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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02796560
Other study ID # 2016-1164
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date July 1, 2016
Est. completion date September 12, 2017

Study information

Verified date December 2017
Source Université de Sherbrooke
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Intervention

Drug:
Brand name travoprost
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.
Generic travoprost
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.

Locations

Country Name City State
Canada Hotel-Dieu de Sherbrooke (CHUS) Sherbrooke Quebec

Sponsors (1)

Lead Sponsor Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

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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