Status:
COMPLETED
Travoprost/Timolol vs Latanoprost/Timolol Fixed Combination Therapy
Lead Sponsor:
Aristotle University Of Thessaloniki
Conditions:
Glaucoma
Eligibility:
All Genders
29-80 years
Phase:
PHASE4
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 in...
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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01779284
Start Date
January 1 2012
End Date
January 1 2013
Last Update
May 12 2014
Active Locations (1)
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1
Glaucoma Unit, 1st University Department of Ophthalmology
Thessaloniki, Greece, 546 36