Recruiting
Phase 2

Ophthalmic Solution

Sponsor:

Chakshu Research, Inc.

Code:

NCT00793091

Conditions

Cataract

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

C-KAD Ophthalmic Solution

Placebo

Study Details

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

Conditions

Cataract

Study ID

NCT00793091

Start date

Nov, 2008

Status verified date

Nov, 2008

Completion date

Sep, 2009

Anticipated

Primary completion date

Aug, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 1

placebo comparator: 2

Interventions

C-KAD Ophthalmic Solution

4 drops applied daily for 120 days

Placebo

4 drops applied daily for 120 days

Primary outcome measure

  • Best-corrected visual acuity by ETDRS [ Time Frame: 120 Days ]

Central Contacts and Locations

Locations

Pacific Eye Specialists

Recruiting

San Francisco, California, United States, 94115

Contacts

Leslie Lyssenko

650-726-1500leslie@pacificeyespecialists.com

Principal Investigator:

Lee Schwartz, MD

Hunkeler Eye Institute

Recruiting

Overland Park, Kansas, United States, 66210

Contacts

Margie Jones

913-338-4733mjones@hunkeler.com

Principal Investigator:

John Hunkeler, MD

Minnesota Eye Consultants, PA

Recruiting

Minneapolis, Minnesota, United States, 55405

Contacts

Research Office

612-813-3607research@mneye.com

Principal Investigator:

David Hardten, MD

Charlotte Eye, Ear, Nose & Throat Associates

Recruiting

Charlotte, North Carolina, United States, 28210

Contacts

Merri Walker

704-295-3386mwalker@ceenta.com

Principal Investigator:

Michael Rotberg, MD

More Information

Sponsor

Chakshu Research, Inc.

Last update posted

Nov 27, 2008

Last verified

Nov, 2008

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Chakshu Research, Inc. on 2008-11-27.