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

Information source: Vistakon Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Glaucoma, Open Angle; Ocular Hypertension

Intervention: Timolol Maleate in Sorbate (Drug); Timolol hemihydrate (Drug); Timolol maleate gel forming solution (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Vistakon Pharmaceuticals

Official(s) and/or principal investigator(s):
William C. Stewart, MD, Study Director, Affiliation: PRN Pharmacuetical Research Network, LLC


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

Clinical Details

Official title: Patient Satisfaction With Timolol Maleate in Sorbate, Generic Timolol Gel Forming Solution or Timolol Hemihydrate in Subjects With Open-Angle Glaucoma or Ocular Hypertension

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Stinging on Instillation

Secondary outcome:

Conjunctival Hyperemia

Tear Film Break-up Time

Corneal Staining Grade

Corneal Staining Count

Intraoclular Pressure

Basic Schirmer's

Conjunctival Staining - Nasal Grade

Conjunctival Staining - Nasal Count

Conjunctival Staining - Temporal Grade

Conjunctival Staining - Temporal Count

Visual Acuity


Minimum age: 21 Years. Maximum age: N/A. Gender(s): Both.


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


- 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


- 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

Locations and Contacts

Bourbonnais, Illinois, United States

Charlotte, North Carolina, United States

Additional Information

Starting date: November 2008
Last updated: February 18, 2015

Page last updated: August 23, 2015

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