An Open-Label Study of an Ophthalmic Solution to Reduce Intraocular Pressure in Patients With Ocular Hypertension

June 9, 2009 updated by: Chakshu Research, Inc.

A Pilot, Open-Label, Controlled Clinical Trial of C-KAD Ophthalmic Solution in Reducing Intraocular Pressure in Patients With Ocular Hypertension

The purpose of this study is to determine the safety and tolerability of topical C-KAD Ophthalmic Solution in reducing intraocular pressure in patients with ocular hypertension.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Not Applicable

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

    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • Charlotte Eye, Ear, Nose & Throat Associates

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 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Both eyes having intraocular pressure in the range of 22-30 mmHg at baseline
  • Both eyes having best corrected visual acuity better than 20/50

Exclusion Criteria:

  • Advanced glaucoma
  • Closed or barely open anterior chamber or history of angle closure

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: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: C-KAD Ophthalmic Solution
4 drops applied daily for 150 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change in intraocular pressure from baseline
Time Frame: 150 Days
150 Days

Collaborators and Investigators

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

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

April 1, 2007

Primary Completion (ACTUAL)

April 1, 2009

Study Completion (ACTUAL)

April 1, 2009

Study Registration Dates

First Submitted

January 16, 2009

First Submitted That Met QC Criteria

January 16, 2009

First Posted (ESTIMATE)

January 21, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

June 11, 2009

Last Update Submitted That Met QC Criteria

June 9, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

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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