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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Chakshu Research, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Chakshu Research, Inc.
ClinicalTrials.gov Identifier:
NCT00825721
First received: January 19, 2009
Last updated: January 20, 2009
Last verified: January 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Nuclear Cataract
 Drug: LiquiTears
Drug: C-KAD Ophthalmic Solution
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Chakshu Research, Inc.:

Primary Outcome Measures:
  • Best-corrected visual acuity by ETDRS [ Time Frame: 360 days ] [ Designated as safety issue: Yes ]

Enrollment: 81
Study Start Date: November 2007
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo Comparator: Placebo Drug: LiquiTears
4 drops applied daily for 360 days

  Eligibility

Ages Eligible for Study:   35 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00825721

Locations
Nepal
Tilganga Eye Center
Kathmandu, Nepal
Sponsors and Collaborators
Chakshu Research, Inc.
Investigators
Principal Investigator: Sanduk Ruit, MD Tilganga Eye Center
Principal Investigator: Reeta Gurung, MD Tilganga Eye Center
  More Information

No publications provided

Responsible Party: Watiri Kamau-Kelley /Manager, Clinical & Regulatory Affairs, Chakshu Reserach, Inc.
ClinicalTrials.gov Identifier: NCT00825721     History of Changes
Other Study ID Numbers: CK-0105
Study First Received: January 19, 2009
Last Updated: January 20, 2009
Health Authority: United States: Food and Drug Administration
Nepal: Nepal Health Research Council (NHRC)

Keywords provided by Chakshu Research, Inc.:
Cataract Study
Ophthalmic Study
Agerelated cataract
Nuclear Cataract
Low grade nuclear cataracts

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 23, 2013