24-hr IOP With Travoprost/Timolol Compared With Latanoprost/Timolol in XFG - Full Text View

Sponsors and Collaborators:	Aristotle University Of Thessaloniki Alcon Research
Information provided by:	Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:	NCT00757835

Purpose

A crossover, randomized, single-masked study which compares the short-term (3 months) 24-hour IOP control and safety of travoprost/timolol fixed combination given once in the evening, versus that of latanoprost/timolol fixed combination given once in the evening in patients with exfoliative glaucoma. The primary objective of this trial is to compare the quality of 24-hour IOP control after 3 months of chronic therapy with these two medications.

Condition	Intervention	Phase
Glaucoma	Drug: treatment with latanoprost/timolol fixed combination Drug: latanoprost/timolol fixed combination drops	Phase IV

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

Drug Information available for: Latanoprost Travoprost Timolol Timolol maleate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	24-Hour IOP Control With the Travoprost/Timolol Fixed Combination Compared With the Latanoprost/Timolol Fixed Combination, When Both Are Dosed in the Evening in Patients With Exfoliative Glaucoma

Further study details as provided by Aristotle University Of Thessaloniki:

Primary Outcome Measures:

Travoprost/timolol fixed combination will demonstrate better quality of 24-hour IOP control than latanoprost/timolol [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of side effects with the two medications [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment:	40
Study Start Date:	May 2008
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator treatment with travoprost/timolol fixed combination drops once in the evening	Drug: treatment with latanoprost/timolol fixed combination dosing in the evening with the two fixed combinations
B: Active Comparator Treatment with latanoprost/timolol fixed combination	Drug: latanoprost/timolol fixed combination drops once in the evening

Eligibility

Ages Eligible for Study:	21 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient has XFG and is older than 29 years
The IOP without treatment is greater than 25 mm Hg and lower than 40 mm Hg at baseline (2 readings at 10:00)
Patient can be safely washed out without risk for significant deterioration
Distance best corrected Snelen visual acuity better than 0.1
No contraindication to prostaglandins or β-blockers
No history of lack of response (<10% reduction) to any medication
Patient can understand the instructions and comply to medications
Open normal appearing angles
No sign of ocular infection, except blepharitis, corneal abnormality that may affect IOP measurements etc

Exclusion Criteria:

History of trauma, inflammation, surgery, past use of steroids (within 2 months), severe dry eyes and use of contact lenses
Patient is a female of childbearing potential or lactating mother

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00757835

Sponsors and Collaborators

Aristotle University Of Thessaloniki

Alcon Research

Investigators

Principal Investigator:

Anastasios G Konstas, MD, PhD

Glaucoma Unit, 1st University Department of Ophthalmology

More Information

Responsible Party:	Glaucoma Unit, 1st University Department of Ophthalmology ( Associate Professor AGP Konstas )
Study ID Numbers:	A6219
Study First Received:	September 19, 2008
Last Updated:	November 7, 2008
ClinicalTrials.gov Identifier:	NCT00757835
Health Authority:	Greece: National Organization of Medicines

Keywords provided by Aristotle University Of Thessaloniki:

24-hour IOP
exfoliative glaucoma
travoprost/timolol
latanoprost/timolol
fixed combinations

Study placed in the following topic categories:

Glaucoma
Eye Diseases
Timolol
Latanoprost

Travoprost
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 Agents
Anti-Arrhythmia Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009