Skip to main content
OpenTrials
Completed

NCT Number: NCT00230763

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Glaucoma, Primary Open Angle (POAG) Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Agen, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

GSS questionnaire

Procedure

D0, D30 and D84

IOP

Procedure

D0, D30 and D84

LATANOPROST 0.005% / TIMOLOL 0.5% FIXED COMBINATION

Drug

in the evening during 84 days

Other names: XALACOM

Visual acuity

Procedure

D0 and D84

Primary outcomes

  1. 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 outcomes

  1. Absolute and relative IOP change after 4 and 12 weeks of treatment

    Time frame: week 4 and 12

  2. Percentage of patients achieving a target IOP value: under 18 mmHg and under 16 mmHg after 12 weeks of treatment,

    Time frame: week 12

Sponsors and collaborators

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Industry

Registry information

Official study 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

Acronym: PREDICOM

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Oct 3, 2005
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.