A 12-Month Study to Evaluate the Efficacy and Safety of Once-Daily Instillation of Combination Glaucoma Therapy in Patients With Open-Angle Glaucoma or Ocular Hypertension

Alcon

Status and phase: Completed; Phase 3

Conditions: Ocular Hypertension; Glaucoma, Open-angle

Treatments: Drug: Travoprost 0.004%/Timolol maleate 0.5% ophthalmic solution; Drug: Latanoprost 0.005%/Timolol 0.005% ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT00311389

C-02-28

Details and patient eligibility

About

The purpose of this study is to evaluate the intraocular pressure(IOP)-lowering efficacy of a combination IOP-lowering therapy in patients with open-angle glaucoma or ocular hypertension.

Enrollment: 408 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• As specified in protocol

Exclusion criteria

• As specified in protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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408 participants in 2 patient groups

Travoprost/Timolol

Experimental group

Description:

1 drop in the affected eye(s) once daily in the morning for 12 months

Treatment:

Drug: Travoprost 0.004%/Timolol maleate 0.5% ophthalmic solution

Latanoprost/Timolol

Active Comparator group

Description:

1 drop in the affected eye(s) once daily in the morning for 12 months

Treatment:

Drug: Latanoprost 0.005%/Timolol 0.005% ophthalmic solution