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

Nuclear Cataract Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00825721
• Other study ID #: CK-0105
• Status: Active, not recruiting
• Phase: Phase 2
• First received: January 19, 2009
• Last updated: January 20, 2009
• Start date: November 2007
• Est. completion date: September 2009

Study information

• Verified date: January 2009
• Source: Chakshu Research, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationNepal: Nepal Health Research Council (NHRC)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 81
• Est. completion date: September 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 90 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Cataract
• Nuclear Cataract

Intervention

Drug:
• LiquiTears
4 drops applied daily for 360 days
• C-KAD Ophthalmic Solution
4 drops applied daily for 360 days
• C-KAD Ophthalmic Solution
4 drops applied daily for 360 days
• C-KAD Ophthalmic Solution
4 drops applied daily for 360 days

Locations

Country	Name	City	State
Nepal	Tilganga Eye Center	Kathmandu

Sponsors (1)

Lead Sponsor	Collaborator
Chakshu Research, Inc.

Country where clinical trial is conducted

Nepal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best-corrected visual acuity by ETDRS		360 days	Yes