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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
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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
Active Comparator: 1 Drug: C-KAD Ophthalmic Solution
4 drops applied daily for 120 days
Placebo Comparator: 2 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: Watiri Kamau-Kelley, Manager, Clinical & Regulatory Affairs, Chakshu Research, Inc.
ClinicalTrials.gov Identifier: NCT00793091     History of Changes
Other Study ID Numbers: CK-0109
Study First Received: November 17, 2008
Last Updated: November 26, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 19, 2013