Generic Travoprost Versus Brand Name Travoprost in Patients With Primary Open Angle Glaucoma or Ocular Hypertension

• Status: Completed
• Trial end date: 2017-09-12
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the efficacy and tolerance of generic travoprost with its brand name formulation. In this open label, randomized, crossover study, the primary outcome will be intraocular pressure and the secondary outcome will be tolerance to the drops, as measured by a subjective questionnaire. Patients will be randomized to receive either brand name or generic travoprost during the first visit. At the second visit 3 weeks later, their intraocular pressure will be measured and a questionnaire will be completed on the tolerance of the medication. Patients will then receive the other formulation of travoprost. At the third and final visit, another 3 weeks later, their intraocular pressure will be measured and a questionnaire will be completed on the tolerance of the second medication.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Université de Sherbrooke
• Treatments: Travoprost

Criteria

Inclusion Criteria:

• Be apt to give consent

• Have a diagnostic of primary open angle glaucoma or ocular hypertension requiring treatment

Exclusion Criteria:

• Angle closure glaucoma or having benefited from a peripheral iridotomy

• Known allergies to travoprost or to one of the ingredients

• Current usage of other glaucoma drops other than travoprost

• Current usage of topical corticosteroids

• Pregnancy

• Breast feeding

• Monophthalmic

• Having benefited from glaucoma surgery including trabeculectomies, implant drainage devices, and selective laser trabeculectomies

• Active intraocular inflammation

• Ocular surface disease that interferes with accurate measuring of the intraocular pressure

• Any clinically significant ocular disease that could interfere with the study