24-Hour Intraocular Pressure Control With Bimatoprost/Timolol Versus Latanoprost as First Choice

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AGP Konstas, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:
NCT01448837
First received: September 26, 2011
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

The primary objective of this crossover 24-hour Intraocular Pressure (IOP) trial is to compare the control obtained after 3 months of therapy with the bimatoprost/timolol fixed combination (BTFC, Ganfort) given once in the evening (20:00) versus latanoprost (Xalatan) administered once in the evening (20:00) in newly-diagnosed patients with exfoliation syndrome (XFS) and ocular hypertension, or exfoliative glaucoma (XFG) previously untreated and IOP greater than 29 mm Hg.


Condition Intervention Phase
Glaucoma
Drug: Bimatoprost/Timolol, 24-hour intraocular pressure monitoring
Drug: Latanoprost, 24-hour intraocular pressure monitoring
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 Intraocular Pressure Control Obtained With the Bimatoprost/Timolol Fixed Combination Compared With Latanoprost as First Choice Therapy in Subjects With Exfoliation Syndrome, or Exfoliative Glaucoma

Resource links provided by NLM:


Further study details as provided by Aristotle University Of Thessaloniki:

Primary Outcome Measures:
  • 24-hour IOP reduction between the two medications [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Bimatoprost/Timolol will obtain a statistically greater 24-hour IOP reduction than latanoprost and the mean 24-hour IOP difference between the two medications will be clinically meaningful (at least 2 mm Hg).


Enrollment: 37
Study Start Date: April 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Bimatoprost/Timolol drops
The patients will be treated with bimatoprost/timolol fixed combination therapy
Drug: Bimatoprost/Timolol, 24-hour intraocular pressure monitoring
Administered once in the evening
Other Names:
  • Ganfort
  • Xalatan
Drug: Latanoprost, 24-hour intraocular pressure monitoring
assessment of 24-hour efficacy for the two drugs after 3 months of chronic dosing
Other Names:
  • Ganfort
  • Xalatan
Active Comparator: Latanoprost drops
The patients will be crossed over to therapy with latanoprost
Drug: Bimatoprost/Timolol, 24-hour intraocular pressure monitoring
Administered once in the evening
Other Names:
  • Ganfort
  • Xalatan
Drug: Latanoprost, 24-hour intraocular pressure monitoring
assessment of 24-hour efficacy for the two drugs after 3 months of chronic dosing
Other Names:
  • Ganfort
  • Xalatan

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has exfoliation syndrome with ocular hypertension, or exfoliative glaucoma and is older than 29 years
  • Patient is newly diagnosed, or currently untreated and exhibits untreated morning IOP (2 separate IOP readings at 10:00)greater than 29 mm Hg in the study eye
  • Study patients should have mild to moderate exfoliative glaucoma (VF loss <12 dB; cupping 0.8 or less)
  • Patient with exfoliation syndrome should fulfill the IOP criterion (IOP > 29 mm Hg at 10:00)
  • Patient deemed by investigator to require significant IOP reduction to obtain desired target IOP
  • Patient agrees to be treated for at least 3 months with latanoprost and bimatoprost/timolol fixed combination drops dosed in the evening
  • In study eye distance best corrected Snelen visual acuity greater than 1/10

Exclusion Criteria:

  • Contraindications to therapy with latanoprost, bimatoprost, or β-blockers
  • History of non-adherence or previously recorded evidence of lack of response (<10% morning IOP reduction) to any antiglaucoma medication
  • Patient can not understand the instructions and adhere to medications
  • Patient is a female of childbearing potential or lactating mother
  • Past history of trauma, inflammation, surgery, past use of steroids (within 2 months), severe dry eyes and use of contact lenses
  • Signs of ocular infection, except blepharitis, or corneal abnormality that may affect IOP measurements
  • The other eye can not receive the same therapy, or remain without medical therapy
  • Closed angles
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01448837

Locations
Greece
Glaucoma Unit, 1st University Department of Ophthalmology
Thessaloniki, Greece
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Investigators
Principal Investigator: Anastasios G Konstas, MD, PhD Glaucoma Unit, 1st University Department of Ophthalmology
  More Information

No publications provided

Responsible Party: AGP Konstas, Professor in Ophthalmology, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT01448837     History of Changes
Other Study ID Numbers: A5134
Study First Received: September 26, 2011
Last Updated: May 9, 2014
Health Authority: Greece: National Organization of Medicines

Additional relevant MeSH terms:
Glaucoma
Exfoliation Syndrome
Ocular Hypertension
Eye Diseases
Iris Diseases
Uveal Diseases
Timolol
Latanoprost
Bimatoprost
Cloprostenol
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
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on September 14, 2014