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

NCT ID: NCT00793091

Last Updated: 2008-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-09-30

Brief Summary

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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

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Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type ACTIVE_COMPARATOR

C-KAD Ophthalmic Solution

Intervention Type DRUG

4 drops applied daily for 120 days

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

4 drops applied daily for 120 days

Interventions

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C-KAD Ophthalmic Solution

4 drops applied daily for 120 days

Intervention Type DRUG

Placebo

4 drops applied daily for 120 days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chakshu Research, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Chakshu Research, Inc.

Principal Investigators

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Ira Wong, MD

Role: STUDY_DIRECTOR

Chakshu Research, Inc.

Locations

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Pacific Eye Specialists

San Francisco, California, United States

Site Status RECRUITING

Hunkeler Eye Institute

Overland Park, Kansas, United States

Site Status RECRUITING

Minnesota Eye Consultants, PA

Minneapolis, Minnesota, United States

Site Status RECRUITING

Charlotte Eye, Ear, Nose & Throat Associates

Charlotte, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Leslie Lyssenko

Role: primary

Margie Jones

Role: primary

Research Office

Role: primary

Merri Walker

Role: primary

Other Identifiers

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CK-0109

Identifier Type: -

Identifier Source: org_study_id