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OpenTrials
Completed

NCT Number: NCT00508469

Adherence Assessment With Travalert Dosing Aid

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Zaragoza

Zaragoza, 50009, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Travoprost 0.004%/timolol 0.5% fixed combination eye drops (DuoTrav)

Drug

One drop in the study eye once daily at 9 p.m. for six months using the Travalert device.

Other names: DuoTrav®

travoprost 0.004% eye drops

Drug

One drop in the study eye once daily at 9 p.m. for six months using the Travalert device.

Timolol 0.05% eye drops

Drug

One drop in the study eye twice daily at 9 a.m. and 9 p.m. for six months using the Travalert device.

Travalert Dosing Aid

Device

Approved device used with study medication to record time of instillation and quantify dosing

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study 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%

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jul 30, 2007
Registry last updated
Jul 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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