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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02796560
• Other study ID #: 2016-1164
• Status: Completed
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

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

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