1 Year Study Trav/Brinz QD Fixed Combination Versus COSOPT - Full Text View

Sponsors and Collaborators:	Alcon Research PPD
Information provided by:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00767481

Purpose

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 Travoproost/Brinzolamide vs. Cosopt dosed in the morning and evening in patients with open-angle glaucoma or ocular hypertension.

Condition	Intervention	Phase
Glaucoma Ocular Hypertension	Drug: Travoprost/Brinzolamide Drug: Cosopt	Phase III

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

Drug Information available for: Azopt Cosopt Travoprost

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Alcon Research:

Primary Outcome Measures:

Mean IOP [ Time Frame: 9:00,11:00, and 1600 time points at month 12 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	600
Study Start Date:	October 2008
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Travoprost/Brinzolamide PM, Vehicle AM	Drug: Travoprost/Brinzolamide Eye drop suspension, once daily
2: Experimental Travoprost/Brinzolamide AM, Vehicle PM	Drug: Travoprost/Brinzolamide Eye drop suspension, once daily
3: Active Comparator Cosopt BID	Drug: Cosopt Eye drop solution, one drop BID

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00767481

Contacts

Contact: Alcon Call Center

1-888-451-3937

Locations

United States, Texas
Alcon Call Center for Trial Locations	Recruiting
Fort Worth, Texas, United States, 76134
Contact: Alcon Call Center 888-451-3937

Sponsors and Collaborators

Alcon Research

PPD

More Information

No publications provided

Responsible Party:	Alcon Research ( Ricardo Notivol, MD, Ph.D/Study Manager )
Study ID Numbers:	C-08-16, 2008-002781-66
Study First Received:	October 3, 2008
Last Updated:	April 6, 2009
ClinicalTrials.gov Identifier:	NCT00767481 History of Changes
Health Authority:	Argentina: Ministry of Health

Keywords provided by Alcon Research:

glaucoma
Patients with open-angle glaucoma or ocular hypertension

Study placed in the following topic categories:

Carbonic Anhydrase Inhibitors
Brinzolamide
Glaucoma
Eye Diseases
Glaucoma, Open-Angle
Vascular Diseases

Cardiovascular Agents
Tetrahydrozoline
Antihypertensive Agents
Travoprost
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Brinzolamide
Eye Diseases
Vascular Diseases
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

Travoprost
Carbonic Anhydrase Inhibitors
Glaucoma
Therapeutic Uses
Cardiovascular Diseases
Hypertension
Ocular Hypertension

ClinicalTrials.gov processed this record on May 07, 2009