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

Overview

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.

Full Title of Study: “A Pilot, Open-Label, Controlled Clinical Trial of C-KAD Ophthalmic Solution in Reducing Intraocular Pressure in Patients With Ocular Hypertension”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2009

Interventions

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

Arms, Groups and Cohorts

  • Experimental: C-KAD Ophthalmic Solution

Clinical Trial Outcome Measures

Primary Measures

  • Mean change in intraocular pressure from baseline
    • Time Frame: 150 Days

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chakshu Research, Inc.
  • Provider of Information About this Clinical Study
    • Ellen Hoogeveen /Associate Director, Clinical & Regulatory Affairs, Chakshu Research, Inc.
  • Overall Official(s)
    • Ira Wong, MD, Study Director, Chakshu Research, Inc.

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