A Twelve-Week, Double Masked, Parallel Group, Study of Travoprost 0.004% Compared to Timolol 0.5% in Patients With Open-Angle Glaucoma or Ocular Hypertension
Overview
- Phase
- Phase 4
- Intervention
- Travoprost 0.004% Ophthalmic Solution (Travatan)
- Conditions
- Glaucoma
- Sponsor
- Alcon Research
- Enrollment
- 111
- Locations
- 1
- Primary Endpoint
- Mean Intraocular Pressure (IOP) at 9 AM
- Status
- Completed
- Last Updated
- 16 years ago
Overview
Brief Summary
To evaluate the Intraocular Pressure (IOP) lowering efficacy and safety of Travoprost 0.004% compared to Timolol 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OH). The study structure is a parallel design. The patients will receive treatment for 12 weeks.
Detailed Description
To evaluate the IOP lowering efficacy and safety fo Travoprost 0.004% compared to Timolol 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OH). The study structure is a parallel design. The patients will receive treatment for 12 weeks.
Investigators
Eligibility Criteria
Inclusion Criteria
- •≥18 years;
- •IOP=16-30mmHg
- •OH or OAG with visual filed abnormality:
- •≥3 adjacent points in 24 degrees field on the same side of the horizontal meridian, that have p \<5% on the prepapillary diameter plot, one of which must have p \<1%,
- •Glaucoma Hemifield Test outside normal limits,
- •Corrected Pattern Standard Deviation with p \<5%
Exclusion Criteria
- •Previous damage of anterior chamber angle;
- •ocular inflammation or ocular surgery within the past 3 months; Best Corrected Visual Acuity (logMAR) \<1.0;
- •contact lens wearer;
- •severe central field loss;
- •uncontrolled cardiovascular, hepatic or renal disease;
- •any medication within past 1 month.
Arms & Interventions
Travoprost 0.004%
Travoprost 0.004%
Intervention: Travoprost 0.004% Ophthalmic Solution (Travatan)
Timolol 0.5%
Timolol 0.5%
Intervention: Timolol 0.5% Ophthalmic Solution (Timoptic)
Outcomes
Primary Outcomes
Mean Intraocular Pressure (IOP) at 9 AM
Time Frame: At Week 12 - At the 9 AM time point for the patient's worse eye.
Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.
Week 12 - Mean IOP At 4 PM
Time Frame: At the 4 PM time point for the patient's worse eye.
Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.
Secondary Outcomes
- Mean IOP Change From Baseline at 9 AM(Baseline to Week 12 - at 9 AM)
- Mean IOP Change at 4 PM(Baseline to Week 12 - at 4 PM)