Travoprost/Timolol vs Latanoprost/Timolol Fixed Combination Therapy

Aristotle University Of Thessaloniki

Status and phase: Completed; Phase 4

Conditions: Glaucoma

Treatments: Drug: Latanoprost/Timolol therapy; Drug: Travoprost/timolol therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01779284

A23

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 29 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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42 participants in 2 patient groups

Travoprost/Timolol therapy

Active Comparator group

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

Treatment:

Drug: Travoprost/timolol therapy

Drug: Latanoprost/Timolol therapy

Latanoprost/Timolol therapy

Active Comparator group

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

Treatment:

Drug: Travoprost/timolol therapy

Drug: Latanoprost/Timolol therapy