An Open-Label Study of an Ophthalmic Solution to Reduce Intraocular Pressure in Patients With Ocular Hypertension

This study has been completed.

Sponsor:

Information provided by:

Chakshu Research, Inc.

ClinicalTrials.gov Identifier:

NCT00825396

First received: January 16, 2009

Last updated: June 9, 2009

Last verified: June 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

January 16, 2009

Last Updated Date

June 9, 2009

Start Date ^ICMJE

April 2007

Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Mean change in intraocular pressure from baseline [ Time Frame: 150 Days ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00825396 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

An Open-Label Study of an Ophthalmic Solution to Reduce Intraocular Pressure in Patients With Ocular Hypertension

Official Title ^ICMJE

A Pilot, Open-Label, Controlled Clinical Trial of C-KAD Ophthalmic Solution in Reducing Intraocular Pressure in Patients With Ocular Hypertension

Brief Summary

The purpose of this study is to determine the safety and tolerability of topical C-KAD Ophthalmic Solution in reducing intraocular pressure in patients with ocular hypertension.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Ocular Hypertension

Intervention ^ICMJE

Drug: C-KAD Ophthalmic Solution

4 drops applied daily for 150 days

Study Arm (s)

Experimental: C-KAD Ophthalmic Solution

Intervention: Drug: C-KAD Ophthalmic Solution

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

Completion Date

April 2009

Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Both eyes having intraocular pressure in the range of 22-30 mmHg at baseline
Both eyes having best corrected visual acuity better than 20/50

Exclusion Criteria:

Advanced glaucoma
Closed or barely open anterior chamber or history of angle closure

Gender

Both

Ages

50 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00825396

Other Study ID Numbers ^ICMJE

PCK-0106

Has Data Monitoring Committee

Responsible Party

Ellen Hoogeveen /Associate Director, Clinical & Regulatory Affairs, Chakshu Research, Inc.

Study Sponsor ^ICMJE

Chakshu Research, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Ira Wong, MD

Chakshu Research, Inc.

Information Provided By

Chakshu Research, Inc.

Verification Date

June 2009

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

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