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

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ClinicalTrials.gov Identifier: NCT02796560
Recruitment Status : Unknown
Verified March 2016 by Université de Sherbrooke.
Recruitment status was:  Not yet recruiting
First Posted : June 10, 2016
Last Update Posted : June 10, 2016
Sponsor:
Information provided by (Responsible Party):
Université de Sherbrooke

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.

Condition or disease Intervention/treatment Phase
Glaucoma, Primary Open Angle Ocular Hypertension Drug: Brand name travoprost Drug: Generic travoprost Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : July 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Travoprost

Arm Intervention/treatment
Experimental: 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.
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.
Other Name: Travatan Z

Experimental: 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.
Drug: 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.
Other Name: Travoprost




Primary Outcome Measures :
  1. Intraocular pressure [ Time Frame: At 3 weeks ]
  2. Intraocular pressure [ Time Frame: At 6 weeks ]

Secondary Outcome Measures :
  1. Comfort and intolerance to the drops questionnaire [ Time Frame: At 3 weeks ]

    Patients will be asked about:

    1. Difficulties related to administration of the drops
    2. Compliance to the drops
    3. Side effects such as foreign body sensation, blurry vision, conjunctival redness, dry eyes, teary eyes, eye pain, eye pruritis, and a peri-ocular rash

  2. Comfort and intolerance to the drops questionnaire [ Time Frame: At 6 weeks ]

    Patients will be asked about:

    1. Difficulties related to administration of the drops
    2. Compliance to the drops
    3. Side effects such as foreign body sensation, blurry vision, conjunctival redness, dry eyes, teary eyes, eye pain, eye pruritis, and a peri-ocular rash



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796560


Contacts
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Contact: David Ta Kim, MD (819) 346-1110 ext 28008 david.ta.kim@usherbrooke.ca
Contact: Marjorie Carbonneau, MD, FRCS(C) marjorie.carbonneau@usherbrooke.ca

Locations
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Canada, Quebec
Hotel-Dieu de Sherbrooke (CHUS) Not yet recruiting
Sherbrooke, Quebec, Canada, J1G 2E8
Contact: David Ta Kim, MD    (819) 346-1110 ext 28008    david.ta.kim@usherbrooke.ca   
Contact: Marjorie Carbonneau, MD, FRCS(C)       marjorie.carbonneau@usherbrooke.ca   
Principal Investigator: Marjorie Carbonneau, MD, FRCS(C)         
Sub-Investigator: David Ta Kim, MD         
Sponsors and Collaborators
Université de Sherbrooke
Investigators
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Principal Investigator: Marjorie Carbonneau, MD, FRCS(C) Université de Sherbrooke, Hôtel Dieu de Sherbrooke

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Responsible Party: Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT02796560     History of Changes
Other Study ID Numbers: 2016-1164
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: June 10, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Université de Sherbrooke:
Drugs, Generic
Generic Equivalency

Additional relevant MeSH terms:
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Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Travoprost
Antihypertensive Agents