NCT00444665

Brief Summary

Examine the safety, tolerability and efficacy of travoprost benzalkonium chloride (BAK) free ophthalmic solution compared to either latanoprost or bimatoprost monotherapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
750

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 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

First Submitted

Initial submission to the registry

March 7, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 8, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

November 21, 2016

Status Verified

April 1, 2008

Enrollment Period

3 months

First QC Date

March 7, 2007

Last Update Submit

November 18, 2016

Conditions

Glaucoma

Keywords

Glaucoma

Outcome Measures

Primary Outcomes (1)

  • Ocular Surface Disease Symptoms

Secondary Outcomes (1)

  • Intraocular pressure

Interventions

Travatan-ZDRUG

Eligibility Criteria

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

You may qualify if:

  • Adults with a clinical diagnosis of ocular hypertension, or primary open-angle, pigment dispersion or exfoliation glaucoma in at least one eye (study eye)

You may not qualify if:

  • Age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fridley

Fridley, Minnesota, 55432, United States

Location

Related Publications (1)

  • Henry JC, Peace JH, Stewart JA, Stewart WC. Efficacy, safety, and improved tolerability of travoprost BAK-free ophthalmic solution compared with prior prostaglandin therapy. Clin Ophthalmol. 2008 Sep;2(3):613-21. doi: 10.2147/opth.s3881.

    PMID: 19668762RESULT

MeSH Terms

Conditions

Glaucoma

Interventions

Travoprost

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Mark Jasek, PhD

    Alcon Research

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2007

First Posted

March 8, 2007

Study Start

May 1, 2007

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

November 21, 2016

Record last verified: 2008-04

Locations

US(1)