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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Chakshu Research, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Chakshu Research, Inc.
ClinicalTrials.gov Identifier:
NCT00825942
First received: January 19, 2009
Last updated: April 16, 2009
Last verified: April 2009
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   21 Years to 90 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

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
Study First Received: January 19, 2009
Last Updated: April 16, 2009
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Ophthalmic Solutions
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014