Adherence Assessment With Travalert Dosing Aid

Ocular Hypertension Clinical Trial

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%

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00508469
• Other study ID #: EMD-06-03
• Status: Completed
• Phase: Phase 4
• First received: July 26, 2007
• Last updated: June 8, 2012
• Start date: October 2007
• Est. completion date: January 2010

Study information

• Verified date: June 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma, Open-Angle
• Ocular Hypertension
• Open-angle Glaucoma

Intervention

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.
• Travoprost 0.004% eye drops
One drop in the study eye once daily at 9 p.m. for six months using the Travalert device.
• 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

Locations

Country	Name	City	State
Spain	Zaragoza	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence	Patients were considered adherent if a minimum of 80% of their instillations were administered ±2 hours of the scheduled time.	6 months	No