1 Year Study Trav/Brinz QD Fixed Combination Versus COSOPT

Alcon

Status and phase: Terminated; Phase 3

Conditions: Glaucoma; Ocular Hypertension

Treatments: Drug: Travoprost/Brinzolamide; Drug: Cosopt

Study type: Interventional

Funder types: Industry

Identifiers

NCT00767481

2008-002781-66

C-08-16

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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6 participants in 3 patient groups

Travoprost/Brinzolamide PM, Vehicle AM

Experimental group

Description:

Travoprost/Brinzolamide PM, Vehicle AM

Treatment:

Drug: Travoprost/Brinzolamide

Travoprost/Brinzolamide AM, Vehicle PM

Experimental group

Description:

Travoprost/Brinzolamide AM, Vehicle PM

Treatment:

Drug: Travoprost/Brinzolamide

Cosopt

Active Comparator group

Description:

Cosopt BID

Treatment:

Drug: Cosopt