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

Université de Sherbrooke

Status and phase: Completed; Phase 4

Conditions: Glaucoma, Primary Open Angle; Ocular Hypertension

Treatments: Drug: Brand name travoprost; Drug: Generic travoprost

Study type: Interventional

Funder types: Other

Identifiers

NCT02796560

2016-1164

Details and patient eligibility

About

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.

Enrollment: 76 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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76 participants in 2 patient groups

Brand name travoprost

Experimental group

Description:

Patients will be randomized to either start in this arm for the first 3 weeks before the crossover to the other arm for the second 3 weeks or they will start in the other arm for the first 3 weeks before the crossover to this arm for the second 3 weeks.

Treatment:

Drug: Brand name travoprost

Generic travoprost

Experimental group

Description:

Patients will be randomized to either start in this arm for the first 3 weeks before the crossover to the other arm for the second 3 weeks or they will start in the other arm for the first 3 weeks before the crossover to this arm for the second 3 weeks.

Treatment:

Drug: Generic travoprost