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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00508469
Other study ID # EMD-06-03
Secondary ID
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


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
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