Adherence Assessment With Travalert Dosing Aid
Information source: Alcon Research
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Open-angle Glaucoma; Ocular Hypertension
Intervention: Travoprost 0.004%/timolol 0.5% fixed combination eye drops (DuoTrav) (Drug); Travoprost 0.004% eye drops (Drug); Timolol 0.05% eye drops (Drug); Travalert Dosing Aid (Device)
Phase: Phase 4
Status: Completed
Sponsored by: Alcon Research Official(s) and/or principal investigator(s): Dr Francisco M. Honrubia, Study Director, Affiliation: Independent
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.
Clinical Details
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%
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Adherence
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Zaragoza, Zaragoza 50009, Spain
Additional Information
Starting date: October 2007
Last updated: June 8, 2012
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