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

Sponsored by:	Vistakon Pharmaceuticals
Information provided by:	Vistakon Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00804648

Purpose

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

Condition	Intervention	Phase
Glaucoma, Open Angle Ocular Hypertension	Drug: Timolol Maleate in Sorbate Drug: Timolol hemihydrate Drug: Timolol maleate gel forming solution	Phase IV

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

Drug Information available for: Timolol Timolol maleate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment
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

Further study details as provided by Vistakon Pharmaceuticals:

Primary Outcome Measures:

stinging on instillation [ Time Frame: following 3 days of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

conjunctival hyperemia [ Time Frame: following 3 days of treatment ] [ Designated as safety issue: Yes ]
tear film break-up time [ Time Frame: following 3 days of treatment ] [ Designated as safety issue: Yes ]
fluorescein staining [ Time Frame: following 3 days of treatment ] [ Designated as safety issue: Yes ]
lissamine green staining [ Time Frame: following 3 days of treatment ] [ Designated as safety issue: Yes ]
intraoclular pressure [ Time Frame: following 3 days of treatment ] [ Designated as safety issue: Yes ]
Basic Schirmer's [ Time Frame: following 3 days of treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	November 2008
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Period one - Timolol hemihydrate 0.5% Period two - Timolol maleate 0.5% Period three - Timolol maleate gel forming solution 0.5%	Drug: Timolol Maleate in Sorbate 0.5% Drug: Timolol hemihydrate 0.5% Drug: Timolol maleate gel forming solution 0.5%
2: Active Comparator Period one - Timolol maleate 0.5% Period two - Timolol maleate gel forming solution 0.5% Period three - Timolol hemihydrate 0.5%	Drug: Timolol Maleate in Sorbate 0.5% Drug: Timolol hemihydrate 0.5% Drug: Timolol maleate gel forming solution 0.5%
3: Active Comparator Period one - Timolol maleate gel forming solution 0.5% Period two - Timolol hemihydrate 0.5% Period three - Timolol maleate 0.5%	Drug: Timolol Maleate in Sorbate 0.5% Drug: Timolol hemihydrate 0.5% Drug: Timolol maleate gel forming solution 0.5%
4: Active Comparator Period one - Timolol hemihydrate 0.5% Period two - Timolol maleate gel forming solution 0.5% Period three - Timolol maleate 0.5%	Drug: Timolol Maleate in Sorbate 0.5% Drug: Timolol hemihydrate 0.5% Drug: Timolol maleate gel forming solution 0.5%
5: Active Comparator Period 1 - Timolol maleate 0.5% Period 2 - Timolol hemihydrate 0.5% Period 3 - Timolol maleate gel forming solution 0.5%	Drug: Timolol Maleate in Sorbate 0.5% Drug: Timolol hemihydrate 0.5% Drug: Timolol maleate gel forming solution 0.5%
6: Active Comparator Period 1 - Timolol maleate gel forming solution 0.5% Period 2 - Timolol maleate 0.5% Period 3 - Timolol hemihydrate 0.5%	Drug: Timolol Maleate in Sorbate 0.5% Drug: Timolol hemihydrate 0.5% Drug: Timolol maleate gel forming solution 0.5%

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00804648

Locations

United States, Illinois
	Recruiting
Bourbonnais, Illinois, United States
Contact: Sriram Sonty, MD (815) 939-3528 ssonty@msn.com
Principal Investigator: Sriram Sonty, MD
United States, North Carolina
	Recruiting
Charlotte, North Carolina, United States
Contact: Thomas Mundorf, MD (704)334-3222 tommundorf@aol.com
Principal Investigator: Thomas Mundorf, MD

Sponsors and Collaborators

Vistakon Pharmaceuticals

Investigators

Study Director:

William C. Stewart, MD

PRN Pharmacuetical Research Network, LLC

More Information

Responsible Party:	Vistakon Pharmaceuticals LLC ( Arthur Shedden, MD, Director Medical Affairs )
Study ID Numbers:	VPH0111
Study First Received:	December 5, 2008
Last Updated:	December 5, 2008
ClinicalTrials.gov Identifier:	NCT00804648
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Glaucoma
Eye Diseases
Glaucoma, Open-Angle
Vascular Diseases

Timolol
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Therapeutic Uses
Physiological Effects of Drugs
Adrenergic beta-Antagonists

Adrenergic Antagonists
Cardiovascular Diseases
Cardiovascular Agents
Anti-Arrhythmia Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009