Status:
COMPLETED
24-hour Study of Dorzolamide/Timolol and Latanoprost/Timolol Fixed Combinations
Lead Sponsor:
Aristotle University Of Thessaloniki
Conditions:
Open-angle 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 of dorzolamide/timolol fixed combination (DTFC) given twice daily, ve...
Eligibility Criteria
Inclusion
- Consecutive primary open-angle (POAG) and exfoliative glaucoma (XFG) patients will be recruited.
- Patients included will be older than 29 years
- Have early to moderate POAG, or XFG (less than 12 mean deviation visual field loss attributed to glaucoma and 0.8 or better vertical cup-to-disc ratio)
- Will be on therapy with latanoprost for more than 3 months;
- Have at treated baseline IOP at 10:00 (two consecutive readings) greater than 21 mm Hg
- Have a reliable visual field (at least two visual fields with less than 30% fixation losses, false positives or negatives)
- Have a best corrected distance Snellen visual acuity \> 1/10
- Have corneal pachymetry within the 550 ± 55 μm range, understand the study instructions and are willing to attend all follow-up appointments
- Are willing to comply with study medication usage
- And have open, normal appearing angles
Exclusion
- Patients will be excluded if they have: a risk for significant deterioration during the study
- Known previous history of lack of adequate response (\< 10% reduction) to any topical glaucoma medication
- Less than 20% daytime IOP reduction on latanoprost;
- Systemic contraindications to topical beta-blockers (asthma, bradycardia, severe congestive heart disease)
- Known contraindications to prostaglandins, history of ocular herpetic disease, or cystoid macular edema
- History of trauma, inflammation, surgery or past use of steroids (within two months)
- Severe dry eyes
- Use of contact lenses
- Signs of ocular infection, except blepharitis
- Corneal abnormality that may affect IOP measurements
- Unwillingness to accept the risk for hyperchromia of the iris or development of hypertrichosis
- And females of childbearing potential or lactating mothers
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00397241
Start Date
September 1 2006
End Date
December 1 2007
Last Update
December 19 2020
Active Locations (1)
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1
Glaucoma Unit, A University Dept of Ophthalmology
Thessaloniki, Greece, 546 43