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

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
Glaucoma, Primary Open Angle, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: Brand name travoprost
* Drug: Generic travoprost


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brand name travoprost<br>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<br>* 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.<br>* Other names: Travatan Z;|
| Experimental: Generic travoprost<br>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<br>* 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.<br>* Other names: Travoprost;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Drugs, Generic, Generic Equivalency