- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00825396
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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- PCK-0106
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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Alcon ResearchCompletedOcular Hypertension | Open-angle Glaucoma
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