Adherence Assessment With Travalert Dosing Aid

Study Overview
=================
Brief 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.

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%

Conditions
-----------------
Open-angle Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: Travoprost 0.004%/timolol 0.5% fixed combination eye drops (DuoTrav)
* Drug: Travoprost 0.004% eye drops
* Drug: Timolol 0.05% eye drops
* Device: Travalert Dosing Aid


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Travalert with travoprost/timolol fixed combination<br>One drop in the study eye once daily at 9 p.m. for six months using the Travalert device. | Drug: Travoprost 0.004%/timolol 0.5% fixed combination eye drops (DuoTrav)<br>* One drop in the study eye once daily at 9 p.m. for six months using the Travalert device.<br>* Other names: DuoTrav®;Device: Travalert Dosing Aid<br>* Approved device used with study medication to record time of instillation and quantify dosing<br>|
| Experimental: Travalert with travoprost and timolol<br>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. | Drug: Travoprost 0.004% eye drops<br>* One drop in the study eye once daily at 9 p.m. for six months using the Travalert device.<br>Drug: Timolol 0.05% eye drops<br>* One drop in the study eye twice daily at 9 a.m. and 9 p.m. for six months using the Travalert device.<br>Device: Travalert Dosing Aid<br>* Approved device used with study medication to record time of instillation and quantify dosing<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence | Patients were considered adherent if a minimum of 80% of their instillations were administered ±2 hours of the scheduled time. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intraocular pressure, Open-angle glaucoma, Ocular hypertension, Adherence, Compliance