Glaucoma
Conditions
Keywords
glaucoma, fixed combinations, 24-hour monitoring
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.
Interventions
DRUGTravoprost/timolol therapy
Evaluation of 24-hour pressure efficacy with travoprost/timolol therapy after 3 months of chronic dosing
DRUGLatanoprost/Timolol therapy
Evaluation of 24-hour pressure efficacy for this drug after 3 months of chronic therapy
Sponsors
Aristotle University Of Thessaloniki
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
29 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean 24-hour intraocular pressure reduction between the two medications | 3 months | Evaluation of 24-hour pressure every 4 hours at habitual position with calibrated Goldmann technology tonometer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| rate of adverse events with the two medications | 3 months | 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. |
| ocular surface indicators after 3 months of therapy with the two medications | 3 months | 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. |
Countries
Greece
Outcome results
None listed