Adherence Assessment With Travalert Dosing Aid

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%

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.

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Open-angle Glaucoma
• Intervention / Treatment: Drug: Travoprost 0.004%/timolol 0.5% fixed combination eye drops (DuoTrav); Device: Travalert Dosing Aid; Drug: Travoprost 0.004% eye drops; Drug: Timolol 0.05% eye drops

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Zaragoza, Spain, 50009
    • Zaragoza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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.	Device: Travalert Dosing Aid; Approved device used with study medication to record time of instillation and quantify dosing; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence	Patients were considered adherent if a minimum of 80% of their instillations were administered ±2 hours of the scheduled time.	6 months

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Dr Francisco M. Honrubia, Independent

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: July 26, 2007
• First Submitted That Met QC Criteria: July 27, 2007
• First Posted (Estimate): July 30, 2007

Study Record Updates

• Last Update Posted (Estimate): July 12, 2012
• Last Update Submitted That Met QC Criteria: June 8, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Open-angle glaucoma; Ocular hypertension; Adherence; Intraocular pressure; Compliance
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Pharmaceutical Solutions; Timolol; Ophthalmic Solutions; Travoprost
• Other Study ID Numbers: EMD-06-03