Completed
24-Hour Efficacy of TravoprostTimolol Benzalkonium Chloride BAK Free Compared With LatanoprostTimolol Fixed Combination Therapy in Subjects With Open-Angle Glaucoma Insufficiently Controlled With Latanoprost Monotherapy
Led by Aristotle University Of Thessaloniki · Updated on 2014-05-12
42
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Brief Title
Travoprost/Timolol vs Latanoprost/Timolol Fixed Combination Therapy
Who Can Participate
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
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