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: May 9, 2014
Last verified: May 2014
  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
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: 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: May 9, 2014
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 August 28, 2014