Safety and Efficacy Study of an Ophthalmic Solution in Patients With Age-Related Cataract

Cataract Clinical Trial

Official title:

A Phase 2, Randomized, Placebo-Controlled, Double-Masked, Multicenter Safety and Efficacy Study of C-KAD Ophthalmic Solution in Patients With Loss of Visual Acuity Due to Age-Related Cataract

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00793091
• Other study ID #: CK-0109
• Status: Recruiting
• Phase: Phase 2
• First received: November 17, 2008
• Last updated: November 26, 2008
• Start date: November 2008
• Est. completion date: September 2009

Study information

• Verified date: November 2008
• 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 efficacy of C-KAD Ophthalmic Solution in improving visual acuity relative to placebo in patients with age-related cataract

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

• Presence of age-related cataract in the study eye

• Best-corrected visual acuity of 20/25 to 20/50 in the study eye

Exclusion Criteria:

• Any other clinical condition in the eye that may compromise vision

• Presence or History of Glaucoma

• Presence or history of diabetes

• Use of eyedrops

• Use of steroids

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract

Intervention

Drug:
• C-KAD Ophthalmic Solution
4 drops applied daily for 120 days
• Placebo
4 drops applied daily for 120 days

Locations

Country	Name	City	State
United States	Charlotte Eye, Ear, Nose & Throat Associates	Charlotte	North Carolina
United States	Minnesota Eye Consultants, PA	Minneapolis	Minnesota
United States	Hunkeler Eye Institute	Overland Park	Kansas
United States	Pacific Eye Specialists	San Francisco	California

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	Best-corrected visual acuity by ETDRS		120 Days	Yes