A Phase IIIb Study of DuoTrav to Treat Glaucoma or Ocular Hypertension

Alcon

Status and phase: Completed; Phase 3

Conditions: Open-angle Glaucoma; Ocular Hypertension

Treatments: Drug: Travoprost ophthalmic solution, 0.004%; Drug: Timolol maleate ophthalmic solution, 0.5%; Drug: Travoprost 0.004%/timolol 0.5% ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT00465803

C-06-21

Details and patient eligibility

About

The purpose of this study is to assess patient compliance with DuoTrav versus concomitant administration of Timolol 0.5% plus TRAVATAN in patients with open-angle glaucoma or ocular hypertension.

Enrollment: 81 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients with open-angle glaucoma or ocular hypertension;
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Visual acuity worse than 0.60;
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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81 participants in 2 patient groups

DuoTrav

Other group

Description:

One drop in the study eye(s) once daily at either 8 AM or 8 PM for twelve months, as recorded by dosing aid

Treatment:

Drug: Travoprost 0.004%/timolol 0.5% ophthalmic solution

Travatan/Timolol

Other group

Description:

One drop Timolol in the study eye(s) once daily at 8 AM; one drop of Travatan in the study eye(s) once daily at 8 PM. Both products dosed for twelve months, as recorded by separate dosing aid for each product.

Treatment:

Drug: Timolol maleate ophthalmic solution, 0.5%

Drug: Travoprost ophthalmic solution, 0.004%