Status:
COMPLETED
Patient Satisfaction With Timolol in Subjects With Open-Angle Glaucoma or Ocular Hypertension
Lead Sponsor:
Vistakon Pharmaceuticals
Conditions:
Glaucoma, Open Angle
Ocular Hypertension
Eligibility:
All Genders
21+ years
Phase:
PHASE4
Brief 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
- 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
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00804648
Start Date
November 1 2008
End Date
December 1 2008
Last Update
March 6 2015
Active Locations (2)
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1
Bourbonnais, Illinois, United States
2
Charlotte, North Carolina, United States