Travoprost/Timolol vs Latanoprost/Timolol Fixed Combination Therapy

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

AGP Konstas, Aristotle University Of Thessaloniki

ClinicalTrials.gov Identifier:

NCT01779284

First received: January 25, 2013

Last updated: January 30, 2013

Last verified: January 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	January 25, 2013
Last Updated Date	January 30, 2013
Start Date ^ICMJE	January 2012
Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 28, 2013)	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
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01779284 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 28, 2013)	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.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Travoprost/Timolol vs Latanoprost/Timolol Fixed Combination Therapy
Official Title ^ICMJE	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
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Glaucoma
Intervention ^ICMJE	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
Study Arm (s)	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 Interventions: Drug: Travoprost/timolol therapy Drug: Latanoprost/Timolol therapy 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 Interventions: Drug: Travoprost/timolol therapy Drug: Latanoprost/Timolol therapy
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	42
Completion Date	January 2013
Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	29 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Greece

Administrative Information
NCT Number ^ICMJE	NCT01779284
Other Study ID Numbers ^ICMJE	A23
Has Data Monitoring Committee	No
Responsible Party	AGP Konstas, Aristotle University Of Thessaloniki
Study Sponsor ^ICMJE	Aristotle University Of Thessaloniki
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Aristotle University Of Thessaloniki
Verification Date	January 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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