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NCT00825396 Clinical Trial

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

Ocular Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00825396
Other study ID # PCK-0106
Secondary ID
Status Completed
Phase N/A
First received January 16, 2009
Last updated June 9, 2009
Start date April 2007
Est. completion date April 2009

Study information
Verified date June 2009
Source Chakshu Research, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date April 2009
Est. primary completion date April 2009
Accepts healthy volunteers No
Gender Both
Age group 50 Years to 90 Years
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• C-KAD Ophthalmic Solution
4 drops applied daily for 150 days

Locations
Country Name City State
United States Charlotte Eye, Ear, Nose & Throat Associates Charlotte North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Chakshu Research, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean change in intraocular pressure from baseline 150 Days Yes
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