Travoprost/Timolol vs Latanoprost/Timolol Fixed Combination Therapy

NCT ID: NCT01779284

Last Updated: 2014-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2013-01-31

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.

Conditions

Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Travoprost/timolol therapy

Intervention Type: DRUG

Evaluation of 24-hour pressure efficacy with travoprost/timolol therapy after 3 months of chronic dosing

Latanoprost/Timolol therapy

Intervention Type: DRUG

Evaluation of 24-hour pressure efficacy for this drug after 3 months of chronic therapy

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

Group Type: ACTIVE_COMPARATOR

Travoprost/timolol therapy

Intervention Type: DRUG

Evaluation of 24-hour pressure efficacy with travoprost/timolol therapy after 3 months of chronic dosing

Latanoprost/Timolol therapy

Intervention Type: DRUG

Evaluation of 24-hour pressure efficacy for this drug after 3 months of chronic therapy

Interventions

Travoprost/timolol therapy

Evaluation of 24-hour pressure efficacy with travoprost/timolol therapy after 3 months of chronic dosing

Intervention Type: DRUG

Latanoprost/Timolol therapy

Evaluation of 24-hour pressure efficacy for this drug after 3 months of chronic therapy

Intervention Type: DRUG

Other Intervention Names

DuoTrav BAK Free; Xalacom

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

• Minimum Eligible Age: 29 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aristotle University Of Thessaloniki

OTHER

Sponsor Role: lead

Responsible Party

AGP Konstas

Professor in Ophthalmology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Glaucoma Unit, 1st University Department of Ophthalmology

Thessaloniki, , Greece

Countries

Greece

Other Identifiers

A23

Identifier Type: -

Identifier Source: org_study_id