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

Primary Purpose

Cataract

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
C-KAD Ophthalmic Solution
Placebo
Sponsored by
Chakshu Research, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pacific Eye SpecialistsRecruiting
  • Hunkeler Eye InstituteRecruiting
  • Minnesota Eye Consultants, PARecruiting
  • Charlotte Eye, Ear, Nose & Throat AssociatesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Best-corrected visual acuity by ETDRS

Secondary Outcome Measures

Full Information

First Posted
November 17, 2008
Last Updated
November 26, 2008
Sponsor
Chakshu Research, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00793091
Brief Title
Safety and Efficacy Study of an Ophthalmic Solution in Patients With Age-Related Cataract
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Unknown status
Study Start Date
November 2008 (undefined)
Primary Completion Date
August 2009 (Anticipated)
Study Completion Date
September 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Chakshu Research, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
C-KAD Ophthalmic Solution
Intervention Description
4 drops applied daily for 120 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
4 drops applied daily for 120 days
Primary Outcome Measure Information:
Title
Best-corrected visual acuity by ETDRS
Time Frame
120 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ira Wong, MD
Organizational Affiliation
Chakshu Research, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Pacific Eye Specialists
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leslie Lyssenko
Phone
650-726-1500
Email
leslie@pacificeyespecialists.com
First Name & Middle Initial & Last Name & Degree
Lee Schwartz, MD
Facility Name
Hunkeler Eye Institute
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margie Jones
Phone
913-338-4733
Email
mjones@hunkeler.com
First Name & Middle Initial & Last Name & Degree
John Hunkeler, MD
Facility Name
Minnesota Eye Consultants, PA
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Office
Phone
612-813-3607
Email
research@mneye.com
First Name & Middle Initial & Last Name & Degree
David Hardten, MD
Facility Name
Charlotte Eye, Ear, Nose & Throat Associates
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Merri Walker
Phone
704-295-3386
Email
mwalker@ceenta.com
First Name & Middle Initial & Last Name & Degree
Michael Rotberg, MD

12. IPD Sharing Statement

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

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