Adherence Assessment With Travalert Dosing Aid

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00508469
First received: July 26, 2007
Last updated: June 8, 2012
Last verified: June 2012

July 26, 2007
June 8, 2012
October 2007
January 2010   (final data collection date for primary outcome measure)
Adherence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Patients were considered adherent if a minimum of 80% of their instillations were administered ±2 hours of the scheduled time.
The primary objective is to compare patients adherence using Travalert® device in the different treatment groups. [ Time Frame: Use ]
Complete list of historical versions of study NCT00508469 on ClinicalTrials.gov Archive Site
Not Provided
Safety and satisfaction [ Time Frame: Use ]
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Open-angle Glaucoma
  • Ocular Hypertension
  • 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®
  • 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
  • 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.
    Interventions:
    • Drug: Travoprost 0.004%/timolol 0.5% fixed combination eye drops (DuoTrav)
    • Device: Travalert Dosing Aid
  • 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.
    Interventions:
    • Drug: Travoprost 0.004% eye drops
    • Drug: Timolol 0.05% eye drops
    • Device: Travalert Dosing Aid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
102
January 2010
January 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00508469
EMD-06-03
No
Alcon Research
Alcon Research
Not Provided
Study Director: Dr Francisco M. Honrubia Independent
Alcon Research
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP