Generic Travoprost Versus Brand Name Travoprost in Patients With Primary Open Angle Glaucoma or Ocular Hypertension
Condition: Glaucoma, Primary Open Angle; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Brand name travoprost; Generic travoprost
Intervention description: 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.; 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.
Intervention MeSH terms: Travoprost
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 76.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Drugs, Generic; Generic Equivalency

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.
    

Eligibility 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