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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00793091
Recruitment Status : Unknown
Verified November 2008 by Chakshu Research, Inc..
Recruitment status was:  Recruiting
First Posted : November 19, 2008
Last Update Posted : November 27, 2008
Sponsor:
Information provided by:
Chakshu Research, Inc.

Study Description
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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

Condition or disease Intervention/treatment Phase
Cataract Drug: C-KAD Ophthalmic Solution Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : November 2008
Estimated Primary Completion Date : August 2009
Estimated Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Best-corrected visual acuity by ETDRS [ Time Frame: 120 Days ]

Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00793091


Locations
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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
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Study Director: Ira Wong, MD Chakshu Research, Inc.
More Information
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Responsible Party: Watiri Kamau-Kelley, Manager, Clinical & Regulatory Affairs, Chakshu Research, Inc.
ClinicalTrials.gov Identifier: NCT00793091    
Other Study ID Numbers: CK-0109
First Posted: November 19, 2008    Key Record Dates
Last Update Posted: November 27, 2008
Last Verified: November 2008
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases
Ophthalmic Solutions
Pharmaceutical Solutions