Travoprost/Timolol vs Latanoprost/Timolol Fixed Combination Therapy

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Glaucoma	Drug: Travoprost/timolol therapy; Drug: Latanoprost/Timolol therapy	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	42 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Single (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
Study Start Date :	January 2012
Actual Primary Completion Date :	December 2012
Actual Study Completion Date :	January 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. Mean 24-hour intraocular pressure reduction between the two medications [ Time Frame: 3 months ]
   Evaluation of 24-hour pressure every 4 hours at habitual position with calibrated Goldmann technology tonometer

Secondary Outcome Measures :

1. rate of adverse events with the two medications [ Time Frame: 3 months ]
   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.
2. ocular surface indicators after 3 months of therapy with the two medications [ Time Frame: 3 months ]
   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.

Eligibility Criteria

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Ages Eligible for Study:	29 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

Aristotle University Of Thessaloniki

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	AGP Konstas, Professor in Ophthalmology, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:	NCT01779284 History of Changes
Other Study ID Numbers:	A23
First Posted:	January 30, 2013
Last Update Posted:	May 12, 2014
Last Verified:	May 2014

Keywords provided by AGP Konstas, Aristotle University Of Thessaloniki:

glaucoma; fixed combinations; 24-hour monitoring

Additional relevant MeSH terms:

Glaucoma; Ocular Hypertension; Eye Diseases; Timolol; Latanoprost; Travoprost; Adrenergic beta-Antagonists	Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Anti-Arrhythmia Agents; Antihypertensive Agents