Effects of Latanoprost, Bimatoprost and Travoprost in Patients With Latanoprost-resistant Glaucoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Centre Hospitalier Universitaire de Sherbrooke.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Centre Hospitalier Universitaire de Sherbrooke
ClinicalTrials.gov Identifier:
NCT01361841
First received: May 25, 2011
Last updated: May 26, 2011
Last verified: December 2010
  Purpose

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 Intervention
Ocular Hypertension
Primary Glaucoma
Drug: Latanoprost, bimatoprost, travoprost
Drug: travoprost, latanoprost and bimatoprost

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Latanoprost, Bimatoprost and Travoprost in Patients With Latanoprost-resistant Glaucoma

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Sherbrooke:

Primary Outcome Measures:
  • intraocular pressure [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 141
Study Start Date: January 2009
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
ophtalmic solution,
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
Other Names:
  • Xalatan
  • Lumigan
  • Travatan
Drug: travoprost, latanoprost and bimatoprost
one drop once a day for life
Other Names:
  • Travatan
  • Xalatan
  • Lumigan

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients diagnosed with ocular hypertension or primary open-angle glaucoma who have never received treatment.
  • Age 18 or older and able to give informed consent

Exclusion Criteria:

  • Patients with intraocular inflammation of any etiology
  • Patients with advanced glaucoma, defined by severe optic nerve damage and/or visual field deficit.
  • Patients having had intraocular surgery in the last 4 weeks
  • Patients undergoing treatment with ophthalmic solution of any kind
  • Patients unable to give informed consent to participate in the research project,including those suffering from psychiatric illness resulting in impaired judgement
  • Monophthalmia or anophthalmia
  • Pregnant or nursing patients
  • Patients status post ocular surgery, with the exception of cataract extraction surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01361841

Locations
Canada, Quebec
Centre hospitalier de Sherbrooke Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Pierre PB Blondeau, MD    1 (819) 346 1110 ext 28008    pierre.blondeau@videotron.ca   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Sherbrooke
Investigators
Principal Investigator: Pierre Blondeau, MD Centre Hospitalier Universitaire de Sherbrooke
  More Information

No publications provided

Responsible Party: Centre Hostitalier Universitaire de Sherbrooke, CHUS
ClinicalTrials.gov Identifier: NCT01361841     History of Changes
Other Study ID Numbers: CHUS-09-184
Study First Received: May 25, 2011
Last Updated: May 26, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by Centre Hospitalier Universitaire de Sherbrooke:
Latanoprost
bimatoprost
travoprost
non responders

Additional relevant MeSH terms:
Glaucoma
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Latanoprost
Travoprost
Bimatoprost
Cloprostenol
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2014