A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension

Alcon

Status and phase

Completed

Phase 3

Conditions

Open-Angle Glaucoma

Ocular Hypertension

Treatments

Drug: Travoprost 0.004%/Timolol 0.5% Ophthalmic Solution

Drug: Latanoprost 0.005% Ophthalmic Solution (XALATAN)

Drug: Timolol 0.5% Ophthalmic Solution

Other: Timolol Vehicle

Study type

Interventional

Funder types

Industry

Identifiers

NCT00293800

C-04-04

Details and patient eligibility

About

The purpose of the study is to evaluate the safety and effectiveness of an investigational glaucoma therapy in patients with open-angle glaucoma or ocular hypertension.

Enrollment

173 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

18 years or older.
Diagnosis of open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertension.
Mean intraocular pressure (IOP) in at least one eye greater than 21 mmHg and less than or equal to 36 mmHg at screening visit.
Other protocol-defined inclusion criteria may apply.

Exclusion criteria

Pregnant
History of chronic or recurrent severe inflammatory eye disease.
History of ocular infection or ocular inflammation within the past three months in either eye.
Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

173 participants in 2 patient groups

Travoprost/Timolol

Experimental group

Description:

One drop Travoprost 0.004%/Timolol 0.5% in the study eye(s) each morning at 8 a.m. and one drop Timolol vehicle in the study eye(s) each evening at 8 p.m. for 3 months

Treatment:

Drug: Travoprost 0.004%/Timolol 0.5% Ophthalmic Solution

Other: Timolol Vehicle

Xalatan + Timolol 0.5%

Active Comparator group

Description:

One drop Timolol 0.5% in the study eye(s) each morning at 8 a.m. and one drop Xalatan in the study eye(s) each evening at 8 p.m. for 3 months

Treatment:

Drug: Latanoprost 0.005% Ophthalmic Solution (XALATAN)

Drug: Timolol 0.5% Ophthalmic Solution