NCT00767481

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2008

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 3, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 7, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

July 19, 2012

Status Verified

November 1, 2011

Enrollment Period

4 months

First QC Date

October 3, 2008

Last Update Submit

July 18, 2012

Conditions

GlaucomaOcular Hypertension

Keywords

glaucomaPatients with open-angle glaucoma or ocular hypertension

Outcome Measures

Primary Outcomes (1)

  • Mean IOP

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

Secondary Outcomes (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.

    All on therapy time points not included in primary efficacy

Study Arms (3)

Travoprost/Brinzolamide PM, Vehicle AM

EXPERIMENTAL

Travoprost/Brinzolamide PM, Vehicle AM

Drug: Travoprost/Brinzolamide

Travoprost/Brinzolamide AM, Vehicle PM

EXPERIMENTAL

Travoprost/Brinzolamide AM, Vehicle PM

Drug: Travoprost/Brinzolamide

Cosopt

ACTIVE COMPARATOR

Cosopt BID

Drug: Cosopt

Interventions

Travoprost/BrinzolamideDRUG

Eye drop suspension, once daily

Travoprost/Brinzolamide AM, Vehicle PMTravoprost/Brinzolamide PM, Vehicle AM
CosoptDRUG

Eye drop solution, one drop BID

Cosopt

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • IOP at screening visit \<18mmHg in at least one eye Mean IOP in same eye (at both eligibility 1 \&2 visits)
  • and ≤ 36 mmHg at 9:00
  • and ≤ 36 mmHg at 11:00 and 16:00

You may not qualify if:

  • Severe central visual field loss Angle Shaffer grade \< 2 C/D ratio \> 0.8 (horizontal or vertical measurement)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Mexico City, 6700, Mexico

Location

MeSH Terms

Conditions

GlaucomaOcular Hypertension

Interventions

Travoprostbrinzolamidedorzolamide-timolol combination

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

CloprostenolProstaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2008

First Posted

October 7, 2008

Study Start

October 1, 2008

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

July 19, 2012

Record last verified: 2011-11

Locations

ME(1)