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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AGP Konstas, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:
NCT00397241
First received: November 6, 2006
Last updated: January 25, 2013
Last verified: January 2013
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (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.

Resource links provided by NLM:

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

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: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
  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
Investigators
Principal Investigator: Anastasios GP Konstas, MD, PhD Glaucoma Unit, A University Department of Ophthalmology, AHEPA Hospital, Thessaloniki, Greece
  More Information

No publications provided

Responsible Party: AGP Konstas, Professor in Ophthalmology, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT00397241     History of Changes
Other Study ID Numbers: A733
Study First Received: November 6, 2006
Last Updated: January 25, 2013
Health Authority: Greece: National Organization of Medicines

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

ClinicalTrials.gov processed this record on May 19, 2013