NCT00906594

Brief Summary

The purpose of this study is to evaluate the additive effect of dorzolamide/timolol fixed combination in patients undergoing monotherapy with latanoprost.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 21, 2009

Completed
Last Updated

August 18, 2015

Status Verified

August 1, 2015

Enrollment Period

4 months

First QC Date

May 18, 2009

Last Update Submit

August 15, 2015

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

  • additional IOP reduction obtained with cosopt in addition to xalatan

    4 week

Study Arms (2)

Latanoprost

ACTIVE COMPARATOR

Latanoprost mono therapy

Drug: latanoprost

Latanoprost + Fixed combination

EXPERIMENTAL

Latnoprost + Fixed combination

Drug: latanoprost

Interventions

latanoprostDRUG
LatanoprostLatanoprost + Fixed combination

Eligibility Criteria

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

You may qualify if:

  • All patients were at least 18 years old, with unilateral or bilateral open-angle glaucoma (defined as IOP \> 21 mmHg, mean of three consecutive measurements, at any time during the day, at the moment of glaucoma diagnosis) or ocular hypertension (IOP\> 25 mmHg, mean of three consecutive measurements, at anytime during the day, at the moment of diagnosis). Glaucoma was defined as a reproducible glaucomatous visual field defect based on GHT outside normal limits and/or PSD lower than 0,5% or glaucomatous changes of the optic disc associated to elevated IOP. A visual acuity (ETDRS) of 20/80 or better was required for randomization.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sao Paulo

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Latanoprost

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Glaucoma Service

Study Record Dates

First Submitted

May 18, 2009

First Posted

May 21, 2009

Study Start

September 1, 2007

Primary Completion

January 1, 2008

Study Completion

July 1, 2008

Last Updated

August 18, 2015

Record last verified: 2015-08

Locations

BR(1)