Full Text View
Tabular View
No Study Results Posted
Related Studies
24-Hour Intraocular Pressure (IOP) Control With Dorzolamide/Timolol and Latanoprost/Timolol Fixed Combination in Open-Angle Glaucoma
This study has been completed.
First Received: November 6, 2006   Last Updated: September 19, 2008   History of Changes
Sponsors and Collaborators: Aristotle University Of Thessaloniki
Merck
Information provided by: Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT00397241
  Purpose

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 Intervention Phase
Open-Angle Glaucoma
Drug: Drug: dorzolamide/timolol
Drug: Drug: latanoprost/timolol
Drug: dorzolamide/timolol and latanoprost
Drug: placebo (artificial tears)
Phase IV

Genetics Home Reference related topics: early-onset glaucoma
MedlinePlus related topics: Glaucoma
Drug Information available for: Timolol Timolol maleate Dorzolamide Latanoprost Dorzolamide hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Investigator), Placebo Control, Crossover Assignment, Efficacy Study
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.

Further study details as provided by Aristotle University Of Thessaloniki:

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).

Enrollment: 33
Study Start Date: September 2006
Study Completion Date: October 2007
  Eligibility

Ages Eligible for Study:   29 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00397241

Locations
Greece
Glaucoma Unit, A University Dept of Ophthalmology
Thessaloniki, Greece, 546 43
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Merck
Investigators
Principal Investigator: Anastasios GP Konstas, MD, PhD Glaucoma Unit, A University Department of Ophthalmology, AHEPA Hospital, Thessaloniki, Greece
  More Information

No publications provided

Study ID Numbers: A733
Study First Received: November 6, 2006
Last Updated: September 19, 2008
ClinicalTrials.gov Identifier: NCT00397241     History of Changes
Health Authority: Greece: National Organization of Medicines

Study placed in the following topic categories:
Neurotransmitter Agents
Adrenergic Agents
Eye Diseases
Cardiovascular Agents
Antihypertensive Agents
Latanoprost
Carbonic Anhydrase Inhibitors
Glaucoma
Glaucoma, Open-Angle
Adrenergic beta-Antagonists
Adrenergic Antagonists
Timolol
Anti-Arrhythmia Agents
Ocular Hypertension
Hypertension
Dorzolamide

Additional relevant MeSH terms:
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Eye Diseases
Physiological Effects of Drugs
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Latanoprost
Pharmacologic Actions
Carbonic Anhydrase Inhibitors
Glaucoma
Therapeutic Uses
Glaucoma, Open-Angle
Adrenergic beta-Antagonists
Adrenergic Antagonists
Anti-Arrhythmia Agents
Timolol
Ocular Hypertension
Dorzolamide

ClinicalTrials.gov processed this record on May 07, 2009