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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014