Safety and Efficacy Study of an Ophthalmic Solution in Patients With Age-Related Cataract

The recruitment status of this study is unknown because the information has not been verified recently.

Verified November 2008 by Chakshu Research, Inc..
Recruitment status was Recruiting

Sponsor:

Information provided by:

Chakshu Research, Inc.

ClinicalTrials.gov Identifier:

NCT00793091

First received: November 17, 2008

Last updated: November 26, 2008

Last verified: November 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

November 17, 2008

Last Updated Date

November 26, 2008

Start Date ^ICMJE

November 2008

Estimated Primary Completion Date

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

Current Primary Outcome Measures ^ICMJE

Best-corrected visual acuity by ETDRS [ Time Frame: 120 Days ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00793091 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

Safety and Efficacy Study of an Ophthalmic Solution in Patients With Age-Related Cataract

Official Title ^ICMJE

A Phase 2, Randomized, Placebo-Controlled, Double-Masked, Multicenter Safety and Efficacy Study of C-KAD Ophthalmic Solution in Patients With Loss of Visual Acuity Due to Age-Related Cataract

Brief Summary

The purpose of this study is to determine the safety and efficacy of C-KAD Ophthalmic Solution in improving visual acuity relative to placebo in patients with age-related cataract

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Cataract

Intervention ^ICMJE

Drug: C-KAD Ophthalmic Solution
4 drops applied daily for 120 days
Drug: Placebo
4 drops applied daily for 120 days

Study Arm (s)

Active Comparator: 1
Intervention: Drug: C-KAD Ophthalmic Solution
Placebo Comparator: 2
Intervention: Drug: Placebo

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

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

September 2009

Estimated Primary Completion Date

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

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Presence of age-related cataract in the study eye
Best-corrected visual acuity of 20/25 to 20/50 in the study eye

Exclusion Criteria:

Any other clinical condition in the eye that may compromise vision
Presence or History of Glaucoma
Presence or history of diabetes
Use of eyedrops
Use of steroids

Gender

Both

Ages

50 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00793091

Other Study ID Numbers ^ICMJE

CK-0109

Has Data Monitoring Committee

Responsible Party

Watiri Kamau-Kelley, Manager, 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

November 2008

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

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