Effects of Latanoprost, Bimatoprost and Travoprost in Patients With Latanoprost-resistant Glaucoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01361841|
Recruitment Status : Unknown
Verified December 2010 by Centre de recherche du Centre hospitalier universitaire de Sherbrooke.
Recruitment status was: Recruiting
First Posted : May 27, 2011
Last Update Posted : May 27, 2011
Intraocular pressure (IOP) is considered to be the main risk factor for progression of glaucoma and therefore the main target of therapy. Pharmacologic treatment of glaucoma has changed considerably during the last decades due to the introduction of prostaglandin analogues. Three of these are commonly used in North America: latanoprost (Latanoprost T, Pfizer), Travoprost (Travatan TM, Alcon) and bimatoprost (Lumigan TM, Allergan).
There have been several studies to evaluate their effectiveness. The three seem to be equivalent, according to the only study that has compared the molecules. Latanoprost is employed initially, due to its paucity of side effects when compared to the other two analogues. However, if it is not effective, several studies ahve shown that a result is possible using either travoprost or bimatoprost. No study has been conducted to date systematically comparing the three molecules in cases of resistance to latanoprost. In actuality, the investigators patients will receive treatment identical to current practice with the exception of the group continuing with latanoprost. Several studies confirm the benefit of changing prostaglandin analogues if the first has not signficantly decreased the IOP (Palmberg et al. 2004). Each prostaglandin has unique properties which may cause the mechanism of action to vary slightly among patients. (cf. Pharmacological Aspects)
The goal of the study is thus to evaluate the efficaciousness of latanoprost, bimatoprost and travoprost in their IOP-lowering capacity in patients who do not initially respond to latanoprost.
|Condition or disease||Intervention/treatment||Phase|
|Ocular Hypertension Primary Glaucoma||Drug: Latanoprost, bimatoprost, travoprost Drug: travoprost, latanoprost and bimatoprost||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||141 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Latanoprost, Bimatoprost and Travoprost in Patients With Latanoprost-resistant Glaucoma|
|Study Start Date :||January 2009|
|Estimated Primary Completion Date :||January 2012|
|Estimated Study Completion Date :||January 2013|
Travoprost, latanoprost and bimatoprost, ophthalmic solution are topical medications used for controlling the progression of glaucoma or ocular hypertension, by reducing intraocular pressure. they are synthetic prostaglandin F 2α analogue (and prodrug for bimatoprost) that works by increasing the outflow of aqueous fluid from the eyes.
Drug: Latanoprost, bimatoprost, travoprost
topic drops, once a day at bedtime, for years
Drug: travoprost, latanoprost and bimatoprost
one drop once a day for life
- intraocular pressure [ Time Frame: 2 years ]A drop of fluorescein sodium and benoxinate hydrochloride, USP (0.25%/0.4%) will be instilled in the patient's eyes, after which baseline IOP will be measured by Goldmann tonometry. The inter-measurement variability is +/- 2mmHg.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01361841
|Centre hospitalier de Sherbrooke||Recruiting|
|Sherbrooke, Quebec, Canada, J1H 5N4|
|Contact: Pierre PB Blondeau, MD 1 (819) 346 1110 ext 28008 firstname.lastname@example.org|
|Principal Investigator:||Pierre Blondeau, MD||Centre de recherche du Centre hospitalier universitaire de Sherbrooke|