Safety and Efficacy Study of an Ophthalmic Solution in Pa... | NCT00793091

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

NCT00793091

Sponsor

Chakshu Research, Inc.

Status

Unknown status

Last Update Posted

Nov 27, 2008Estimated

Enrollment

80Estimated

Phase

Phase 2

Conditions

Cataract

Interventions

C-KAD Ophthalmic Solution
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Aug 2009Estimated

Completion Date

Sep 2009Estimated

First Submitted Date

Nov 17, 2008

First Submission Date that Met QC Criteria

Nov 18, 2008

First Posted Date

Nov 19, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 26, 2008

Last Update Posted Date

Nov 27, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator		Drug: C-KAD Ophthalmic Solution
2	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
C-KAD Ophthalmic Solution	Drug	4 drops applied daily for 120 days	1

Measure	Description	Time Frame
Best-corrected visual acuity by ETDRS		120 Days

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ira Wong, MD	Chakshu Research, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pacific Eye Specialists	Recruiting	San Francisco	California	94115	United States

Condition Browse Module

MeSH Terms

ID	Term
D002386	Cataract

Ancestor Terms

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided