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Completed

NCT Number: NCT02796560

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

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.

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Key information

Conditions

Glaucoma, Primary Open Angle Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hotel-Dieu de Sherbrooke (CHUS)

Sherbrooke, Quebec, J1G 2E8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brand name travoprost

Drug

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.

Other names: Travatan Z

Generic travoprost

Drug

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.

Other names: Travoprost

Primary outcomes

  1. Intraocular Pressure

    Time frame: After 3 weeks of either the brand name or generic travoprost

Secondary outcomes

  1. Comfort and Intolerance to the Drops Questionnaire

    Time frame: After 3 weeks of either the brand name or generic travoprost

    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

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 10, 2016
Registry last updated
Dec 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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