Glaucoma Clinical Trial
Official title:
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
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.
Status | Completed |
Enrollment | 42 |
Est. completion date | January 2013 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 29 Years to 80 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Greece | Glaucoma Unit, 1st University Department of Ophthalmology | Thessaloniki |
Lead Sponsor | Collaborator |
---|---|
Aristotle University Of Thessaloniki |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean 24-hour intraocular pressure reduction between the two medications | Evaluation of 24-hour pressure every 4 hours at habitual position with calibrated Goldmann technology tonometer | 3 months | No |
Secondary | rate of adverse events with the two medications | At each visit local and systemic adverse effects that occurred during the treatment period will be recorded. Adverse events are evaluated by asking patients a general query about their state of health. | 3 months | Yes |
Secondary | ocular surface indicators after 3 months of therapy with the two medications | Selected indicators (break up time of tears, Schirmer test and degree of corneal stain after application of fluorescein) will be employed after 3 months of therapy to determine the health status of ocular surface with the two medications. | 3 months | Yes |
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