Dose-Ranging Study of an Ophthalamic Solution in Patients With Loss of Visual Function Due to Age-Related Nuclear Cataract

January 20, 2009 updated by: Chakshu Research, Inc.

A Randomized, Placebo-Controlled, Single-Masked, Dose-Ranging Study of C-KAD Ophthalmic Solution in Patients With Loss of Visual Function Due to Age-Related Nuclear Cataracts

This study will evaluate the safety and efficacy of three doses of C-KAD Ophthalmic Solution in patients with loss of visual function due to age-related nuclear cataract

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nepal
      • Kathmandu, Nepal
        • Tilganga Eye Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Presence of nuclear sclerosis cataract
  • BCDVA within the range of 20/40 and 20/80

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: LiquiTears
4 drops applied daily for 360 days
Active Comparator: 1.3% (low dose)
Drug: C-KAD Ophthalmic Solution
4 drops applied daily for 360 days
Active Comparator: 2% (medium dose)
Drug: C-KAD Ophthalmic Solution
4 drops applied daily for 360 days
Active Comparator: 2.6% (high dose)
Drug: C-KAD Ophthalmic Solution
4 drops applied daily for 360 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Best-corrected visual acuity by ETDRS
Time Frame: 360 days
360 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chakshu Research, Inc.

Investigators

  • Principal Investigator: Sanduk Ruit, MD, Tilganga Eye Center
  • Principal Investigator: Reeta Gurung, MD, Tilganga Eye Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Anticipated)

August 1, 2009

Study Completion (Anticipated)

September 1, 2009

Study Registration Dates

First Submitted

January 19, 2009

First Submitted That Met QC Criteria

January 20, 2009

First Posted (Estimate)

January 21, 2009

Study Record Updates

Last Update Posted (Estimate)

January 21, 2009

Last Update Submitted That Met QC Criteria

January 20, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CK-0105

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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