Travoprost/Timolol vs Latanoprost/Timolol Fixed Combination Therapy
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ClinicalTrials.gov Identifier: NCT01779284 |
Recruitment Status
:
Completed
First Posted
: January 30, 2013
Last Update Posted
: May 12, 2014
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Glaucoma | Drug: Travoprost/timolol therapy Drug: Latanoprost/Timolol therapy | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 42 participants |
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 |
Study Start Date : | January 2012 |
Actual Primary Completion Date : | December 2012 |
Actual Study Completion Date : | January 2013 |

Arm | Intervention/treatment |
---|---|
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
|
- 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
- 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.

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Ages Eligible for Study: | 29 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Greece | |
Glaucoma Unit, 1st University Department of Ophthalmology | |
Thessaloniki, Greece, 546 36 |
Responsible Party: | AGP Konstas, Professor in Ophthalmology, Aristotle University Of Thessaloniki |
ClinicalTrials.gov Identifier: | NCT01779284 History of Changes |
Other Study ID Numbers: |
A23 |
First Posted: | January 30, 2013 Key Record Dates |
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 |