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

NCT ID: NCT02796560

Last Updated: 2020-12-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-01

Study Completion Date

2017-09-12

Brief Summary

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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.

Detailed Description

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Conditions

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Glaucoma, Primary Open Angle Ocular Hypertension

Keywords

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Drugs, Generic Generic Equivalency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Brand name travoprost

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.

Group Type EXPERIMENTAL

Brand name travoprost

Intervention Type DRUG

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 travoprost

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.

Group Type EXPERIMENTAL

Generic travoprost

Intervention Type DRUG

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.

Interventions

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Brand name travoprost

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.

Intervention Type DRUG

Generic travoprost

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.

Intervention Type DRUG

Other Intervention Names

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Travatan Z Travoprost

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Université de Sherbrooke

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marjorie Carbonneau, MD, FRCS(C)

Role: PRINCIPAL_INVESTIGATOR

Université de Sherbrooke, Hôtel Dieu de Sherbrooke

Locations

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Hotel-Dieu de Sherbrooke (CHUS)

Sherbrooke, Quebec, Canada

Site Status

Countries

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Canada

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2016-1164

Identifier Type: -

Identifier Source: org_study_id