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: May 9, 2014
Last verified: May 2014

January 25, 2013
May 9, 2014
January 2012
December 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01779284 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Travoprost/Timolol vs Latanoprost/Timolol Fixed Combination Therapy
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Glaucoma
  • 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: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
January 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
29 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
NCT01779284
A23
No
AGP Konstas, Aristotle University Of Thessaloniki
Aristotle University Of Thessaloniki
Not Provided
Not Provided
Aristotle University Of Thessaloniki
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP