Overview

This trial is active, not recruiting.

Condition nuclear cataract
Treatments liquitears, c-kad ophthalmic solution
Phase phase 2
Sponsor Chakshu Research, Inc.
Start date November 2007
End date August 2009
Trial size 81 participants
Trial identifier NCT00825721, CK-0105

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Active Comparator)
c-kad ophthalmic solution
4 drops applied daily for 360 days
(Active Comparator)
c-kad ophthalmic solution
4 drops applied daily for 360 days
(Active Comparator)
c-kad ophthalmic solution
4 drops applied daily for 360 days
(Placebo Comparator)
liquitears
4 drops applied daily for 360 days

Primary Outcomes

Measure
Best-corrected visual acuity by ETDRS
time frame: 360 days

Eligibility Criteria

Male or female participants from 35 years up to 90 years old.

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

Additional Information

Official title 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
Principal investigator Sanduk Ruit, MD
Trial information was received from ClinicalTrials.gov and was last updated in January 2009.
Information provided to ClinicalTrials.gov by Chakshu Research, Inc..