Determination Of Predictive Factors Allowing To An Additional 10% Reduction Of Intra-Ocular Pressure
NCT00230763
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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,
- 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,
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Agen,
- Amboise,
- Amiens,
- Andresy,
- Asnieres Sur Seine,
- Aubiere,
- Aurillac,
- Belfort,
- Besancon,
- Beziers,
- Bordeaux,
- Bourg en Bresse,
- Caen,
- Cannes,
- Castelsarrasin,
- Chalon Sur Saone,
- Chalons en Champagne,
- Chamalieres-Royat,
- Chambery,
- Chartres,
- Chassieu,
- Chateau Renault,
- Chateaudun,
- Clamart,
- Clermont Ferrand,
- Clermont-Ferrand,
- Colmar,
- Coulommiers,
- Dax,
- Etampes,
- Figeac,
- Frejus,
- Goussainville,
- Haguenau,
- Hyeres,
- Issy Les Moulineaux,
- Ivry Sur Seine,
- Jarny,
- La Fleche,
- Langon,
- Lannion,
- Le Mans,
- Le Quesnoy,
- Les Clayes Sous Bois,
- Les Lilas,
- Lille,
- Limoges,
- Luxeuil Les Bains,
- Lyon,
- Lyon,
- Lyon,
- Marseille,
- Marseille,
- Marseille,
- Marseille,
- Meaux,
- Meudon,
- Meyzieu,
- Montargis,
- Montbeliard,
- Montigny Le Bretonneux,
- Moulins,
- Mulhouse,
- Nantes,
- Nemours,
- Nice,
- Noeux Les Mines,
- Orleans,
- Orsay,
- Pantin,
- Paris,
- Paris,
- Paris,
- Paris,
- Pau,
- Perpignan,
- Poissy,
- Quetigny,
- Rillieux La Pape,
- Roanne,
- Roquebrune-Cap-Martin,
- Roye,
- Saint Laurent Du Var,
- Saint Quentin,
- Sainte-Maure-de-Touraine,
- Saintes,
- Salon De Provence,
- Sceaux,
- St. Girons,
- St. Maur Des Fosses,
- Toulon,
- Toulouse,
- Tremblay en France,
- Troyes,
- Vauvert,
- Vendome,
- Versailles,
- Viarmes,
- Villeneuve la Garenne,
- Villeparisis,
- Villiers Le Bel,
- Wasselonne,
- Ichinomiya, Aichi
- Ichinomiya, Aichi
- Nagoya, Aichi
- Nagoya, Aichi
- Nagoya, Aichi
- Narashino, Chiba
- Sapporo, Hokkaido
- Sapporo, Hokkaido
- Sapporo, Hokkaido
- Sapporo, Hokkaido
- Koube, Hyogo
- Kanazawa, Ishikawa
- Fujisawa, Kanagawa
- Kamakura, Kanagawa
- Sagamihara, Kanagawa
- Yokohama, Kanagawa
- Sapporo, Kokkaido
- Uji, Kyoto
- Miyakonojo, Miyazaki
- Kumagaya, Saitama
- Tokorozawa, Saitama
- Fuji, Shizuoka
- Fuji, Shizuoka
- Mishima, Shizuoka
- Susono, Shizuoka
- Bunkyo-ku, Tokyo
- Chiyoda-ku, Tokyo
- Chiyoda, Tokyo
- Hachioji, Tokyo
- Hamura, Tokyo
- Katsushika-ku, Tokyo
- Kiyose, Tokyo
- Koto-ku, Tokyo
- Meguro-ku, Tokyo
- Meguro, Tokyo
- Musashino, Tokyo
- Musashino, Tokyo
- Ota-ku, Tokyo
- Setagaya, Tokyo
- Shinjuku, Tokyo
- Tachikawa, Tokyo
- Taito-ku, Tokyo
- Fujuoka,
- Fukuoka,
- Fukuoka,
- Fukuoka,
- Gifu,
- Hiroshima,
- Niigata,
- Osaka,
- Osaka,
- Osaka,
- Shizuoka,
- Sugita,
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 ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE |
| |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
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. 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. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 396 | |||
Original Enrollment ICMJE | 770 | |||
Actual Study Completion Date ICMJE | October 2007 | |||
Actual Primary Completion Date | October 2007 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | France | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00230763 | |||
Other Study ID Numbers ICMJE | A6641040 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer Inc | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | March 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |