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

Phase 2

• Conditions: Nuclear Cataract
• Interventions: Drug: C-KAD Ophthalmic Solution; Drug: LiquiTears

• Registration Number: NCT00825721
• Lead Sponsor: Chakshu Research, Inc.

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Status Verified: 2009-01
• Study First Submitted: 2009-01-19
• Study First Submitted QC: 2009-01-20
• Last Update Submitted: 2009-01-20
• Study First Posted: 2009-01-21
• Last Update Posted: 2009-01-21
• Primary Completion: 2009-08
• Study Completion: 2009-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 81

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1.3% (low dose)	C-KAD Ophthalmic Solution	-
2% (medium dose)	C-KAD Ophthalmic Solution	-
2.6% (high dose)	C-KAD Ophthalmic Solution	-
Placebo	LiquiTears	-

Primary Outcome Measures

Name	Time	Method
Best-corrected visual acuity by ETDRS	360 days

Trial Locations

Locations (1)

Tilganga Eye Center; 🇳🇵 Kathmandu, Nepal