24-hour Intraocular Pressure (IOP) Control With Dorzolamide/Timolol and Latanoprost/Timolol Fixed Combination in Open-angle Glaucoma

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.

Sponsors

Lead Sponsor: Aristotle University Of Thessaloniki

Source Aristotle University Of Thessaloniki
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.

Overall Status Completed
Start Date September 2006
Completion Date December 2007
Primary Completion Date December 2007
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
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).
Enrollment 33
Condition
Intervention

Intervention Type: Drug

Intervention Name: Drug: dorzolamide/timolol

Intervention Type: Drug

Intervention Name: Drug: latanoprost/timolol

Intervention Type: Drug

Intervention Name: dorzolamide/timolol and latanoprost

Intervention Type: Drug

Intervention Name: placebo (artificial tears)

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

Gender: All

Minimum Age: 29 Years

Maximum Age: 80 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Anastasios GP Konstas, MD, PhD Principal Investigator Glaucoma Unit, A University Department of Ophthalmology, AHEPA Hospital, Thessaloniki, Greece
Location
Facility: Glaucoma Unit, A University Dept of Ophthalmology
Location Countries

Greece

Verification Date

May 2014

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Aristotle University Of Thessaloniki

Investigator Full Name: AGP Konstas

Investigator Title: Professor in Ophthalmology

Has Expanded Access No
Condition Browse
Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Treatment

Masking: Single (Investigator)

Source: ClinicalTrials.gov