24-Hour Intraocular Pressure (IOP) Control With Travoprost/Timolol Fixed Combination (TTFC) Versus Travoprost When Both Are Given PM in Subjects With Primary Open-Angle Glaucoma (POAG)

This study has been completed.

First Received: March 5, 2007 Last Updated: September 22, 2008 History of Changes

Sponsors and Collaborators:	Aristotle University Of Thessaloniki Alcon Research
Information provided by:	Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:	NCT00444184

Purpose

This 8-week, crossover study will compare the quality of 24-hour IOP control with TTFC versus travoprost when both medications are dosed in the evening.

Such a crossover comparison may determine the real efficacy of the new fixed combination versus travoprost monotherapy. The results should enhance our understanding on the best dosing of TTFC and may influence its clinical use in Europe. Finally, the results would better delineate the future role of TTFC in glaucoma management after PG monotherapy, or instead of unfixed therapy with PG analogs and timolol. This study should assist the general ophthalmologist worldwide to plan optimal stepwise medical therapy.

Condition	Intervention	Phase
Glaucoma	Drug: Travoprost/timolol fixed combination, travoprost	Phase IV

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

Drug Information available for: Timolol Timolol maleate Travoprost

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Active Control, Crossover Assignment, Efficacy Study
Official Title:	A Crossover, Double-Masked Comparison Investigating the 24-Hour Intraocular Pressure Control With the Travoprost/Timolol Fixed Combination Versus Travoprost, When Both Are Given in the Evening, in Subjects With Primary Open-Angle Glaucoma

Further study details as provided by Aristotle University Of Thessaloniki:

Primary Outcome Measures:

Mean 24-hour IOP [ Time Frame: end of study ]

Secondary Outcome Measures:

Secondary endpoints are:IOP, safety [ Time Frame: duration of study ]
Mean reduction from baseline, [ Time Frame: end of treatment periods ]
Mean fluctuation of 24-hour IOP [ Time Frame: end of treatment periods ]
Individual IOP readings measured at 10:00 (± 1 hour) and at +4, +8, +12, +16 and +20 (± 1 hour) hours. [ Time Frame: end of treatment periods ]

Enrollment:	32
Study Start Date:	March 2007
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	29 Years to 81 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Consecutive adults with primary open-angle glaucoma (POAG) who exhibit a mean untreated IOP greater than 23 m Hg at baseline (10:00).
Patient has POAG and is older than 29 years
The IOP without treatment is greater than 23 mm Hg and lower than 38 mm Hg at baseline (2 readings at 10:00)
Patient can be safely washed out without risk for significant deterioration
Distance best corrected Snellen visual acuity better than 1/10
Patient can understand the instructions and comply to medications
Open normal appearing angles

Exclusion Criteria:

Contraindications to prostaglandins or β-blockers
History of lack of response (<10% reduction) to any medication
Female of childbearing potential or lactating mother
History of trauma, inflammation, surgery, past use of steroids (within 2 months), severe dry eyes and use of contact lenses
Sign of ocular infection, except blepharitis, corneal abnormality that may affect IOP measurements etc

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00444184

Locations

Greece
Glaucoma Unit, 1st University Department of Ophthalmology
Thessaloniki, Greece, 546 36

Sponsors and Collaborators

Aristotle University Of Thessaloniki

Alcon Research

Investigators

Principal Investigator:

Anastasios GP Konstas, MD, PhD

Associate Professor and Head of the Glaucoma Unit, 1st University Department of Ophthalmology

More Information

No publications provided

Study ID Numbers:	A3243
Study First Received:	March 5, 2007
Last Updated:	September 22, 2008
ClinicalTrials.gov Identifier:	NCT00444184 History of Changes
Health Authority:	Greece: National Organization of Medicines

Keywords provided by Aristotle University Of Thessaloniki:

travoprost/timolol fixed combination

Study placed in the following topic categories:

Neurotransmitter Agents
Adrenergic Agents
Eye Diseases
Cardiovascular Agents
Antihypertensive Agents
Travoprost
Glaucoma

Glaucoma, Open-Angle
Adrenergic beta-Antagonists
Adrenergic Antagonists
Timolol
Anti-Arrhythmia Agents
Ocular Hypertension
Hypertension

Additional relevant MeSH terms:

Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Eye Diseases
Physiological Effects of Drugs
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Travoprost

Glaucoma
Therapeutic Uses
Glaucoma, Open-Angle
Adrenergic beta-Antagonists
Adrenergic Antagonists
Anti-Arrhythmia Agents
Timolol
Ocular Hypertension

ClinicalTrials.gov processed this record on May 06, 2009