Patient Satisfaction With Timolol in Subjects With Open-Angle Glaucoma or Ocular Hypertension

Completed · Phase 4

Conditions studied: Glaucoma, Open Angle, Ocular Hypertension

In brief

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

Key facts

Study ID

NCT00804648

Run by

Vistakon Pharmaceuticals

People needed

30

Starts

2008-11-01

Expected to finish

2008-12-01

Last updated by the study team

2015-03-06

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Bourbonnais, Illinois, United States
• Study site — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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