24-hr IOP With Travoprost/Timolol Compared With Latanoprost/Timolol in XFG

This study has been completed.
Sponsor:
Collaborator:
Alcon Research
Information provided by (Responsible Party):
AGP Konstas, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:
NCT00757835
First received: September 19, 2008
Last updated: January 25, 2013
Last verified: January 2013
  Purpose

A crossover, randomized, single-masked study which compares the short-term (3 months) 24-hour IOP control and safety of travoprost/timolol fixed combination given once in the evening, versus that of latanoprost/timolol fixed combination given once in the evening in patients with exfoliative glaucoma. The primary objective of this trial is to compare the quality of 24-hour IOP control after 3 months of chronic therapy with these two medications.


Condition Intervention Phase
Glaucoma
Drug: treatment with latanoprost/timolol fixed combination
Drug: latanoprost/timolol fixed combination drops
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: 24-hour IOP Control With the Travoprost/Timolol Fixed Combination Compared With the Latanoprost/Timolol Fixed Combination, When Both Are Dosed in the Evening in Patients With Exfoliative Glaucoma

Resource links provided by NLM:


Further study details as provided by Aristotle University Of Thessaloniki:

Primary Outcome Measures:
  • Travoprost/timolol fixed combination will demonstrate better quality of 24-hour IOP control than latanoprost/timolol [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of side effects with the two medications [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: May 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Travoprost/timolol therapy
treatment with travoprost/timolol fixed combination drops once in the evening for 3 months. 24-hour pressure monitoring.
Drug: treatment with latanoprost/timolol fixed combination
dosing in the evening with the two fixed combinations
Drug: latanoprost/timolol fixed combination drops
once in the evening
Active Comparator: Latanoprost/timolol therapy
Treatment with latanoprost/timolol fixed combination for 3 months. 24-hour pressure monitoring.
Drug: treatment with latanoprost/timolol fixed combination
dosing in the evening with the two fixed combinations
Drug: latanoprost/timolol fixed combination drops
once in the evening

  Eligibility

Ages Eligible for Study:   21 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has XFG and is older than 29 years
  • The IOP without treatment is greater than 25 mm Hg and lower than 40 mm Hg at baseline (2 readings at 10:00)
  • Patient can be safely washed out without risk for significant deterioration
  • Distance best corrected Snelen visual acuity better than 0.1
  • No contraindication to prostaglandins or β-blockers
  • No history of lack of response (<10% reduction) to any medication
  • Patient can understand the instructions and comply to medications
  • Open normal appearing angles
  • No sign of ocular infection, except blepharitis, corneal abnormality that may affect IOP measurements etc

Exclusion Criteria:

  • History of trauma, inflammation, surgery, past use of steroids (within 2 months), severe dry eyes and use of contact lenses
  • Patient is a female of childbearing potential or lactating mother
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00757835

Sponsors and Collaborators
Aristotle University Of Thessaloniki
Alcon Research
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: NCT00757835     History of Changes
Other Study ID Numbers: A6219
Study First Received: September 19, 2008
Last Updated: January 25, 2013
Health Authority: Greece: National Organization of Medicines

Keywords provided by Aristotle University Of Thessaloniki:
24-hour IOP
exfoliative glaucoma
travoprost/timolol
latanoprost/timolol
fixed combinations

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Timolol
Latanoprost
Travoprost
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

ClinicalTrials.gov processed this record on April 22, 2014