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Travoprost/Timolol vs Latanoprost/Timolol Fixed Combination Therapy

Primary Purpose

Glaucoma

Status
Completed
Phase
Phase 4
Locations
Greece
Study Type
Interventional
Intervention
Travoprost/timolol therapy
Latanoprost/Timolol therapy
Sponsored by
Aristotle University Of Thessaloniki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring glaucoma, fixed combinations, 24-hour monitoring

Eligibility Criteria

29 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Glaucoma Unit, 1st University Department of Ophthalmology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Travoprost/Timolol therapy

Latanoprost/Timolol therapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

Mean 24-hour intraocular pressure reduction between the two medications
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
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
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.

Full Information

First Posted
January 25, 2013
Last Updated
May 9, 2014
Sponsor
Aristotle University Of Thessaloniki
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1. Study Identification

Unique Protocol Identification Number
NCT01779284
Brief Title
Travoprost/Timolol vs Latanoprost/Timolol Fixed Combination Therapy
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 Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aristotle University Of Thessaloniki

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
glaucoma, fixed combinations, 24-hour monitoring

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Travoprost/Timolol therapy
Arm Type
Active Comparator
Arm Description
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
Arm Title
Latanoprost/Timolol therapy
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Travoprost/timolol therapy
Other Intervention Name(s)
DuoTrav BAK Free
Intervention Description
Evaluation of 24-hour pressure efficacy with travoprost/timolol therapy after 3 months of chronic dosing
Intervention Type
Drug
Intervention Name(s)
Latanoprost/Timolol therapy
Other Intervention Name(s)
Xalacom
Intervention Description
Evaluation of 24-hour pressure efficacy for this drug after 3 months of chronic therapy
Primary Outcome Measure Information:
Title
Mean 24-hour intraocular pressure reduction between the two medications
Description
Evaluation of 24-hour pressure every 4 hours at habitual position with calibrated Goldmann technology tonometer
Time Frame
3 months
Secondary Outcome Measure Information:
Title
rate of adverse events with the two medications
Description
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.
Time Frame
3 months
Title
ocular surface indicators after 3 months of therapy with the two medications
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
29 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Glaucoma Unit, 1st University Department of Ophthalmology
City
Thessaloniki
ZIP/Postal Code
546 36
Country
Greece

12. IPD Sharing Statement

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Travoprost/Timolol vs Latanoprost/Timolol Fixed Combination Therapy

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