NCT00763061 - Travatan Versus Timoptic in Treating Open-angle Glaucoma or Ocular Hypertension | Crick

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

111

Conditions

Glaucoma

Interventions

Travoprost 0.004% Ophthalmic Solution (Travatan)DRUG

Travoprost at 9 AM + Placebo \& 9 PM

Timolol 0.5% Ophthalmic Solution (Timoptic)DRUG

Timolol in each eye, twice daily at 9 AM \& 9 PM

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * ≥18 years; * IOP=16-30mmHg * OH or OAG with visual filed abnormality: 1. ≥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%, 2. Glaucoma Hemifield Test outside normal limits, 3. 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.

Locations (1)

Alcon Call Center

Fort Worth, Texas, United States

Outcomes

Primary Outcomes

Mean Intraocular Pressure (IOP) at 9 AM

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.

Time frame: At Week 12 - At the 9 AM time point for the patient's worse eye.

Week 12 - Mean IOP At 4 PM

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.

Time frame: At the 4 PM time point for the patient's worse eye.

Secondary Outcomes

Mean IOP Change From Baseline at 9 AM

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.

Time frame: Baseline to Week 12 - at 9 AM

Mean IOP Change at 4 PM

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.

Time frame: Baseline to Week 12 - at 4 PM