Patient Satisfaction With Timolol in Subjects With Open-Angle Glaucoma or Ocular Hypertension
Condition: Glaucoma, Open Angle; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Timolol Maleate in Sorbate; Timolol hemihydrate; Timolol maleate gel forming solution
Intervention description: 0.5%; 0.5%; 0.5%
Intervention MeSH terms: Timolol; Maleic acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No

Summary:

      This study compares patient symptoms and anterior segment safety in patients treated with
      timolol hemihydrate, generic timolol gel forming solution or timolol maleate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  willing to comply with investigator's and protocol's instructions

          -  patients signature on the informed consent document

          -  primary open-angle glaucoma, pigment dispersion or exfoliation glaucoma, or ocular
             hypertension in at least one eye

          -  at screening intraocular pressure must be considered to be safe, in both eyes

          -  in non-qualifying eyes the intraocular pressure should be able to be controlled safely
             on no pharmacologic therapy or on study medicine alone

          -  currently treated with one glaucoma medication, untreated intraocular pressure of less
             than or equal to 28 mm Hg at visit 2 in both eyes

        Exclusion Criteria:

          -  any abnormality preventing reliable applanation tonometry in either eye

          -  any opacity or subject uncooperativeness that restricts adequate examination of the
             ocular fundus or anterior chamber in either eye

          -  any concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either
             eye

          -  any history of allergic hypersensitivity or poor tolerance to any components of the
             preparations used in this trial

          -  females of childbearing potential not using reliable means of birth control

          -  pregnant or lactating females

          -  any clinically significant, serious, or severe medical or psychiatric condition

          -  participation (or current participation) in any investigational drug or device trial
             within 30 days prior to Visit 1

          -  severe prior visual acuity or field loss from any cause

          -  inability to understand the trial procedures, and thus inability to give informed
             consent

          -  progressive retinal or optic nerve disease apart from glaucoma

          -  serious systemic or ocular disease

          -  intraocular laser surgery within the past three months or corneal or intraocular
             conventional surgery within the past 6 months

          -  concurrent use of systemic corticosteroids, by IV, oral, dermal or topical ophthalmic
             route.

          -  subjects requiring tear replacement drops or allergy medications with sympathomimetics
             24 hours prior to a scheduled study visit

          -  contraindication to beta-blocker usage including: reactive airway disease,
             uncontrolled heart failure, or second as well as third degree cardiac block,
             myasthenia gravis

          -  any subject the investigator believes will be at risk for glaucomatous progression by
             their participation in this trial