Ocular Hypertension Clinical Trial
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
Verified date | December 2017 |
Source | Université de Sherbrooke |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 76 |
Est. completion date | September 12, 2017 |
Est. primary completion date | September 12, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Hotel-Dieu de Sherbrooke (CHUS) | Sherbrooke | Quebec |
Lead Sponsor | Collaborator |
---|---|
Université de Sherbrooke |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intraocular Pressure | After 3 weeks of either the brand name or generic travoprost | ||
Secondary | 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 |
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