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

Phase 4

Completed

• Conditions: Ocular Hypertension; Glaucoma, Primary Open Angle
• Interventions: Drug: Generic travoprost; Drug: Brand name travoprost

• Registration Number: NCT02796560
• Lead Sponsor: Université de Sherbrooke

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-24
• Study First Submitted QC: 2016-06-06
• Study First Posted: 2016-06-10
• Study Start: 2016-07-01
• Primary Completion: 2017-09-12
• Study Completion: 2017-09-12
• Status Verified: 2017-12
• Results First Submitted: 2018-10-22
• Results First Submitted QC: 2020-11-30
• Last Update Submitted: 2020-11-30
• Results First Posted: 2020-12-01
• Last Update Posted: 2020-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Generic travoprost	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.
Brand name travoprost	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.

Primary Outcome Measures

Name	Time	Method
Intraocular Pressure	After 3 weeks of either the brand name or generic travoprost

Secondary Outcome Measures

Name	Time	Method
Comfort and Intolerance to the Drops Questionnaire	After 3 weeks of either the brand name or generic travoprost	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

Trial Locations

Locations (1)

Hotel-Dieu de Sherbrooke (CHUS); 🇨🇦 Sherbrooke, Quebec, Canada