Completed
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
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
You may qualify if you...
- 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
You will not qualify if you...
- 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 Site Locations
Total: 1 location
1
Glaucoma Unit, 1st University Department of Ophthalmology
Thessaloniki, Greece, 546 36
Status Unknown
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here