Dose Response Study of AL-37807 Ophthalmic Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension

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ClinicalTrials.gov Identifier: NCT00465621

Recruitment Status : Completed

First Posted : April 25, 2007

Last Update Posted : July 29, 2008

Sponsor:

Information provided by:

Alcon Research

Tracking Information

First Submitted Date ^ICMJE

April 23, 2007

First Posted Date ^ICMJE

April 25, 2007

Last Update Posted Date

July 29, 2008

Study Start Date ^ICMJE

March 2007

Actual Primary Completion Date

July 2007 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Mean IP Change from Baseline

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00465621 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Dose Response Study of AL-37807 Ophthalmic Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension

Official Title ^ICMJE

Dose Response Study of AL-37807 Ophthalmic Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension

Brief Summary

The purpose of thie study is to compare the safety and IOP-lowering efficacy of AL-37807 Ophthalmic Solution 0.05%, 0.1% and 0.2% dosed QD AM to Xalatan dosed QD PM and Vehicle in patients with open-angle glaucoma or ocular hypertension

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment

Condition ^ICMJE

Open-Angle Glaucoma
Ocular Hypertension

Intervention ^ICMJE

Drug: Xalatan

Study Arms

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

150

Original Enrollment ^ICMJE

Same as current

Study Completion Date

Not Provided

Actual Primary Completion Date

July 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Open-angle glaucoma
ocular hypertension

Exclusion Criteria:

- VA worse than 0.60

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00465621

Other Study ID Numbers ^ICMJE

C-06-10

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Alcon Research

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Theresa Landry

Alcon Research

PRS Account

Alcon Research

Verification Date

July 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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