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

Randomized Crossover Trial Comparing the Hypotensive Effect of Generic Travoprost With That of the Brand Name Travoprost in Patients With Primary Open Angle Glaucoma or Ocular Hypertension

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 Overview

• Status: Completed
• Conditions: Ocular Hypertension; Glaucoma, Primary Open Angle
• Intervention / Treatment: Drug: Brand name travoprost; Drug: Generic travoprost

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Sherbrooke, Quebec, Canada, J1G 2E8
      • Hotel-Dieu de Sherbrooke (CHUS)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.; Other Names: Travatan Z
Experimental: 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.	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.; Other Names: Travoprost

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Intraocular Pressure	After 3 weeks of either the brand name or generic travoprost

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comfort and Intolerance to the Drops Questionnaire	Patients will be asked about: Difficulties related to administration of the drops; Compliance to the drops; Side effects such as foreign body sensation, blurry vision, conjunctival redness, dry eyes, teary eyes, eye pain, eye pruritis, and a peri-ocular rash	After 3 weeks of either the brand name or generic travoprost

Collaborators and Investigators

• Sponsor: Université de Sherbrooke
• Investigators: Principal Investigator: Marjorie Carbonneau, MD, FRCS(C), Université de Sherbrooke, Hôtel Dieu de Sherbrooke

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): September 12, 2017
• Study Completion (Actual): September 12, 2017

Study Registration Dates

• First Submitted: May 24, 2016
• First Submitted That Met QC Criteria: June 6, 2016
• First Posted (Estimate): June 10, 2016

Study Record Updates

• Last Update Posted (Actual): December 1, 2020
• Last Update Submitted That Met QC Criteria: November 30, 2020
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Drugs, Generic; Generic Equivalency
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Antihypertensive Agents; Travoprost
• Other Study ID Numbers: 2016-1164

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED