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

November 26, 2008 updated by: Chakshu Research, Inc.

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

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
      • San Francisco, California, United States, 94115
        • Recruiting
        • Pacific Eye Specialists
        • Contact:
        • Principal Investigator:
          • Lee Schwartz, MD
    • Kansas
      • Overland Park, Kansas, United States, 66210
        • Recruiting
        • Hunkeler Eye Institute
        • Contact:
        • Principal Investigator:
          • John Hunkeler, MD
    • Minnesota
      • Minneapolis, Minnesota, United States, 55405
        • Recruiting
        • Minnesota Eye Consultants, PA
        • Contact:
        • Principal Investigator:
          • David Hardten, MD
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • Recruiting
        • Charlotte Eye, Ear, Nose & Throat Associates
        • Contact:
        • Principal Investigator:
          • Michael Rotberg, MD

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

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Drug: Placebo
4 drops applied daily for 120 days
Active Comparator: 1
Drug: C-KAD Ophthalmic Solution
4 drops applied daily for 120 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Best-corrected visual acuity by ETDRS
Time Frame: 120 Days
120 Days

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

November 1, 2008

Primary Completion (Anticipated)

August 1, 2009

Study Completion (Anticipated)

September 1, 2009

Study Registration Dates

First Submitted

November 17, 2008

First Submitted That Met QC Criteria

November 18, 2008

First Posted (Estimate)

November 19, 2008

Study Record Updates

Last Update Posted (Estimate)

November 27, 2008

Last Update Submitted That Met QC Criteria

November 26, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CK-0109

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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