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

This study has been completed.
Sponsor:
Information provided by:
Chakshu Research, Inc.
ClinicalTrials.gov Identifier:
NCT00825396
First received: January 16, 2009
Last updated: June 9, 2009
Last verified: June 2009
History of Changes
  Purpose

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.


Condition Intervention
Ocular Hypertension
 Drug: C-KAD Ophthalmic Solution

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot, Open-Label, Controlled Clinical Trial of C-KAD Ophthalmic Solution in Reducing Intraocular Pressure in Patients With Ocular Hypertension

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chakshu Research, Inc.:

Primary Outcome Measures:
  • Mean change in intraocular pressure from baseline [ Time Frame: 150 Days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 12
Study Start Date: April 2007
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: C-KAD Ophthalmic Solution Drug: C-KAD Ophthalmic Solution
4 drops applied daily for 150 days

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00825396

Locations
United States, North Carolina
Charlotte Eye, Ear, Nose & Throat Associates
Charlotte, North Carolina, United States, 28210
Sponsors and Collaborators
Chakshu Research, Inc.
Investigators
Study Director: Ira Wong, MD Chakshu Research, Inc.
  More Information

No publications provided

Responsible Party: Ellen Hoogeveen /Associate Director, Clinical & Regulatory Affairs, Chakshu Research, Inc.
ClinicalTrials.gov Identifier: NCT00825396     History of Changes
Other Study ID Numbers: PCK-0106
Study First Received: January 16, 2009
Last Updated: June 9, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 19, 2013