1 Year Study Trav/Brinz QD Fixed Combination Versus COSOPT

Glaucoma Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00767481
• Other study ID #: C-08-16
• Secondary ID: 2008-002781-66
• Status: Terminated
• Phase: Phase 3
• First received: October 3, 2008
• Last updated: July 18, 2012
• Start date: October 2008
• Est. completion date: February 2009

Study information

• Verified date: November 2011
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Ocular Hypertension

Intervention

Drug:
• Travoprost/Brinzolamide
Eye drop suspension, once daily
• Cosopt
Eye drop solution, one drop BID

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Alcon Research	PPD

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean IOP		9:00,11:00, and 1600 time points at month 12	Yes
Secondary	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.		All on therapy time points not included in primary efficacy	Yes