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

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.

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.

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

Bourbonnais, Illinois, United States

Charlotte, North Carolina, United States

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