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

This study is currently recruiting participants.

Verified by Chakshu Research, Inc., November 2008

First Received: November 17, 2008 Last Updated: November 26, 2008 History of Changes

Sponsor:	Chakshu Research, Inc.
Information provided by:	Chakshu Research, Inc.
ClinicalTrials.gov Identifier:	NCT00793091

Purpose

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

Condition	Intervention	Phase
Cataract	Drug: C-KAD Ophthalmic Solution Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Cataract

U.S. FDA Resources

Further study details as provided by Chakshu Research, Inc.:

Primary Outcome Measures:

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

Estimated Enrollment:	80
Study Start Date:	November 2008
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: C-KAD Ophthalmic Solution 4 drops applied daily for 120 days
2: Placebo Comparator	Drug: Placebo 4 drops applied daily for 120 days

Eligibility

Ages Eligible for Study:	50 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00793091

Locations

United States, California
Pacific Eye Specialists	Recruiting
San Francisco, California, United States, 94115
Contact: Leslie Lyssenko 650-726-1500 leslie@pacificeyespecialists.com
Principal Investigator: Lee Schwartz, MD
United States, Kansas
Hunkeler Eye Institute	Recruiting
Overland Park, Kansas, United States, 66210
Contact: Margie Jones 913-338-4733 mjones@hunkeler.com
Principal Investigator: John Hunkeler, MD
United States, Minnesota
Minnesota Eye Consultants, PA	Recruiting
Minneapolis, Minnesota, United States, 55405
Contact: Research Office 612-813-3607 research@mneye.com
Principal Investigator: David Hardten, MD
United States, North Carolina
Charlotte Eye, Ear, Nose & Throat Associates	Recruiting
Charlotte, North Carolina, United States, 28210
Contact: Merri Walker 704-295-3386 mwalker@ceenta.com
Principal Investigator: Michael Rotberg, MD

Sponsors and Collaborators

Chakshu Research, Inc.

Investigators

Study Director:

Ira Wong, MD

Chakshu Research, Inc.

More Information

No publications provided

Responsible Party:	Chakshu Research, Inc. ( Watiri Kamau-Kelley, Manager, Clinical & Regulatory Affairs )
Study ID Numbers:	CK-0109
Study First Received:	November 17, 2008
Last Updated:	November 26, 2008
ClinicalTrials.gov Identifier:	NCT00793091 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Eye Diseases
Cataract
Lens Diseases

ClinicalTrials.gov processed this record on November 30, 2009