Clinical trial NCT01779284: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Keywords: glaucoma
fixed combinations
24-hour monitoring
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2013-01-30
Enrollment: 42
Sex: ALL
Minimum age (years): 29
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Mean 24-hour intraocular pressure reduction between the two medications
timeFrame: 3 months
Secondary outcomes:
measure: rate of adverse events with the two medications
timeFrame: 3 months
measure: ocular surface indicators after 3 months of therapy with the two medications
timeFrame: 3 months
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Glaucoma Unit, 1st University Department of Ophthalmology
Study officials:
References: