Ocular Hypertension Clinical Trial
— PREDICOMOfficial 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
Verified date | March 2015 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 396 |
Est. completion date | October 2007 |
Est. primary completion date | October 2007 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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, |
Country | Name | City | State |
---|---|---|---|
France | Pfizer Investigational Site | Agen | |
France | Pfizer Investigational Site | Amboise | |
France | Pfizer Investigational Site | Amiens | |
France | Pfizer Investigational Site | Andresy | |
France | Pfizer Investigational Site | Asnieres Sur Seine | |
France | Pfizer Investigational Site | Aubiere | |
France | Pfizer Investigational Site | Aurillac | |
France | Pfizer Investigational Site | Belfort | |
France | Pfizer Investigational Site | Besancon | |
France | Pfizer Investigational Site | Beziers | |
France | Pfizer Investigational Site | Bordeaux | |
France | Pfizer Investigational Site | Bourg en Bresse | |
France | Pfizer Investigational Site | Caen | |
France | Pfizer Investigational Site | Cannes | |
France | Pfizer Investigational Site | Castelsarrasin | |
France | Pfizer Investigational Site | Chalon Sur Saone | |
France | Pfizer Investigational Site | Chalons en Champagne | |
France | Pfizer Investigational Site | Chamalieres-Royat | |
France | Pfizer Investigational Site | Chambery | |
France | Pfizer Investigational Site | Chartres | |
France | Pfizer Investigational Site | Chassieu | |
France | Pfizer Investigational Site | Chateau Renault | |
France | Pfizer Investigational Site | Chateaudun | |
France | Pfizer Investigational Site | Clamart | |
France | Pfizer Investigational Site | Clermont Ferrand | |
France | Pfizer Investigational Site | Clermont-Ferrand | |
France | Pfizer Investigational Site | Colmar | |
France | Pfizer Investigational Site | Coulommiers | |
France | Pfizer Investigational Site | Dax | |
France | Pfizer Investigational Site | Etampes | |
France | Pfizer Investigational Site | Figeac | |
France | Pfizer Investigational Site | Frejus | |
France | Pfizer Investigational Site | Goussainville | |
France | Pfizer Investigational Site | Haguenau | |
France | Pfizer Investigational Site | Hyeres | |
France | Pfizer Investigational Site | Issy Les Moulineaux | |
France | Pfizer Investigational Site | Ivry Sur Seine | |
France | Pfizer Investigational Site | Jarny | |
France | Pfizer Investigational Site | La Fleche | |
France | Pfizer Investigational Site | Langon | |
France | Pfizer Investigational Site | Lannion | |
France | Pfizer Investigational Site | Le Mans | |
France | Pfizer Investigational Site | Le Quesnoy | |
France | Pfizer Investigational Site | Les Clayes Sous Bois | |
France | Pfizer Investigational Site | Les Lilas | |
France | Pfizer Investigational Site | Lille | |
France | Pfizer Investigational Site | Limoges | |
France | Pfizer Investigational Site | Luxeuil Les Bains | |
France | Pfizer Investigational Site | Lyon | |
France | Pfizer Investigational Site | Lyon | |
France | Pfizer Investigational Site | Lyon | |
France | Pfizer Investigational Site | Marseille | |
France | Pfizer Investigational Site | Marseille | |
France | Pfizer Investigational Site | Marseille | |
France | Pfizer Investigational Site | Marseille | |
France | Pfizer Investigational Site | Meaux | |
France | Pfizer Investigational Site | Meudon | |
France | Pfizer Investigational Site | Meyzieu | |
France | Pfizer Investigational Site | Montargis | |
France | Pfizer Investigational Site | Montbeliard | |
France | Pfizer Investigational Site | Montigny Le Bretonneux | |
France | Pfizer Investigational Site | Moulins | |
France | Pfizer Investigational Site | Mulhouse | |
France | Pfizer Investigational Site | Nantes | |
France | Pfizer Investigational Site | Nemours | |
France | Pfizer Investigational Site | Nice | |
France | Pfizer Investigational Site | Noeux Les Mines | |
France | Pfizer Investigational Site | Orleans | |
France | Pfizer Investigational Site | Orsay | |
France | Pfizer Investigational Site | Pantin | |
France | Pfizer Investigational Site | Paris | |
France | Pfizer Investigational Site | Paris | |
France | Pfizer Investigational Site | Paris | |
France | Pfizer Investigational Site | Paris | |
France | Pfizer Investigational Site | Pau | |
France | Pfizer Investigational Site | Perpignan | |
France | Pfizer Investigational Site | Poissy | |
France | Pfizer Investigational Site | Quetigny | |
France | Pfizer Investigational Site | Rillieux La Pape | |
France | Pfizer Investigational Site | Roanne | |
France | Pfizer Investigational Site | Roquebrune-Cap-Martin | |
France | Pfizer Investigational Site | Roye | |
France | Pfizer Investigational Site | Saint Laurent Du Var | |
France | Pfizer Investigational Site | Saint Quentin | |
France | Pfizer Investigational Site | Sainte-Maure-de-Touraine | |
France | Pfizer Investigational Site | Saintes | |
France | Pfizer Investigational Site | Salon De Provence | |
France | Pfizer Investigational Site | Sceaux | |
France | Pfizer Investigational Site | St. Girons | |
France | Pfizer Investigational Site | St. Maur Des Fosses | |
France | Pfizer Investigational Site | Toulon | |
France | Pfizer Investigational Site | Toulouse | |
France | Pfizer Investigational Site | Tremblay en France | |
France | Pfizer Investigational Site | Troyes | |
France | Pfizer Investigational Site | Vauvert | |
France | Pfizer Investigational Site | Vendome | |
France | Pfizer Investigational Site | Versailles | |
France | Pfizer Investigational Site | Viarmes | |
France | Pfizer Investigational Site | Villeneuve la Garenne | |
France | Pfizer Investigational Site | Villeparisis | |
France | Pfizer Investigational Site | Villiers Le Bel | |
France | Pfizer Investigational Site | Wasselonne |
Lead Sponsor | Collaborator |
---|---|
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | A positive response defined as an additional IOP reduction over 10% after 12 weeks of treatment in the intent to treat (ITT) population. | after 12 weeks of treatment | ||
Secondary | Absolute and relative IOP change after 4 and 12 weeks of treatment | week 4 and 12 | ||
Secondary | Percentage of patients achieving a target IOP value: under 18 mmHg and under 16 mmHg after 12 weeks of treatment, | week 12 |
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