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

Université de Sherbrooke76 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Glaucoma, Primary Open Angle Ocular Hypertension

Interventions

Depending on the arm, either brand name or generic Travoprost will be administered by the patient. After 3 weeks, the intraocular pressure will be measured and a crossover will happen. Patients having taken brand name Travoprost will be switched to generic Travoprost and vice versa. At 6 weeks, the intraocular pressure will be measured. Questionnaires on the comfort and intolerances of the drops will be administered at the visits of 3 and 6 weeks.

Generic travoprostDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Intraocular Pressure

Time frame: After 3 weeks of either the brand name or generic travoprost

Secondary Outcomes

Comfort and Intolerance to the Drops Questionnaire

Patients will be asked about: 1. Difficulties related to administration of the drops 2. Compliance to the drops 3. Side effects such as foreign body sensation, blurry vision, conjunctival redness, dry eyes, teary eyes, eye pain, eye pruritis, and a peri-ocular rash