24-hour Study of Dorzolamide/Timolol and Latanoprost/Timolol Fixed Combinations

Sponsor

Aristotle University Of Thessaloniki (Other)

Overall Status

Completed

CT.gov ID

NCT00397241

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Open-angle Glaucoma	Drug: Drug: dorzolamide/timolol Drug: Drug: latanoprost/timolol Drug: dorzolamide/timolol and latanoprost Drug: placebo (artificial tears)	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

33 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Sep 1, 2006

Actual Primary Completion Date :

Dec 1, 2007

Actual Study Completion Date :

Dec 1, 2007

Outcome Measures

Primary Outcome Measures

24-hour IOP control with DTFC will be statistically similar with LTFC given once each evening and placebo in the morning. []
Adjunctive therapy with DTFC and latanoprost will provide significantly better 24-hour IOP control than both fixed combinations alone (DTFC and LTFC). []

Eligibility Criteria

Criteria

Ages Eligible for Study:

29 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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