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Safety and Efficacy Study of an Ophthalmic Solution in Patients With Age-Related Cataract

A Phase 2, Randomized, Placebo-Controlled, Double-Masked, Multicenter Safety and Efficacy Study of C-KAD Ophthalmic Solution in Patients With Loss of Visual Acuity Due to Age-Related Cataract

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00793091
Enrollment
80
Registered
2008-11-19
Start date
2008-11-30
Completion date
2009-09-30
Last updated
2008-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

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

Interventions

4 drops applied daily for 120 days

DRUGPlacebo

4 drops applied daily for 120 days

Sponsors

Chakshu Research, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Best-corrected visual acuity by ETDRS120 Days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026