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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03284853 -
Safety and Efficacy Study of PG324 (Netarsudil/Latanoprost 0.02% / 0.005%) Ophthalmic Solution Compared to GANFORT® Ophthalmic Solution in Open Angle Glaucoma or Ocular Hypertension
|
Phase 3 | |
| Completed |
NCT01157364 -
Safety and Efficacy of a New Ophthalmic Formulation of Bimatoprost in Patients With Open Angle Glaucoma and Ocular Hypertension
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT06441643 -
Next Generation Rocklatan
|
Phase 2 | |
| Recruiting |
NCT02471105 -
Investigation of IOP and Tolerability of Bimatoprost 0.01% and Tafluprost Unit Dose Preservative Free 15 Microgram/ml
|
Phase 4 | |
| Recruiting |
NCT02792803 -
A Comparison of Xalatan (Latanoprost) to Apo-latanoprost and Co-latanoprost in the Treatment of Glaucoma
|
Phase 4 | |
| Terminated |
NCT02801617 -
Non-inferiority of PRO-067 Ophthalmic Solution vs GAAP Ofteno® in Glaucoma or Ocular Hypertension
|
Phase 3 | |
| Completed |
NCT02558374 -
Double-masked Study of Netarsudil (AR-13324) Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension
|
Phase 3 | |
| Completed |
NCT02246764 -
Study of Netarsudil (AR-13324) Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
|
Phase 3 | |
| Completed |
NCT02390245 -
Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study
|
N/A | |
| Completed |
NCT02338362 -
Inhaled Corticosteroids: Effect on Intraocular Pressure in Patients With Controlled Glaucoma
|
Phase 4 | |
| Completed |
NCT02993445 -
Effect of Alternate Therapies on Intraocular Pressure in Ocular Hypertension
|
N/A | |
| Completed |
NCT02628223 -
180 Degree vs. 360 Degree Selective Laser Trabeculoplasty as Initial Therapy for Glaucoma
|
N/A | |
| Completed |
NCT01995136 -
Investigation of Intraocular Pressure (IOP) Reduction Efficacy of Travoprost Ophthalmic Solution in Patients With Normal Tension Glaucoma
|
Phase 4 | |
| Completed |
NCT01936389 -
A Prospective Study to Assess the Hypotensive Efficacy of Rho-Kinase Inhibitor AR-12286 Ophthalmic Solution 0.5% and 0.7% in Patients With Exfoliation Syndrome and Ocular Hypertension or Glaucoma
|
Phase 2 | |
| Completed |
NCT02003547 -
A Single Centre Study to Evaluate 3 Ophthalmic Formulations in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT01693315 -
Multiple Dose-escalation Study of AMA0076 in Patients With Ocular Hypertension or Primary Open-angle Glaucoma
|
Phase 2 | |
| Completed |
NCT01664039 -
An Efficacy and Tolerability Study of TRAVATAN® Versus LUMIGAN®
|
Phase 4 | |
| Active, not recruiting |
NCT01430923 -
Clinical Evaluation of Safety and Efficacy of Refrigeration Free Latanoprost
|
N/A | |
| Completed |
NCT01426867 -
A Comfort Study of Brinzolamide 1% / Brimonidine 0.2% Fixed Combination, Brinzolamide 1% and Brimonidine 0.2%
|
Phase 2 | |
| Completed |
NCT01489670 -
Observational Study of Lumigan® 0.01% Treatment for Patients With Primary Open Angle Glaucoma or Ocular Hypertension
|
N/A |