1 Year Study Trav/Brinz QD Fixed Combination Versus COSOPT

Phase 3TerminatedNCT00767481

Alcon Research6 enrolled

Overview

Parallel, Multi-Center, Double-masked, Active controlled, three arm study comparing the IOP lowering efficacy and safety over 12 months of morning or evening instillations of Travoprost/Brinzolamide vs. Cosopt dosed in the morning and evening in patients with open-angle glaucoma or ocular hypertension.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Glaucoma Ocular Hypertension

Interventions

Travoprost/BrinzolamideDRUG

Eye drop suspension, once daily

CosoptDRUG

Eye drop solution, one drop BID

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * IOP at screening visit \<18mmHg in at least one eye Mean IOP in same eye (at both eligibility 1 \&2 visits) * 24 and ≤ 36 mmHg at 9:00 * 21 and ≤ 36 mmHg at 11:00 and 16:00 Exclusion Criteria: * Severe central visual field loss Angle Shaffer grade \< 2 C/D ratio \> 0.8 (horizontal or vertical measurement)

Locations (1)

Unnamed facility

Mexico City, Mexico

Outcomes

Primary Outcomes

Mean IOP

Time frame: 9:00,11:00, and 1600 time points at month 12

Secondary Outcomes

Percent change in IOP, IOP change from baseline, patients with IOP <18mmHg. BSCVA, Ocular signs, Dilated fundus, perimetry, pachymetry, cardiovascular parameters(pulse, BP and AEs at W2, W3, M6, M9 and M12.

Time frame: All on therapy time points not included in primary efficacy

Data from ClinicalTrials.gov

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