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

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vistakon Pharmaceuticals
• Treatments: Maleic acid; Pharmaceutical Solutions; Timolol

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