Generic Travoprost Versus Brand Name Travoprost in Patients With Primary Open Angle Glaucoma or Ocular Hypertension
Primary Purpose
Glaucoma, Primary Open Angle, Ocular Hypertension
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Brand name travoprost
Generic travoprost
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma, Primary Open Angle focused on measuring Drugs, Generic, Generic Equivalency
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
Sites / Locations
- Hotel-Dieu de Sherbrooke (CHUS)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Brand name travoprost
Generic travoprost
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Intraocular Pressure
Secondary Outcome Measures
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
Full Information
NCT ID
NCT02796560
First Posted
May 24, 2016
Last Updated
November 30, 2020
Sponsor
Université de Sherbrooke
1. Study Identification
Unique Protocol Identification Number
NCT02796560
Brief Title
Generic Travoprost Versus Brand Name Travoprost in Patients With Primary Open Angle Glaucoma or Ocular Hypertension
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
July 1, 2016 (Actual)
Primary Completion Date
September 12, 2017 (Actual)
Study Completion Date
September 12, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Université de Sherbrooke
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Primary Open Angle, Ocular Hypertension
Keywords
Drugs, Generic, Generic Equivalency
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brand name travoprost
Arm Type
Experimental
Arm Description
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.
Arm Title
Generic travoprost
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Brand name travoprost
Other Intervention Name(s)
Travatan Z
Intervention Description
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
Intervention Name(s)
Generic travoprost
Other Intervention Name(s)
Travoprost
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intraocular Pressure
Time Frame
After 3 weeks of either the brand name or generic travoprost
Secondary Outcome Measure Information:
Title
Comfort and Intolerance to the Drops Questionnaire
Description
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
Time Frame
After 3 weeks of either the brand name or generic travoprost
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marjorie Carbonneau, MD, FRCS(C)
Organizational Affiliation
Université de Sherbrooke, Hôtel Dieu de Sherbrooke
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hotel-Dieu de Sherbrooke (CHUS)
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1G 2E8
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Generic Travoprost Versus Brand Name Travoprost in Patients With Primary Open Angle Glaucoma or Ocular Hypertension
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