Adherence Assessment With Travalert Dosing Aid (NCT00508469) | Clinical Trial Compass
CompletedPhase 4
Adherence Assessment With Travalert Dosing Aid
Spain102 participantsStarted 2007-10
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 his…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.