Safety and Intraocular Pressure (IOP) Lowering Efficacy of Low Dose Travoprost

Alcon

Status and phase: Completed; Phase 2

Conditions: Open-angle Glaucoma; Ocular Hypertension

Treatments: Other: Vehicle; Drug: Travoprost ophthalmic solution, 0.0012%; Drug: Travoprost ophthalmic solution, 0.0008%; Drug: TRAVATAN; Drug: Travoprost ophthalmic solution, 0.001%

Study type: Interventional

Funder types: Industry

Identifiers

NCT00637130

C-06-11

Details and patient eligibility

About

The purpose of this study is to compare the safety and IOP-lowering efficacy of various low dose travoprost formulations in patients with open-angle glaucoma or ocular hypertension.

Enrollment: 138 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients 18 years of age or older, either sex or race with open-angle glaucoma or confirmed ocular hypertension
• Other protocol-defined inclusion criteria may apply

Exclusion criteria

• Age related
• Other protocol-defined exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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138 participants in 5 patient groups, including a placebo group

Travoprost 0.0008%

Experimental group

Description:

Travoprost ophthalmic solution, 0.0008%, one drop in study eye(s) twice daily (8 AM and 8 PM), for 2 weeks

Treatment:

Drug: Travoprost ophthalmic solution, 0.0008%

Travoprost 0.001%

Experimental group

Description:

Travoprost ophthalmic solution, 0.001%, one drop in study eye(s) twice daily (8 AM and 8 PM), for 2 weeks

Treatment:

Drug: Travoprost ophthalmic solution, 0.001%

Travoprost 0.0012%

Experimental group

Description:

Travoprost ophthalmic solution, 0.0012%, one drop in study eye(s) twice daily (8 AM and 8 PM), for 2 weeks

Treatment:

Drug: Travoprost ophthalmic solution, 0.0012%

TRAVATAN + Vehicle

Active Comparator group

Description:

TRAVATAN, one drop in study eye(s) once daily (8 PM), and Vehicle, one drop in study eye(s) once daily (8 AM), for two weeks

Treatment:

Other: Vehicle

Drug: TRAVATAN

Vehicle

Placebo Comparator group

Description:

Vehicle, one drop in study eye(s) twice daily (8 AM and 8 PM), for 2 weeks

Treatment:

Other: Vehicle