Travoprost/Timolol vs Latanoprost/Timolol Fixed Combination Therapy - Full Text View

Purpose

The primary objective of this crossover trial is to compare the 3-month, mean 24-hour intraocular pressure (IOP) control and safety obtained with two popular fixed combinations in glaucoma patients insufficiently controlled with latanoprost monotherapy. This study will compare the 24-hour efficacy of travoprost/timolol fixed combination without benzalkonium chloride given once in the evening, versus the latanoprost/timolol fixed combination given in the evening. It is assumed that travoprost/timolol fixed combination will provide better quality of 24-hour pressure control.

Condition	Intervention	Phase
Glaucoma	Drug: Travoprost/timolol therapy Drug: Latanoprost/Timolol therapy	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Official Title:	24-Hour Efficacy of Travoprost/Timolol Benzalkonium Chloride BAK Free Compared With Latanoprost/Timolol Fixed Combination Therapy in Subjects With Open-Angle Glaucoma Insufficiently Controlled With Latanoprost Monotherapy

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

Drug Information available for: Timolol Timolol maleate Latanoprost Travoprost

Genetic and Rare Diseases Information Center resources: Pigment-dispersion Syndrome

U.S. FDA Resources

Further study details as provided by Aristotle University Of Thessaloniki:

Primary Outcome Measures:

Mean 24-hour intraocular pressure reduction between the two medications [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Evaluation of 24-hour pressure every 4 hours at habitual position with calibrated Goldmann technology tonometer

Secondary Outcome Measures:

rate of adverse events with the two medications [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
At each visit local and systemic adverse effects that occurred during the treatment period will be recorded. Adverse events are evaluated by asking patients a general query about their state of health.
ocular surface indicators after 3 months of therapy with the two medications [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Selected indicators (break up time of tears, Schirmer test and degree of corneal stain after application of fluorescein) will be employed after 3 months of therapy to determine the health status of ocular surface with the two medications.


Enrollment:	42
Study Start Date:	January 2012
Study Completion Date:	January 2013
Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Travoprost/Timolol therapy Enrolled patients will be treated for 3 months with travoprost/timolol drops administered once in the evening. Evaluation of 24-hour pressure efficacy for this drug after 3 months of chronic therapy	Drug: Travoprost/timolol therapy Evaluation of 24-hour pressure efficacy with travoprost/timolol therapy after 3 months of chronic dosing Other Name: DuoTrav BAK Free Drug: Latanoprost/Timolol therapy Evaluation of 24-hour pressure efficacy for this drug after 3 months of chronic therapy Other Name: Xalacom
Active Comparator: Latanoprost/Timolol therapy Enrolled patients will be treated for 3 months with travoprost/timolol drops administered once in the evening. 24-hour pressure monitoring will be carried out for this drug after 3 months of chronic dosing. All patients will be crossed over to therapy for 3 months with latanoprost/timolol fixed combination drops administered once in the evening. Evaluation of 24-hour pressure efficacy for this drug after 3 months of chronic therapy	Drug: Travoprost/timolol therapy Evaluation of 24-hour pressure efficacy with travoprost/timolol therapy after 3 months of chronic dosing Other Name: DuoTrav BAK Free Drug: Latanoprost/Timolol therapy Evaluation of 24-hour pressure efficacy for this drug after 3 months of chronic therapy Other Name: Xalacom

Arms

Assigned Interventions

Active Comparator: Travoprost/Timolol therapy

Enrolled patients will be treated for 3 months with travoprost/timolol drops administered once in the evening. Evaluation of 24-hour pressure efficacy for this drug after 3 months of chronic therapy

Drug: Travoprost/timolol therapy

Evaluation of 24-hour pressure efficacy with travoprost/timolol therapy after 3 months of chronic dosing

Other Name: DuoTrav BAK Free

Drug: Latanoprost/Timolol therapy

Evaluation of 24-hour pressure efficacy for this drug after 3 months of chronic therapy

Other Name: Xalacom

Active Comparator: Latanoprost/Timolol therapy

Enrolled patients will be treated for 3 months with travoprost/timolol drops administered once in the evening. 24-hour pressure monitoring will be carried out for this drug after 3 months of chronic dosing. All patients will be crossed over to therapy for 3 months with latanoprost/timolol fixed combination drops administered once in the evening. Evaluation of 24-hour pressure efficacy for this drug after 3 months of chronic therapy

Drug: Travoprost/timolol therapy

Evaluation of 24-hour pressure efficacy with travoprost/timolol therapy after 3 months of chronic dosing

Other Name: DuoTrav BAK Free

Drug: Latanoprost/Timolol therapy

Evaluation of 24-hour pressure efficacy for this drug after 3 months of chronic therapy

Other Name: Xalacom

Eligibility


Ages Eligible for Study:	29 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Primary open-angle glaucoma or exfoliative glaucoma
Patients who require additional IOP lowering on latanoprost monotherapy
Morning IOP greater than 20 mm Hg on latanoprost monotherapy
Untreated morning IOP greater than 26 mm Hg
Patients older than 29 years
Patients with early to moderate glaucoma (less than 14 decibel (dB) mean deviation visual field loss attributed to glaucoma and 0.8 or better vertical cup-to-disc ratio)
On therapy with latanoprost monotherapy for at least 3 months
Patients with a reliable visual field
Best corrected distance Snellen visual acuity >1/10
Corneal pachymetry within the 550 ± 50 μm range
Patients should understand the study instructions
Patients willing to attend all follow-up appointments and willing to comply with study medication usage
Patients who have open, normal appearing angles

Exclusion Criteria:

History of combined topical therapy
Contraindication to prostaglandins or timolol
History of ocular trauma or inflammation; intraocular surgery; severe dry eyes; use of contact lenses
Sign of ocular infection except for mild blepharitis
Any corneal abnormality that could have affected the measurement of IOP
Chronic use of topical corticosteroids in the last 3 months before entering the study
Current, or previous use of systemic corticosteroid treatment
Uncontrolled systemic disease
Change of a systemic medication during the study period
Women of childbearing potential or lactating mothers
Inability to understand the instructions and adhere to medications

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01779284

Locations


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

Sponsors and Collaborators

Aristotle University Of Thessaloniki

More Information

No publications provided


Responsible Party:	AGP Konstas, Professor in Ophthalmology, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:	NCT01779284 History of Changes
Other Study ID Numbers:	A23
Study First Received:	January 25, 2013
Last Updated:	May 9, 2014
Health Authority:	Greece: National Organization of Medicines

Keywords provided by Aristotle University Of Thessaloniki:


glaucoma fixed combinations 24-hour monitoring

Additional relevant MeSH terms:


Latanoprost Timolol Travoprost Adrenergic Agents Adrenergic Antagonists Adrenergic beta-Antagonists Anti-Arrhythmia Agents	Antihypertensive Agents Cardiovascular Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015