJE

A6641040

Has Data Monitoring Committee

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

Information Provided By

Pfizer

Verification Date

October 2008

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

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