Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

1 Year Study Trav/Brinz QD Fixed Combination Versus COSOPT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00767481
Recruitment Status : Terminated (Project Cancelled)
First Posted : October 7, 2008
Last Update Posted : July 19, 2012
Sponsor:
Collaborator:
PPD
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Glaucoma Ocular Hypertension Drug: Travoprost/Brinzolamide Drug: Cosopt Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : October 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009


Arm Intervention/treatment
Experimental: Travoprost/Brinzolamide PM, Vehicle AM
Travoprost/Brinzolamide PM, Vehicle AM
Drug: Travoprost/Brinzolamide
Eye drop suspension, once daily

Experimental: Travoprost/Brinzolamide AM, Vehicle PM
Travoprost/Brinzolamide AM, Vehicle PM
Drug: Travoprost/Brinzolamide
Eye drop suspension, once daily

Active Comparator: Cosopt
Cosopt BID
Drug: Cosopt
Eye drop solution, one drop BID




Primary Outcome Measures :
  1. Mean IOP [ Time Frame: 9:00,11:00, and 1600 time points at month 12 ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00767481


Locations
Layout table for location information
Mexico
Mexico City, Mexico, 6700
Sponsors and Collaborators
Alcon Research
PPD

Layout table for additonal information
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00767481     History of Changes
Other Study ID Numbers: C-08-16
2008-002781-66
First Posted: October 7, 2008    Key Record Dates
Last Update Posted: July 19, 2012
Last Verified: November 2011

Keywords provided by Alcon Research:
glaucoma
Patients with open-angle glaucoma or ocular hypertension

Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Glaucoma
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Travoprost
Brinzolamide
Antihypertensive Agents
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action