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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

January 16, 2009
June 9, 2009
April 2007
April 2009   (final data collection date for primary outcome measure)
Mean change in intraocular pressure from baseline [ Time Frame: 150 Days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00825396 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
An Open-Label Study of an Ophthalmic Solution to Reduce Intraocular Pressure in Patients With Ocular Hypertension
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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Ocular Hypertension
Drug: C-KAD Ophthalmic Solution
4 drops applied daily for 150 days
Experimental: C-KAD Ophthalmic Solution
Intervention: Drug: C-KAD Ophthalmic Solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
April 2009
April 2009   (final data collection date for primary outcome measure)

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
Both
50 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00825396
PCK-0106
No
Ellen Hoogeveen /Associate Director, Clinical & Regulatory Affairs, Chakshu Research, Inc.
Chakshu Research, Inc.
Not Provided
Study Director: Ira Wong, MD Chakshu Research, Inc.
Chakshu Research, Inc.
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP