Recruiting

Latanoprost, Bimatoprost, Travoprost

Sponsor:

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Code:

NCT01361841

Conditions

Ocular Hypertension

Primary Glaucoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Latanoprost, bimatoprost, travoprost

travoprost, latanoprost and bimatoprost

Study Details

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

Study ID

NCT01361841

Start date

Jan, 2009

Status verified date

Dec, 2010

Completion date

Jan, 2013

Anticipated

Primary completion date

Jan, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

141 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: 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.

Interventions

Latanoprost, bimatoprost, travoprost

topic drops, once a day at bedtime, for years

travoprost, latanoprost and bimatoprost

one drop once a day for life

Primary outcome measure

  • intraocular pressure [ Time Frame: 2 years ]

Central Contacts and Locations

Locations

Centre hospitalier de Sherbrooke

Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

Contacts

More Information

Sponsor

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Last update posted

May 27, 2011

Last verified

Dec, 2010

Keywords

  • Latanoprost
  • bimatoprost
  • travoprost
  • non responders

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by Centre de recherche du Centre hospitalier universitaire de Sherbrooke on 2011-05-27. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.