Back to results24-hr IOP With Travoprost/Timolol Compared With Latanoprost/Timolol in XFG
Primary Purpose
Glaucoma
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
treatment with latanoprost/timolol fixed combination
latanoprost/timolol fixed combination drops
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma focused on measuring 24-hour IOP, exfoliative glaucoma, travoprost/timolol, latanoprost/timolol, fixed combinations
Eligibility Criteria
Inclusion Criteria:
- Patient has XFG and is older than 29 years
- The IOP without treatment is greater than 25 mm Hg and lower than 40 mm Hg at baseline (2 readings at 10:00)
- Patient can be safely washed out without risk for significant deterioration
- Distance best corrected Snelen visual acuity better than 0.1
- No contraindication to prostaglandins or β-blockers
- No history of lack of response (<10% reduction) to any medication
- Patient can understand the instructions and comply to medications
- Open normal appearing angles
- No sign of ocular infection, except blepharitis, corneal abnormality that may affect IOP measurements etc
Exclusion Criteria:
- History of trauma, inflammation, surgery, past use of steroids (within 2 months), severe dry eyes and use of contact lenses
- Patient is a female of childbearing potential or lactating mother
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Travoprost/timolol therapy
Latanoprost/timolol therapy
Arm Description
treatment with travoprost/timolol fixed combination drops once in the evening for 3 months. 24-hour pressure monitoring.
Treatment with latanoprost/timolol fixed combination for 3 months. 24-hour pressure monitoring.
Outcomes
Primary Outcome Measures
Travoprost/timolol fixed combination will demonstrate better quality of 24-hour IOP control than latanoprost/timolol
Secondary Outcome Measures
Incidence of side effects with the two medications
Full Information
NCT ID
NCT00757835
First Posted
September 19, 2008
Last Updated
December 16, 2020
Sponsor
Aristotle University Of Thessaloniki
Collaborators
Alcon Research
1. Study Identification
Unique Protocol Identification Number
NCT00757835
Brief Title
24-hr IOP With Travoprost/Timolol Compared With Latanoprost/Timolol in XFG
Official Title
24-hour IOP Control With the Travoprost/Timolol Fixed Combination Compared With the Latanoprost/Timolol Fixed Combination, When Both Are Dosed in the Evening in Patients With Exfoliative Glaucoma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
May 2008 (Actual)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aristotle University Of Thessaloniki
Collaborators
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A crossover, randomized, single-masked study which compares the short-term (3 months) 24-hour IOP control and safety of travoprost/timolol fixed combination given once in the evening, versus that of latanoprost/timolol fixed combination given once in the evening in patients with exfoliative glaucoma. The primary objective of this trial is to compare the quality of 24-hour IOP control after 3 months of chronic therapy with these two medications.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
24-hour IOP, exfoliative glaucoma, travoprost/timolol, latanoprost/timolol, fixed combinations
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Travoprost/timolol therapy
Arm Type
Active Comparator
Arm Description
treatment with travoprost/timolol fixed combination drops once in the evening for 3 months. 24-hour pressure monitoring.
Arm Title
Latanoprost/timolol therapy
Arm Type
Active Comparator
Arm Description
Treatment with latanoprost/timolol fixed combination for 3 months. 24-hour pressure monitoring.
Intervention Type
Drug
Intervention Name(s)
treatment with latanoprost/timolol fixed combination
Intervention Description
dosing in the evening with the two fixed combinations
Intervention Type
Drug
Intervention Name(s)
latanoprost/timolol fixed combination drops
Intervention Description
once in the evening
Primary Outcome Measure Information:
Title
Travoprost/timolol fixed combination will demonstrate better quality of 24-hour IOP control than latanoprost/timolol
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Incidence of side effects with the two medications
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient has XFG and is older than 29 years
The IOP without treatment is greater than 25 mm Hg and lower than 40 mm Hg at baseline (2 readings at 10:00)
Patient can be safely washed out without risk for significant deterioration
Distance best corrected Snelen visual acuity better than 0.1
No contraindication to prostaglandins or β-blockers
No history of lack of response (<10% reduction) to any medication
Patient can understand the instructions and comply to medications
Open normal appearing angles
No sign of ocular infection, except blepharitis, corneal abnormality that may affect IOP measurements etc
Exclusion Criteria:
History of trauma, inflammation, surgery, past use of steroids (within 2 months), severe dry eyes and use of contact lenses
Patient is a female of childbearing potential or lactating mother
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anastasios G Konstas, MD, PhD
Organizational Affiliation
Glaucoma Unit, 1st University Department of Ophthalmology
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
24-hr IOP With Travoprost/Timolol Compared With Latanoprost/Timolol in XFG
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