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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00293800

Enrollment

173

Registered

2006-02-20

Start date

2004-07-31

Completion date

2005-12-31

Last updated

2012-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Open-Angle Glaucoma, Ocular Hypertension

Keywords

Open-angle, glaucoma, ocular, hypertension

Brief summary

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.

Interventions

DRUGTravoprost 0.004%/Timolol 0.5% Ophthalmic Solution

Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension

DRUGLatanoprost 0.005% Ophthalmic Solution (XALATAN)

Commercially marketed ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension

DRUGTimolol 0.5% Ophthalmic Solution

Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension

OTHERTimolol Vehicle

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Mean Intraocular Pressure (IOP) Change at 3 Months from Baseline	3 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026