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Adherence Assessment With Travalert Dosing Aid

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00508469
First Posted: July 30, 2007
Last Update Posted: July 12, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alcon Research
  Purpose
The purpose of the study is to compare adherence in patients on a fixed combination of travoprost 0.004%/timolol 0.5% and patients on a concomitant combination of travoprost 0.004% and timolol 0.5% using the Travalert® device.

Condition Intervention Phase
Open-angle Glaucoma Ocular Hypertension Drug: Travoprost 0.004%/timolol 0.5% fixed combination eye drops (DuoTrav) Drug: Travoprost 0.004% eye drops Drug: Timolol 0.05% eye drops Device: Travalert Dosing Aid Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adherence of Patients Using Travalert® for Instillation of a Fixed Combination of Travoprost 0.004%/Timolol 0.5% Compared to a Concomitant Regimen of Travoprost 0.004% and Timolol 0.5%

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Adherence [ Time Frame: 6 months ]
    Patients were considered adherent if a minimum of 80% of their instillations were administered ±2 hours of the scheduled time.


Enrollment: 102
Study Start Date: October 2007
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Travalert with travoprost/timolol fixed combination
One drop in the study eye once daily at 9 p.m. for six months using the Travalert device.
Drug: Travoprost 0.004%/timolol 0.5% fixed combination eye drops (DuoTrav)
One drop in the study eye once daily at 9 p.m. for six months using the Travalert device.
Other Name: DuoTrav®
Device: Travalert Dosing Aid
Approved device used with study medication to record time of instillation and quantify dosing
Experimental: Travalert with travoprost and timolol
One drop travoprost in the study eye at 9 p.m. and one drop of timolol in the study eye twice daily (9 a.m. and 9 p.m.) for six months using a separate Travalert device for each medication.
Drug: Travoprost 0.004% eye drops
One drop in the study eye once daily at 9 p.m. for six months using the Travalert device.
Drug: Timolol 0.05% eye drops
One drop in the study eye twice daily at 9 a.m. and 9 p.m. for six months using the Travalert device.
Device: Travalert Dosing Aid
Approved device used with study medication to record time of instillation and quantify dosing

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of open-angle glaucoma or ocular hypertension;
  • Inadequate control with beta-blocker or prostaglandin monotherapy and starting therapy with travoprost 0.004% and timolol 0.05%;
  • Intraocular pressure (IOP) at the screening visit in at least one eye ≥ 19 mmHg but not exceeding 36 mmHg in either eye;
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Females of childbearing potential currently pregnant, breastfeeding, or not taking control measures to prevent pregnancy;
  • Not currently receiving treatment for lowering IOP with beta-blockers or prostaglandin analogs;
  • Currently on therapy or was in therapy with another investigational agent within 30 days prior to the baseline visit;
  • History of chronic or recurrent severe inflammatory eye disease, or history of ocular trauma within the past six (6) months, or history of ocular infection or ocular inflammation within the past three (3) months in either eye;
  • History of clinically significant or progressive retinal disease or history of any other severe ocular pathology in either eye that would preclude the administration of a topical prostaglandin analogue;
  • History of severe or serious hypersensitivity to prostaglandin drugs or their analogues, to topical or systemic beta-blockers, or to any components of the study medication;
  • Intraocular surgery within the past six (6) months or ocular laser surgery within the past three (3) months as determined by patient history and/or examination in either eye;
  • Any abnormality preventing reliable applanation tonometry of either eye;
  • Best-corrected visual acuity worse than 20/30 Snellen in either eye;
  • Use of any additional topical or systemic ocular hyposensitive medication during the study;
  • Other protocol-defined exclusion criteria may apply.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00508469


Locations
Spain
Zaragoza
Zaragoza, Spain, 50009
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Dr Francisco M. Honrubia Independent
  More Information

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00508469     History of Changes
Other Study ID Numbers: EMD-06-03
First Submitted: July 26, 2007
First Posted: July 30, 2007
Results First Submitted: June 8, 2012
Results First Posted: July 12, 2012
Last Update Posted: July 12, 2012
Last Verified: June 2012

Keywords provided by Alcon Research:
Intraocular pressure
Open-angle glaucoma
Ocular hypertension
Adherence
Compliance

Additional relevant MeSH terms:
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Ophthalmic Solutions
Tetrahydrozoline
Timolol
Travoprost
Pharmaceutical Solutions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Antihypertensive Agents