A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension
Overview
- Phase
- Phase 3
- Intervention
- Travoprost 0.004%/Timolol 0.5% Ophthalmic Solution
- Conditions
- Open-Angle Glaucoma
- Sponsor
- Alcon Research
- Enrollment
- 173
- Primary Endpoint
- Mean Intraocular Pressure (IOP) Change at 3 Months from Baseline
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
Investigators
Eligibility Criteria
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
- •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.
Arms & Interventions
Travoprost/Timolol
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
Intervention: Travoprost 0.004%/Timolol 0.5% Ophthalmic Solution
Travoprost/Timolol
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
Intervention: Timolol Vehicle
Xalatan + Timolol 0.5%
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
Intervention: Latanoprost 0.005% Ophthalmic Solution (XALATAN)
Xalatan + Timolol 0.5%
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
Intervention: Timolol 0.5% Ophthalmic Solution
Outcomes
Primary Outcomes
Mean Intraocular Pressure (IOP) Change at 3 Months from Baseline
Time Frame: 3 months