NCT00637130

Brief Summary

The purpose of this study is to compare the safety and IOP-lowering efficacy of various low dose travoprost formulations in patients with open-angle glaucoma or ocular hypertension.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
138

participants targeted

Target at P75+ for phase_2

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

October 1, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 29, 2008

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 17, 2008

Completed
Last Updated

December 6, 2012

Status Verified

December 1, 2012

Enrollment Period

3 months

First QC Date

February 29, 2008

Last Update Submit

December 4, 2012

Conditions

Open-angle GlaucomaOcular Hypertension

Outcome Measures

Primary Outcomes (1)

  • Mean Intraocular Pressure

    Up to 2 weeks

Study Arms (5)

Travoprost 0.0008%

EXPERIMENTAL

Travoprost ophthalmic solution, 0.0008%, one drop in study eye(s) twice daily (8 AM and 8 PM), for 2 weeks

Drug: Travoprost ophthalmic solution, 0.0008%

Travoprost 0.001%

EXPERIMENTAL

Travoprost ophthalmic solution, 0.001%, one drop in study eye(s) twice daily (8 AM and 8 PM), for 2 weeks

Drug: Travoprost ophthalmic solution, 0.001%

Travoprost 0.0012%

EXPERIMENTAL

Travoprost ophthalmic solution, 0.0012%, one drop in study eye(s) twice daily (8 AM and 8 PM), for 2 weeks

Drug: Travoprost ophthalmic solution, 0.0012%

TRAVATAN + Vehicle

ACTIVE COMPARATOR

TRAVATAN, one drop in study eye(s) once daily (8 PM), and Vehicle, one drop in study eye(s) once daily (8 AM), for two weeks

Drug: TRAVATANOther: Vehicle

Vehicle

PLACEBO COMPARATOR

Vehicle, one drop in study eye(s) twice daily (8 AM and 8 PM), for 2 weeks

Other: Vehicle

Interventions

Travoprost ophthalmic solution, 0.0008%DRUG
Travoprost 0.0008%
Travoprost ophthalmic solution, 0.001%DRUG
Travoprost 0.001%
Travoprost ophthalmic solution, 0.0012%DRUG
Travoprost 0.0012%
TRAVATANDRUG
TRAVATAN + Vehicle
VehicleOTHER
TRAVATAN + VehicleVehicle

Eligibility Criteria

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

You may qualify if:

  • Patients 18 years of age or older, either sex or race with open-angle glaucoma or confirmed ocular hypertension

You may not qualify if:

  • Age related

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Contact Alcon Call Center at 1-888-451-3937

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular Hypertension

Interventions

Travoprost

Condition Hierarchy (Ancestors)

GlaucomaEye Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 29, 2008

First Posted

March 17, 2008

Study Start

October 1, 2007

Primary Completion

January 1, 2008

Last Updated

December 6, 2012

Record last verified: 2012-12

Locations

US(1)