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

Phase 2

• Conditions: Cataract
• Interventions: Drug: C-KAD Ophthalmic Solution; Drug: Placebo

• Registration Number: NCT00793091
• Lead Sponsor: Chakshu Research, Inc.

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-11
• Study Start: 2008-11
• Study First Submitted: 2008-11-17
• Study First Submitted QC: 2008-11-18
• Study First Posted: 2008-11-19
• Last Update Submitted: 2008-11-26
• Last Update Posted: 2008-11-27
• Primary Completion: 2009-08
• Study Completion: 2009-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	C-KAD Ophthalmic Solution	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
Best-corrected visual acuity by ETDRS	120 Days

Trial Locations

Locations (4)

Minnesota Eye Consultants, PA; 🇺🇸 Minneapolis, Minnesota, United States

Hunkeler Eye Institute; 🇺🇸 Overland Park, Kansas, United States

Pacific Eye Specialists; 🇺🇸 San Francisco, California, United States

Charlotte Eye, Ear, Nose & Throat Associates; 🇺🇸 Charlotte, North Carolina, United States