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

NCT01361841 | Unknown DMC

• 1 other identifier: CHUS-09-184
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ocular Hypertension; Primary Glaucoma

Keywords

Latanoprost; bimatoprost; travoprost; non responders

Outcome Measures

Primary Outcomes (1)

• intraocular pressure

  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.

  2 years

Study Arms (1)

ophtalmic solution,

OTHER

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; Drug: travoprost, latanoprost and bimatoprost

Interventions

Latanoprost, bimatoprost, travoprost DRUG

topic drops, once a day at bedtime, for years

Also known as: Xalatan, Lumigan, Travatan

ophtalmic solution,

travoprost, latanoprost and bimatoprost DRUG

one drop once a day for life

Also known as: Travatan, Xalatan, Lumigan

ophtalmic solution,

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre de recherche du Centre hospitalier universitaire de Sherbrooke: lead

Study Sites (1)

Centre hospitalier de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

RECRUITING

MeSH Terms

Conditions

Ocular Hypertension

Interventions

Latanoprost; Bimatoprost; Travoprost

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Amides; Organic Chemicals; Cloprostenol

Study Officials

• Pierre Blondeau, MD

  Centre de recherche du Centre hospitalier universitaire de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 25, 2011
• First Posted: May 27, 2011
• Study Start: January 1, 2009
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2013
• Last Updated: May 27, 2011

Record last verified: 2010-12

Locations

CA (1)