Adherence Assessment With Travalert Dosing Aid

Alcon

Status and phase: Completed; Phase 4

Conditions: Open-angle Glaucoma; Ocular Hypertension

Treatments: Drug: Travoprost 0.004%/timolol 0.5% fixed combination eye drops (DuoTrav); Drug: Timolol 0.05% eye drops; Device: Travalert Dosing Aid; Drug: Travoprost 0.004% eye drops

Study type: Interventional

Funder types: Industry

Identifiers

NCT00508469

EMD-06-03

Details and patient eligibility

About

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.

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

Travalert with travoprost/timolol fixed combination

Experimental group

Description:

One drop in the study eye once daily at 9 p.m. for six months using the Travalert device.

Treatment:

Device: Travalert Dosing Aid

Drug: Travoprost 0.004%/timolol 0.5% fixed combination eye drops (DuoTrav)

Travalert with travoprost and timolol

Experimental group

Description:

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.

Treatment:

Drug: Travoprost 0.004% eye drops

Drug: Timolol 0.05% eye drops

Device: Travalert Dosing Aid