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

April 16, 2009 updated by: Chakshu Research, Inc.

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

To determine the safety and initial efficacy of C-KAD ophthalmic solution in patients with asteroid hyalosis

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Mountain View, California, United States, 94041
        • Mountain View Optometry and Contact Lens Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Presence of asteroid hyalosis

Exclusion Criteria:

  • Active ocular infection
  • Glaucoma
  • Ocular hypertension
  • Ocular inflammatory disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: C-KAD Ophthalmic Solution
Drug: C-KAD Ophthalmic Solution
4 drops applied daily for 180 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction in the number of asteroid bodies
Time Frame: 180
180

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chakshu Research, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Anticipated)

October 1, 2009

Study Completion (Anticipated)

November 1, 2009

Study Registration Dates

First Submitted

January 19, 2009

First Submitted That Met QC Criteria

January 19, 2009

First Posted (Estimate)

January 21, 2009

Study Record Updates

Last Update Posted (Estimate)

April 17, 2009

Last Update Submitted That Met QC Criteria

April 16, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCK-0108

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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