Clinical trial NCT00804648: Patient Satisfaction With Timolol in Subjects With Open-Angle Glaucoma or Ocular Hypertension
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma, Open Angle
Ocular Hypertension
Lead sponsor: Vistakon Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-12-09
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Stinging on Instillation
timeFrame: following 3 days of treatment
Secondary outcomes:
measure: Conjunctival Hyperemia
timeFrame: following 3 days of treatment
measure: Tear Film Break-up Time
timeFrame: following 3 days of treatment
measure: Corneal Staining Grade
timeFrame: following 3 days of treatment
measure: Corneal Staining Count
timeFrame: following 3 days of treatment
measure: Intraoclular Pressure
timeFrame: following 3 days of treatment
measure: Basic Schirmer's
timeFrame: following 3 days of treatment
measure: Conjunctival Staining - Nasal Grade
timeFrame: following 3 days of treatment
measure: Conjunctival Staining - Nasal Count
timeFrame: following 3 days of treatment
measure: Conjunctival Staining - Temporal Grade
timeFrame: following 3 days of treatment
measure: Conjunctival Staining - Temporal Count
timeFrame: following 3 days of treatment
measure: Visual Acuity
timeFrame: following 3 days of treatment
Other outcomes:
Locations:
city: Bourbonnais
country: United States
state: Illinois
city: Charlotte
country: United States
state: North Carolina
Study officials:
affiliation: PRN Pharmacuetical Research Network, LLC
name: William C. Stewart, MD
role: STUDY_DIRECTOR
References: