Clinical trial NCT00397241: 24-hour Study of Dorzolamide/Timolol and Latanoprost/Timolol Fixed Combinations
Official title: 24-hour IOP With DTFC and LTFC Monotherapies and the Adjunctive Therapy of DTFC and Latanoprost in Open-angle Glaucoma Insufficiently Controlled With Latanoprost Monotherapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Open-angle Glaucoma
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2006-11-08
Enrollment: 33
Sex: ALL
Minimum age (years): 29
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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, versus latanoprost/timolol fixed combination (LTFC) given in the evening and placebo given in the morning, versus adjunctive therapy with DTFC given twice daily and latanoprost 0.005% given once in the evening in open-angle glaucoma patients who are insufficiently controlled with latanoprost monotherapy.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: 24-hour IOP control with DTFC will be statistically similar with LTFC given once each evening and placebo in the morning.
measure: Adjunctive therapy with DTFC and latanoprost will provide significantly better 24-hour IOP control than both fixed combinations alone (DTFC and LTFC).
Secondary outcomes:
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Glaucoma Unit, A University Dept of Ophthalmology
Study officials:
affiliation: Glaucoma Unit, A University Department of Ophthalmology, AHEPA Hospital, Thessaloniki, Greece
name: Anastasios GP Konstas, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: