Back to resultsAn Open-Label Study of an Ophthalmic Solution to Reduce Intraocular Pressure in Patients With Ocular Hypertension
Primary Purpose
Ocular Hypertension
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
C-KAD Ophthalmic Solution
Sponsored by
About this trial
This is an interventional treatment trial for Ocular Hypertension
Eligibility Criteria
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
Sites / Locations
- Charlotte Eye, Ear, Nose & Throat Associates
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
C-KAD Ophthalmic Solution
Arm Description
Outcomes
Primary Outcome Measures
Mean change in intraocular pressure from baseline
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00825396
Brief Title
An Open-Label Study of an Ophthalmic Solution to Reduce Intraocular Pressure in Patients With Ocular Hypertension
Official Title
A Pilot, Open-Label, Controlled Clinical Trial of C-KAD Ophthalmic Solution in Reducing Intraocular Pressure in Patients With Ocular Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Chakshu Research, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
C-KAD Ophthalmic Solution
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
C-KAD Ophthalmic Solution
Intervention Description
4 drops applied daily for 150 days
Primary Outcome Measure Information:
Title
Mean change in intraocular pressure from baseline
Time Frame
150 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ira Wong, MD
Organizational Affiliation
Chakshu Research, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Charlotte Eye, Ear, Nose & Throat Associates
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
12. IPD Sharing Statement
Learn more about this trial
An Open-Label Study of an Ophthalmic Solution to Reduce Intraocular Pressure in Patients With Ocular Hypertension
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