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An Open-Label Study of the Effect of an Ophthalmic Solution on Asteroid Hyalosis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2009 by Chakshu Research, Inc..
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00825942
First Posted: January 21, 2009
Last Update Posted: April 17, 2009
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.
Information provided by:
Chakshu Research, Inc.
  Purpose
To determine the safety and initial efficacy of C-KAD ophthalmic solution in patients with asteroid hyalosis

Condition Intervention Phase
Asteroid Hyalosis Drug: C-KAD Ophthalmic Solution Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study of the Effect of C-KAD Ophthalmic Solution on Asteroid Hyalosis

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

Primary Outcome Measures:
  • Reduction in the number of asteroid bodies [ Time Frame: 180 ]

Estimated Enrollment: 20
Study Start Date: July 2008
Estimated Study Completion Date: November 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: C-KAD Ophthalmic Solution Drug: C-KAD Ophthalmic Solution
4 drops applied daily for 180 days

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Presence of asteroid hyalosis

Exclusion Criteria:

  • Active ocular infection
  • Glaucoma
  • Ocular hypertension
  • Ocular inflammatory disorders
  Contacts and Locations
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): NCT00825942


Locations
United States, California
Mountain View Optometry and Contact Lens Clinic
Mountain View, California, United States, 94041
Sponsors and Collaborators
Chakshu Research, Inc.
Investigators
Study Director: Ira Wong, MD Chakshu Research, Inc.
  More Information

Responsible Party: Ellen Hoogeveen /Associate Director, Clinical & Regulatory Affairs, Chakshu Research, Inc.
ClinicalTrials.gov Identifier: NCT00825942     History of Changes
Other Study ID Numbers: PCK-0108
First Submitted: January 19, 2009
First Posted: January 21, 2009
Last Update Posted: April 17, 2009
Last Verified: April 2009

Keywords provided by Chakshu Research, Inc.:
Asteroid hyalosis
Opthalmic Study

Additional relevant MeSH terms:
Pharmaceutical Solutions
Ophthalmic Solutions