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

NCT02796560 | Completed Phase 4 Results DMC

• 1 other identifier: 2016-1164
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glaucoma, Primary Open Angle; Ocular Hypertension

Keywords

Drugs, Generic; Generic Equivalency

Outcome Measures

Primary Outcomes (1)

• Intraocular Pressure

  After 3 weeks of either the brand name or generic travoprost

Secondary Outcomes (1)

• Comfort and Intolerance to the Drops Questionnaire

  After 3 weeks of either the brand name or generic travoprost

Study Arms (2)

Brand name travoprost

EXPERIMENTAL

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

Generic travoprost

EXPERIMENTAL

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

Interventions

Brand name travoprost 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.

Also known as: Travatan Z

Brand name travoprost

Generic travoprost 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.

Also known as: Travoprost

Generic travoprost

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be apt to give consent
• Have a diagnostic of primary open angle glaucoma or ocular hypertension requiring treatment

You may not qualify if:

• 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

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (1)

Hotel-Dieu de Sherbrooke (CHUS)

Sherbrooke, Quebec, J1G 2E8, Canada

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

Travoprost

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Intervention Hierarchy (Ancestors)

Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Results Point of Contact

• Title: Dr Marjorie Carbonneau
• Organization: University of Sherbrooke

Marjorie.Carbonneau@USherbrooke.ca

819-346-1110

Study Officials

• Marjorie Carbonneau, MD, FRCS(C)

  Université de Sherbrooke, Hôtel Dieu de Sherbrooke

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2016
• First Posted: June 10, 2016
• Study Start: July 1, 2016
• Primary Completion: September 12, 2017
• Study Completion: September 12, 2017
• Last Updated: December 1, 2020
• Results First Posted: December 1, 2020

Record last verified: 2017-12

Locations

CA (1)