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Travoprost/Timolol vs Latanoprost/Timolol Fixed Combination Therapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01779284
First Posted: January 30, 2013
Last Update Posted: May 12, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AGP Konstas, Aristotle University Of Thessaloniki
  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
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

Resource links provided by NLM:


Further study details as provided by AGP Konstas, Aristotle University Of Thessaloniki:

Primary Outcome Measures:
  • 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:
  • 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.

  • 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.


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

  Eligibility

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01779284


Locations
Greece
Glaucoma Unit, 1st University Department of Ophthalmology
Thessaloniki, Greece, 546 36
Sponsors and Collaborators
Aristotle University Of Thessaloniki
  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 Submitted: January 25, 2013
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