Travoprost/Timolol vs Latanoprost/Timolol Fixed Combination Therapy

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aristotle University Of Thessaloniki
• Treatments: Latanoprost; Timolol; Travoprost

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