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

November 17, 2008
November 26, 2008
November 2008
August 2009   (final data collection date for primary outcome measure)
Best-corrected visual acuity by ETDRS [ Time Frame: 120 Days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00793091 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety and Efficacy Study of an Ophthalmic Solution in Patients With Age-Related Cataract
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

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Cataract
  • Drug: C-KAD Ophthalmic Solution
    4 drops applied daily for 120 days
  • Drug: Placebo
    4 drops applied daily for 120 days
  • Active Comparator: 1
    Intervention: Drug: C-KAD Ophthalmic Solution
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
September 2009
August 2009   (final data collection date for primary outcome measure)

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
Both
50 Years to 85 Years
No
Not Provided
United States
 
NCT00793091
CK-0109
No
Watiri Kamau-Kelley, Manager, Clinical & Regulatory Affairs, Chakshu Research, Inc.
Chakshu Research, Inc.
Not Provided
Study Director: Ira Wong, MD Chakshu Research, Inc.
Chakshu Research, Inc.
November 2008

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