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
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Université de Sherbrooke
- Enrollment
- 76
- Locations
- 1
- Primary Endpoint
- Intraocular Pressure
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Brand name travoprost (Drug)
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.
Intervention: Generic travoprost (Drug)
Outcomes
Primary Outcomes
Intraocular Pressure
Time Frame: After 3 weeks of either the brand name or generic travoprost
Secondary Outcomes
- Comfort and Intolerance to the Drops Questionnaire(After 3 weeks of either the brand name or generic travoprost)